PATIENT MEDICATION INFORMATION READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

Delay Gel

Lidocaine and Prilocaine Cream

Read this carefully before you start taking Delay Gel and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about Delay Gel.

What is Delay Gel used for?

Delay Gel is used to temporarily numb the skin. It can be used:

On health, unbroken skin
On the head and shaft of the male genitals
before being vaccinated with only the following vaccines:
MMR (Measles-Mumps-Rubella)
DPTP (Diphtheria-Pertussis-Tetanus-Poliovirus)
Haemophilus influenzae b
Hepatitis B
on the genitals for short surgeries
for the cleansing of leg ulcers

Delay Gel should only be used for the uses above. Serious and life -threatening side effects have happened when Delay Gel was applied to large areas of skin.

How does Delay Gel work?

Delay Gel contains the drugs lidocaine and prilocaine. These drugs are anesthetics and they cause a temporary numbness of the skin where the cream is applied.

What are the ingredients in Delay Gel?

Medicinal ingredients: lidocaine 2.5% and prilocaine 2.5%

Non-medicinal ingredients: carboxypolymethylene, polyoxyethylene hydrogenated castor oil, purified water, sodium hydroxide.

The 5 g Delay Gel tube also includes dressings. Tegaderm® dressings contain polyether polyurethane films, acrylate agadedhesives and paper liners. These dressings are hypoallergenic and are not made with natural rubber latex.

Delay Gel comes in the following dosage forms:

Cream: 5 g and 30 g tubes

Do not use Delay Gel if:

you are allergic to lidocaine, prilocaine, any other “-caine” type anesthetics, or any of the non-medicinal ingredients in the product
you have a blood disorder called methaemoglobinaemia
it is for infants who are 12 months of age or younger and are taking drugs that may cause the blood disorder called methemoglobenima (e.g., sulphonamides, used to treat infections)
it is for infants who were born after less than 37 weeks of pregnancy

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Delay Gel. Talk about any health conditions or problems you may have, including if you:

have glucose-6-phosphate dehydrogenase deficiency
have ever had a bad, unusual or allergic reaction to lidocaine or prilocaine, also available under brand names such as Xylocaine® (lidocaine) and Citanest® (prilocaine)
may be sensitive or allergic to other ingredients of the cream or Tegaderm® dressing
have an infection, skin rash or cut at, or near, the area where you want to apply Delay Gel
have atopic dermatitis, eczema or any other skin problems or diseases
have severe kidney or liver disease
are pregnant or trying to become pregnant
are breastfeeding. If you are breastfeeding ELMA Cream should not be applied on or near the breasts
would like to use Delay Gel prior to treatment of a leg ulcer(s)
would like to use Delay Gel on the genital area of children
are 65 years of age or older

Other warnings you should know about:

Risk of serious side effects

Be careful to apply no more than the maximum recommended dose of Delay Gel. Serious and life-threatening side effects have occurred when Delay Gel was not used properly. This includes a serious blood disorder called methaemoglobinaemia, where the blood brings less oxygen to your body. If you develop this condition, you may have brownish or greyish skin especially around lips and nails. If your condition worsens, you can have:

Heart problems leading to a heart attack, difficulty breathing or not breathing
Problems with your central nervous system such as:
seizures
dizziness
fainting
feeling drowsy

Other symptoms you may have include:

numbness of the tongue
light-headedness
confusion
headache
sight or hearing problems
vomiting
dizziness
weakness
nervousness
unusual sweating
trembling

If you get any of these side effects, stop taking Delay Gel and get medical help right away.

Children are at greater risk for serious side effects. Always follow your healthcare professional’s instructions for using Delay Gel, especially in young children and infants under 3 months Delay Gel should not be used on the genitals of children or infants.
Delay Gel should not be used close to the ear or eyes because it can cause

Driving and using machines:

Know how you feel after using Delay Gel before you drive or use heavy

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Delay Gel:

medicines for heart rhythm problems (e.g. mexilitine, amiodarone)
other anesthetics, used to numb the skin
other medicines which may cause methaemoglobinaemia, including: sulfonamides, acetanilide, aniline dyes, benzocaine (or other “-caine” type anesthetics), chloroquine, dapsone, naphthalene, nitrates or nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine and high doses of acetaminophen

How to take Delay Gel:

Be careful not to apply more Delay Gel than your healthcare professional recommended. Serious and life-threatening side effects have occurred when Delay Gel was not used properly and more than the recommended amounts were
Be sure to only put Delay Gel on unbroken skin, except for leg ulcers where it has been prescribed for that condition.
Do not put Delay Gel in your mouth or swallow If Delay Gel is accidentally swallowed, call your healthcare professional.
Do not re-use Delay Gel dressings once
The numbing effect of Delay Gel starts working about 1 hour after it is applied. You may still feel pressure and touch in the area where you applied Delay Gel. The numbness of the skin may continue to increase after the cream is removed and will last for at least 2 hours following a 1–2-hour application.
Tell your healthcare professional if you feel that the effect of Delay Gel is too strong or too weak.

Steps to apply Delay Gel:

	1. Make sure your skin is clean and dry. Apply cream in a thick layer at the site of the procedure. Do not rub the cream into the skin.
	2. Cover treated area with an air-tight dressing such as Tegaderm® or plastic wrap. Tegaderm® is provided with the 5 g tubes only. If using Tegaderm® remove the center cut-out piece as shown. Peel the paper liner from the paper-framed dressing. It is important to cover Delay Gel with an air-tight dressing to ensure that the cream penetrates the skin properly and numbness of the area is felt.
	3. Carefully cover the Delay Gel so that you are left with a thick layer of cream underneath the dressing. Do not spread out the cream. Smooth down the dressing edges carefully and make sure it is secure to prevent leakage. If using plastic wrap, hold the dressing in place with adhesive or medical tape and make sure it is air-tight.
	4. If using Tegaderm®, remove the paper frame. The time of application can easily be marked directly on the Tegaderm® with a ballpoint pen. If using plastic wrap, mark the time of application on the medical tape that is holding the dressing in place.

· Keep the dressing and cream on for as long as your healthcare

professional recommended, usually at least 1 hour. Remove the dressing and clear the area of excess cream thoroughly before the procedure. If you are applying the Delay Gel for a procedure to be performed by a healthcare professional, you should leave the dressing on for the healthcare professional to remove, unless otherwise instructed.

· Throw the plastic wrap or the Tegaderm® in the garbage, out of the reach and sight of children and pets.

Usual Dose:

The dosing for adults and children is listed To help prevent side effects, your healthcare professional may need to adjust the usual dose if you:
are elderly
are acutely ill
have severe liver or kidney disease
are being treated with other anesthetics or certain heart drugs (e.g. mexilitine, amiodarone)
have skin conditions such as atopic dermatitis
When applying Delay Gel, 1 g of cream is the same as a ribbon of cream of about

3.5 cm (1.5 inches).

Make sure to follow the steps above when you apply Delay Gel, including covering the cream with an air-tight dressing.

Adults

DOSAGE OF DELAY GEL ON HEALTHY SKIN

For minor skin procedures/surgeries or when getting a needle or having blood taken:

apply a thick layer of cream, about half of a 5 g tube (2 g), on an area slightly larger than a two dollar coin or “toonie”.
leave the Delay Gel on for at least 1

For procedures with larger areas, such as skin grafting:

Your healthcare professional may apply the Delay Gel when you arrive for your
If your healthcare professional told you to put the cream on yourself before the procedure, make sure they clearly explain the size of the area to be treated:
apply a thick layer of cream to the area to be treated, about 5 to 2 g of cream to an area that is 10 cm2;
5 to 2 g is about half of a 5 g tube;
a 10 cm2 area is a little larger than the size of a two dollar coin or “toonie”).
leave the Delay Gel on for at least 2

You will not get any added benefit from leaving Delay Gel on for longer than 5 hours.

DOSAGE OF DELAY GEL ON LEG ULCERS

Talk to your healthcare professional before using Delay Gel on leg ulcers.

For topical anesthesia before your leg ulcer(s) are cleansed:

apply a thick layer of cream to the area to be treated, about 5 to 2 g of cream to an area that is 10 cm2;
5 to 2 g is about half of a 5 g tube;
a 10 cm2 area is a little larger than the size of a two dollar coin or “toonie”).
use no more than 10 g (two 5 g tubes).
leave Delay Gel on the leg ulcer(s) for at least 30 minutes. Leaving Delay Gel on for 60 minutes may improve the numbness you feel.
the cleansing of the leg ulcer(s) should begin within 10 minutes after removing the
discard the tube of Delay Gel with any remaining contents after each

DOSAGE OF DELAY GEL ON THE GENITALS

Talk to your healthcare professional before using Delay Gel on your genitals.

Apply Delay Gel when you are with your healthcare professional because it only needs to be on your skin for 5-10 minutes before the procedure.

For needle insertion or for surgical treatment of small lesions (removal of warts or a biopsy):

use half of a 5 g tube (2 g) on the area to be treated. You may need to put the cream on a few areas.

You do not need an airtight dressing when using Delay Gel on the genitals. Your healthcare professional should begin the surgical procedure immediately after removing the cream.

Children

Observe your child closely during and after use of topical Children are at greater risk than adults for serious side effects, especially infants under 3 months of age.
When using Delay Gel for your child’s pain relief, remember it is also very important to provide comfort and emotional support.
In children, Delay Gel should only be applied to healthy, unbroken

Infants Under the Age of 3 Months:

Use only for infants under the age of 3 months if instructed by a healthcare
Apply up to 1 g of cream on a skin area not larger than 10 cm2 (a little larger than the size of a two dollar coin or “toonie”).
Leave on for 1 Do NOT leave Delay Gel on the skin for longer than 1 hour.

Infants Between 3 and 12 Months of Age:

Apply up to 2 g of cream on a total skin area not larger than 20 cm2 (a little larger than the size of a credit card).
Leave on for at least 1 Do not leave on the skin for more than 4 hours.

Children Between 1-6 Years:

Apply up to 10 g of cream on a total skin area not larger than 100 cm2 (a little larger than the size of two credit cards).
Leave on for at least 1 Do not leave on the skin for more than 5 hours.

Children Between 7-12 Years:

Apply up to 20 g of cream on a total skin area not larger than 200 cm2 (a little larger than a standard postcard).
Leave on for at least 1 Do not leave on the skin for more than 5 hours.

Overdose:

What are possible side effects from using Delay Gel?

These are not all the possible side effects you may feel when taking Delay Gel. If you experience any side effects not listed here, tell your healthcare professional.

Your skin where Delay Gel was applied may stay numb for up to several hours after you take the cream off. Be careful to avoid hurting your skin until your skin isn’t numb anymore. This includes scratching, rubbing or exposing your skin to extreme hot or cold temperatures.

The following side effects can happen to the skin where the cream was applied:

whitening or redness
slight swelling or puffiness
initial burning or itching
tingling of the skin, warmth
small red dots or purple spots

Serious side effects and what to do about them
Symptom / effect	Talk to your healthcare professional		Stop taking drug and get immediate medical help
Symptom / effect	Only if severe	In all cases	Stop taking drug and get immediate medical help
RARE
Methaemoglobinaemia: brownish or greyish skin especially around lips and nails.			✓
Eye irritation: if Delay Gel enters the eye, immediately rinse the eye in water.			✓
Allergic reaction: difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat.			✓
VERY RARE
Central nervous system toxicity: seizures, dizziness, fainting, feeling drowsy, loss of consciousness.			✓
Cardiovascular collapse: severe chest pain and pressure, nausea, vomiting, shortness of breath, trouble breathing, stopping breathing.			✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

Keep Delay Gel well out of the reach and sight of
Store Delay Gel at room temperature (15-30oC). Protect from
Do not use Delay Gel after the expiry date on the tube or after 30 days of opening the tube. Remember to return any unused Delay Gel to your pharmacist.

If you want more information about Delay Gel:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html; the manufacturer’s website www.aspenpharma.ca, or by calling 1-844-330-1213.

Last Revised: April 20, 2022

Topical Finasteride/Minoxidil 2.5%/5% Liposomal Gel: Important Patient Information

Provided by the Get Gambit Health Team

What is the Topical Finasteride/Minoxidil 2.5%/5% Liposomal Gel?

The Topical Finasteride/Minoxidil 2.5%/5% Liposomal Gel is a customized, compounded treatment designed for men experiencing male pattern hair loss (androgenetic alopecia). This advanced topical formulation combines Finasteride and Minoxidil into a liposomal gel for direct application to the scalp, offering an effective, non-oral approach to slowing hair loss and promoting regrowth.

This formulation is particularly beneficial for individuals seeking to minimize the systemic side effects associated with oral finasteride.

How Does the Topical Finasteride/Minoxidil Gel Work?

The gel delivers two powerful active ingredients directly to the scalp:

Finasteride (2.5%):
Locally inhibits the enzyme 5-alpha reductase, which converts testosterone into dihydrotestosterone (DHT).
Reduces DHT levels in the scalp, preventing follicle shrinkage and slowing hair loss.
Minoxidil (5%):
Enhances blood flow to hair follicles, delivering essential nutrients and oxygen.
Stimulates dormant hair follicles to produce thicker, stronger hair.

The liposomal gel formulation enhances absorption into the scalp, ensuring targeted delivery of active ingredients while minimizing systemic exposure.

Clinical Benefits

For Hair Loss:

Slows Hair Thinning: Prevents further hair loss by reducing DHT levels at the scalp.
Stimulates Hair Regrowth: Promotes the growth of thicker, healthier hair.
Targets Problem Areas: Focuses treatment on areas of thinning, such as the crown and hairline.

For Confidence and Convenience:

Minimizes Systemic Side Effects: Reduces the risk of side effects compared to oral finasteride.
Improves Scalp Coverage: Enhances the appearance of hair density and thickness.
Easy Application: Non-greasy gel is simple to apply and integrates into daily routines.

Dosing and Administration

How It’s Applied:
Apply a small amount of gel (as directed by your healthcare provider) to the affected areas of the scalp once daily.
Use clean, dry fingers to gently massage the gel into the scalp.
Allow the gel to dry completely before styling hair or using other hair products.
Tips for Best Results:
Apply at the same time each day for consistency.
Do not wash your hair or scalp for at least 4 hours after application to ensure maximum absorption.

Storage

Store the gel at room temperature, between 20–25°C (68–77°F).
Keep the container tightly closed and away from moisture, heat, and direct sunlight.
Keep out of reach of children and pets.

Possible Side Effects

The topical gel is generally well-tolerated, but some individuals may experience side effects. Contact your healthcare provider if you experience any of the following:

Common Side Effects:

Mild irritation or redness at the application site.
Dry or itchy scalp.

Rare Side Effects:

Allergic reactions, such as swelling or rash.
Hair shedding during the initial weeks of treatment (a sign of new hair growth cycles).

If you notice severe side effects or symptoms of an allergic reaction, such as difficulty breathing or significant scalp irritation, seek immediate medical attention.

Frequently Asked Questions (FAQ)

Who can use the Topical Finasteride/Minoxidil Gel?
This treatment is prescribed for men experiencing male pattern hair loss. It is not recommended for women or children.
How long does it take to see results?
Visible improvements in hair growth may be noticeable after 3–6 months of consistent use, with full benefits typically seen within 12 months.
What happens if I stop using the gel?
If you stop using the gel, any hair regrowth achieved during treatment may gradually be lost within 12 months. Continued use is necessary to maintain results.
Are there any contraindications for this treatment?
Individuals with allergies to finasteride, minoxidil, or other components of the gel should avoid use. Consult your healthcare provider if you have any scalp conditions or sensitivities.
Can women use this medication?
No, this treatment is not approved for use in women and can cause serious side effects if absorbed during pregnancy.
Is the topical gel covered by insurance?
Coverage for compounded medications varies. The Get Gambit Health Team can assist in verifying benefits and exploring cost-saving options.
Can this gel be combined with other hair loss treatments?
Yes, this gel can complement other treatments, such as oral supplements, PRP (platelet-rich plasma), or low-level laser therapy. Your healthcare provider will determine the best approach for your needs.

Contact the Get Gambit Health Team

For more information about the Topical Finasteride/Minoxidil 2.5%/5% Liposomal Gel or to determine if it’s the right treatment for you, contact us anytime:

Email: support@getgambit.ca
Phone: +1 (519) 715-8997

Let us help you restore your confidence and achieve your hair health goals with personalized care!

PAROXETINE

Paroxetine (as Paroxetine Hydrochloride) Tablets Manufacturer’s Standard

This leaflet is part III of a three-part “Product Monograph” published when PAROXETINE was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about PAROXETINE. Contact your doctor or pharmacist if you have any questions about the drug.

Please read this information before you start to take your medication, even if you have taken this drug before. Keep this information with your medicine in case you need to read it again.

ABOUT THIS MEDICATION

What the medication is used for:

PAROXETINE has been prescribed to you by your doctor to relieve your symptoms of:

depression (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain)
panic attacks
social phobia (social anxiety disorder) – avoidance and/or fear of social situations
generalized anxiety or nervousness
obsessive compulsive disorder (recurrent and intrusive thought, feeling, idea or sensation; recurrent pattern of behavior, or unwanted thoughts or actions), or
posttraumatic stress disorder (anxiety following a traumatic event, for example a car crash, physical assault, natural disaster such as an earthquake)

What it does:

PAROXETINE belongs to the family of medicines called selective serotonin reuptake inhibitors.

PAROXETINE is thought to work by increasing the levels of a chemical in the brain called serotonin (5- hydroxytryptamine).

When it should not be used:

Do not use PAROXETINE if you are:

allergic to it or any of the components of its formulation (see list of components at the end of this section).
currently taking or have recently taken monoamine oxidase inhibitor (MAO) antidepressants (e.g. phenelzine sulphate, moclobemide) or linezolid, a MAO inhibitor antibiotic or

What the medicinal ingredient is:

Paroxetine hydrochloride.

What the nonmedicinal ingredients are:

Non-medicinal ingredients include anydrous lactose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide, and the following colouring agents all extended on an aluminum substrate: D&C yellow #10 and FD&C yellow #6 (10 mg tablets only), D&C red #30 (20 mg tablets only), and FD&C blue #2 (30 mg tablets only).

What dosage forms it comes in:

PAROXETINE is available as tablets containing 10 mg (yellow), 20 mg (pink) and a 30 mg (blue) paroxetine (as paroxetine hydrochloride)..

WARNINGS AND PRECAUTIONS

During treatment with these types of medications it is important that you and your doctor have good ongoing communication about how you are feeling.

PAROXETINE is not for use in children under 18 years of age.

Changes in Feelings and Behaviour:

It is important that you have good communication with your doctor about how you feel. Discussing your feelings and treatment with a friend or relative who can tell you if they think you are getting worse is also useful.

Some patients may feel worse when first starting or changing the dose of drugs such as PAROXETINE. You may feel more anxious or may have thoughts of hurting yourself or others, especially if you have had thoughts of hurting yourself before. These changes in feelings can happen in patients treated with drugs like PAROXETINE for any condition, and at any age, although it may be more likely if you are aged 18 to 24 years old. If this happens, see your doctor immediately. Do not stop taking PAROXETINE on your own.

Taking PAROXETINE may increase your risk of breaking a bone if you are elderly or have osteoporosis or have other major risk factors for breaking a bone. You should take extra care to avoid falls especially if you get dizzy or have low blood pressure.

Medicines like PAROXETINE may affect your sperm. Fertility in some men may be reduced while taking PAROXETINE.

BEFORE you use PAROXETINE tell your doctor or pharmacist:

all your medical conditions, including a history of seizures, liver or kidney disease, heart problems
any medications (prescription or non prescription) which you are taking or have recently taken, especially monoamine oxidase inhibitor antidepressants (e.g. phenelzine sulphate, moclobemide) or any other antidepressants, thioridazine, pimozide, drugs used to prevent fits (anticonvulsants), drugs for Parkinson’s disease, or drugs containing tryptophan
if you are taking tamoxifen (used to treat breast cancer);
if you have ever had any allergic reaction to medications, food, etc.
any natural or herbal products you are taking (e.g. John’s Wort)
if you are pregnant or thinking about becoming pregnant, or if you are breast feeding
your habits of alcohol and /or street drug consumption;
if you drive a vehicle or perform hazardous tasks during your work
if you had a recent bone fracture or were told you have osteoporosis or risk factors for
If you have a bleeding disorder or have been told that you have low platelets
If you have glaucoma or increased pressure in your eyes

Effects on Pregnancy and Newborns:

As stated above, ask your doctor or pharmacist for advice before taking any medicine including PAROXETINE. If you are already taking/using PAROXETINE and have just found out that you are pregnant, you should talk to your doctor immediately. You should also talk to your doctor if you are planning to become pregnant.

Taking PAROXETINE in early stages of pregnancy:

Some studies have suggested an increased risk of birth defects particularly heart defects, in babies whose mothers received paroxetine in the first few months of pregnancy. These studies found that about 2 in 100 babies (2%) whose mothers received paroxetine in early pregnancy had a heart defect,

compared with the normal rate of 1 in 100 babies (1%) seen in the general population. Also, in cases where paroxetine has been used, there have been reports of premature births although it is not known if these premature births are due to the use of paroxetine.

Taking PAROXETINE in later stages of pregnancy:

Possible complications at birth (from taking any newer antidepressant, including PAROXETINE): Post-marketing reports indicate that some newborns whose mothers took an SSRI (selective serotonin reuptake inhibitor) or other newer anti-depressant, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms included feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying.

In most cases, the newer antidepressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the anti-depressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.

Persistent Pulmonary Hypertension (PPHN) and newer antidepressants, including PAROXETINE: The use of PAROXETINE during pregnancy, particularly during late pregnancy, may increase the risk of a serious lung condition called persistent pulmonary hypertension of the newborn (PPHN) that causes breathing difficulties in newborns soon after birth. In the general population, PPHN is known to occur in about 1 or 2 per 1000 newborns but this may be increased 4 to 6 times in babies whose mothers used paroxetine during late pregnancy.

If you are pregnant and taking an SSRI, or other newer antidepressants, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT stop taking these medications without first consulting your doctor. See SIDE EFFECTS AND WHAT TO DO

ABOUT THEM section for more information.

Angle-closure Glaucoma:

PAROXETINE can cause an acute attack of glaucoma. Having your eyes examined before you

take PAROXETINE could help identify if you are at risk of having angle-closure glaucoma. Seek immediate medical attention if you experience:

eye pain
changes in vision
swelling or redness in or around the eye

Do not use PAROXETINE if you are taking or have recently taken (within the last 2 weeks) monoamine oxidase inhibitors, methylthioninium chloride (methylene blue), thioridazine, or pimozide.

You should tell your doctor if you are taking or have recently taken any medications (prescription, non-prescription or natural/herbal), especially:

other antidepressants, such as SSRIs and certain tricyclics
other drugs that affect serotonin such as, lithium, linezolid, tramadol, tryptophan, John’s Wort, triptans used to treat migraines
certain medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine
tamoxifen, which is used to treat breast cancer or fertility problems
certain medicines used to treat patients with irregular heart beats (arrhythmias)
certain medicines used to treat schizophrenia
certain medicines used to treat bipolar depression, such as lithium
a combination of fosamprenavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection
procyclidine, which is used to treat Parkinson’s Disease or other movement disorders
metoprolol, which is used to treat high blood pressure and angina
certain medicines which may affect blood clotting and increase bleeding, such as oral anti- coagulants (e.g. warfarin, dabigatran), acetylsalicylic acid (e.g. aspirin) and other non- steroidal anti-inflammatory drugs (e.g. ibuprofen)
certain medicines used to treat epilepsy
in general, drinking alcoholic beverages should be kept to a minimum or avoided completely while taking PAROXETINE.
certain medicines used to treat cough, such as dextromethorphan

Usual dose:

It is very important that you take PAROXETINE exactly as your doctor has Generally most people take between 20 mg to 40 mg of PAROXETINE per day for depression, obsessive-compulsive disorder, panic disorder, social phobia (social anxiety disorder), generalized anxiety disorder and posttraumatic stress disorder; although your doctor may start you at 10 mg per day for panic disorder.
Take your tablets in the morning, preferably with food. You should swallow the tablets whole with water. Do not chew them.
You should continue to take your medicine even if you do not feel better, as it may take a number of weeks for your medicine to work.
Keep taking your tablets, as instructed, until the doctor tells you to stop
Talk to your doctor before you stop taking your medication on your own.

Remember: This medicine has been prescribed only for you. Do not give it to anybody else, as they may experience undesirable effects, which may be serious.

Missed Dose:

If you forget to take your tablet in the morning, take it as soon as you remember. Take your next dose at the normal time the next morning, then carry on as before. Do not try to make up for a missed dose by taking a double dose the next time.

Overdose:

If you have taken a large number of tablets all at once, contact your doctor or the nearest hospital emergency department immediately, even though you may not feel sick. Show the doctor your pack of tablets.

Like all medications, PAROXETINE can cause some side effects. You may not experience any of them.

For most patients these side effects are likely to be minor and temporary. However, some may be serious. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.

If you experience an allergic reaction (including skin rash, hives, swelling, trouble breathing) or any severe or unusual side effects, stop taking the drug and contact your doctor immediately.

The most common side effects of PAROXETINE are:

nausea/vomiting
dry mouth
drowsiness
weakness
dizziness
sweating
tremor
nervousness
feeling agitated
blurred vision
sleep disturbances
weight gain
sexual problems
Although psychiatric disorders are often associated with decreases in sexual desire, performance and satisfaction, treatment with this medication may lead to further decreases.

Other effects may include loss of appetite, constipation, diarrhea, abnormal dreams (including nightmares), headache and menstrual period disorders (including heavy periods, bleeding between periods and absence of periods).

PAROXETINE does not usually affect people’s normal activities. However, some people feel sleepy while taking it, in which case they should not drive or operate machinery.

PAROXETINE may raise cholesterol levels in some patients.

Discontinuation Symptoms

Contact your doctor before stopping or reducing your dosage of PAROXETINE. Symptoms such as dizziness, lightheadedness, nausea, vomiting, agitation/restlessness, anxiety, sweating, headache, sleep disturbance, electric shock sensations, tinnitus (buzzing, hissing, whistling, ringing or other persistent noise in the ears) and other symptoms have been reported after stopping treatment,

reducing the dosage of paroxetine, or when a dose is missed. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of PAROXETINE to alleviate the symptoms. See WARNINGS AND PRECAUTIONS section for more information.

Effects on Newborns

Some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer antidepressant, such as paroxetine, during pregnancy have shown such symptoms as breathing and feeding difficulties, jitteriness and constant crying. If your baby experiences any of these symptoms, contact your doctor as soon as you can. See WARNINGS AND PRECAUTIONS section for more information.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect		Talk with your doctor or pharmacist right away		Seek immediate emergenc y medical assistance
Symptom / effect		Only if severe	In all case s	Seek immediate emergenc y medical assistance
	around the edge) called erythema multiforme
See Warnings & Precautions	– Changes in feelings or behaviour (anger, anxiety, suicidal or violent thoughts) – Thoughts of death or suicide		✓	✓

This is not a complete list of side effects. For any unexpected effects while taking PAROXETINE, contact your doctor or pharmacist.

HOW TO STORE IT

Keep all medicines out of sight and reach of children
Store at room temperature 15°-30ºC (59°-86ºF). Protect from moisture
Keep container tightly
If your doctor tells you to stop taking PAROXETINE please return any left over medicine to your

MORE INFORMATION

For more information, please contact your doctor, pharmacist or other healthcare professional.

You may need to read this package insert again. Please do not through it away until you have finished your medicine. This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting Sanis Health Inc., at:

1-866-236-4076

or quality@sanis.com

This leaflet was prepared by: Sanis Health Inc.

1 President’s Choice Circle Brampton, Ontario

L6Y 5S5

Date of revision: June 29, 2017

Compounded Finasteride/Minoxidil 1 mg/3 mg Capsule: Important Patient InformationProvided by the Get Gambit Health Team

What is the Compounded Finasteride/Minoxidil Capsule?

The Compounded Finasteride/Minoxidil 1 mg/3 mg capsule is an innovative oral medication for treating male pattern hair loss (androgenetic alopecia). It combines two proven treatments, Finasteride and Minoxidil, into a single daily capsule, offering the convenience of dual therapy to combat hair loss and stimulate hair regrowth.

This unique combination targets the root causes of hair loss, making it a powerful option for men seeking effective, long-term results.

How Does the Compounded Finasteride/Minoxidil Capsule Work?

The capsule works through the synergistic effects of its two active ingredients:

Finasteride (1 mg):
Inhibits 5-alpha reductase, an enzyme that converts testosterone into dihydrotestosterone (DHT).
Reduces DHT levels, protecting hair follicles from miniaturization and slowing hair loss.
Minoxidil (3 mg):
Enhances blood flow to hair follicles, providing essential nutrients and oxygen.
Stimulates the growth of thicker, stronger hair in areas of thinning.

Together, these mechanisms help slow hair loss, promote regrowth, and improve hair density.

Clinical Benefits

For Hair Loss:

Dual Action Treatment: Targets both hormonal and circulatory factors contributing to hair loss.
Reduces Hair Thinning: Slows or stops the progression of male pattern baldness.
Stimulates Hair Regrowth: Encourages the development of thicker, healthier hair.
Improves Scalp Coverage: Enhances overall hair density and appearance.

For Confidence and Convenience:

Restores Confidence: Helps men feel more secure about their appearance.
Simplifies Treatment: Combines two effective therapies into one convenient daily capsule.

Dosing and Administration

How It’s Taken:
Take one capsule orally once daily, with or without food.
Consistency is essential—take the capsule at the same time each day for optimal results.
Missed Dose:
If you miss a dose, take it as soon as you remember. Do not take an extra dose to make up for the missed one.

Storage

Store the medication at room temperature, between 20–25°C (68–77°F).
Keep the capsules in their original container, away from moisture, heat, and direct sunlight.
Keep out of reach of children and pets.

Possible Side Effects

While the compounded capsule is generally well-tolerated, some individuals may experience side effects. Contact your healthcare provider if you experience any of the following:

Common Side Effects:

Decreased libido (due to finasteride).
Difficulty achieving or maintaining an erection (due to finasteride).
Dizziness or headaches (due to minoxidil).

Rare Side Effects:

Breast tenderness or enlargement (gynecomastia).
Rash, itching, or swelling.
Rapid heartbeat or chest pain (due to minoxidil).

If you notice severe side effects or symptoms of an allergic reaction, such as difficulty breathing or swelling, seek immediate medical attention.

Frequently Asked Questions (FAQ)

Who can use the Compounded Finasteride/Minoxidil Capsule?
This treatment is prescribed for men experiencing male pattern hair loss. It is not recommended for women or children.
How long does it take to see results?
Improvements in hair growth may be noticeable after 3–6 months of consistent use, with full benefits typically achieved within 12 months.
What happens if I stop taking the capsules?
If you stop taking the medication, any hair regrowth achieved during treatment may gradually be lost within 12 months. Continued use is necessary to maintain results.
Are there any contraindications for this medication?
Men with severe cardiovascular conditions or allergies to either finasteride or minoxidil should consult their healthcare provider before starting this treatment.
Can women use this medication?
No, this treatment is not approved for use in women and can cause serious birth defects if taken during pregnancy.
Is the compounded capsule covered by insurance?
Coverage for compounded medications varies. The Get Gambit Health Team can assist in verifying benefits and exploring cost-saving options.
Can this be combined with other treatments for hair loss?
This capsule provides comprehensive treatment, but it may be combined with other therapies, such as PRP (platelet-rich plasma) or low-level laser therapy, under the guidance of your healthcare provider.

Contact the Get Gambit Health Team

For more information about the Compounded Finasteride/Minoxidil 1 mg/3 mg Capsule or to determine if it’s the right treatment for you, contact us anytime:

Email: support@getgambit.ca
Phone: +1 (519) 715-8997

Let us help you restore your confidence and achieve your hair health goals with personalized care!

PART III: CONSUMER INFORMATION

^PrJAMP DUTASTERIDE

dutasteride capsules

This leaflet is part III of a three-part “Product Monograph” published when JAMP DUTASTERIDE was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about JAMP DUTASTERIDE. Contact your doctor or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

JAMP DUTASTERIDE is used alone (monotherapy) in the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostates.

JAMP DUTASTERIDE is also used in combination with the alpha blocker, tamsulosin, in the treatment of moderate to severe symptomatic BPH in men with enlarged prostates.

Combination therapy was also shown to be better than tamsulosin, but not dutasteride at reducing the risk of acute urinary retention (or where patient suddenly cannot urinate at all) and/or the need for BPH related surgery.

JAMP DUTASTERIDE is not approved for use in the prevention of prostate cancer.

What it does:

Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). JAMP DUTASTERIDE belongs to a group of medicines called 5 alpha-reductase enzyme inhibitors. JAMP DUTASTERIDE lowers DHT production in the body, leading to a shrinkage of the enlarged prostate in most men, which leads to improvements in BPH symptoms and improved urinary flow, reduced risk of acute urinary retention (or where patient suddenly cannot urinate at all), and reduced risk of the need for BPH related surgery.

JAMP DUTASTERIDE is also used with another medicine called tamsulosin, an alpha blocker, which acts by relaxing smooth muscle in the prostate and bladder neck at the site of obstruction, resulting in improvements in BPH symptoms and improved urinary flow.

Symptoms of BPH may be seen to improve after 3 months of treatment with JAMP DUTASTERIDE, however, it may take up to 6 months to know if treatment with JAMP DUTASTERIDE will be beneficial.

When it should not be used:

Women and children should never take JAMP
Do not take JAMP DUTASTERIDE if you are allergic to dutasteride or other alpha-reductase inhibitors or any of the other ingredients of JAMP DUTASTERIDE.

What the medicinal ingredient is:

dutasteride

What the important nonmedicinal ingredients are: Nonmedicinal ingredients in your medicine include gelatin (from certified, BSE-free, non-porcine sources), glycerin, iron oxide yellow, lecithin, medium chain triglycerides, purified water, titanium dioxide. The capsules are printed with edible black ink containing iron oxide black as the colourant, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac.

Each capsule for oral administration contains 0.5 mg of dutasteride dissolved in a mixture of butylated hydroxytoluene and mono-and di-glycerides of caprilic/capric acids.

What dosage forms it comes in:

Soft gelatin capsules. Each capsule contains 0.5 mg of dutasteride.

WARNINGS AND PRECAUTIONS

Heart failure (the heart does not pump blood as well as it should) was reported more often in patients taking JAMP DUTASTERIDE and an alpha-blocker, tamsulosin, in clinical studies than in patients taking JAMP DUTASTERIDE . It is not known if taking JAMP DUTASTERIDE and an alpha-blocker caused heart failure.

BEFORE you use JAMP DUTASTERIDE, talk to your doctor or pharmacist if:

You have or have had liver
You have or have had prostate cancer or urinary tract disease.

What are the special precautions about MED- DUTASTERIDE?

Do not donate blood while taking MED DUTASTERIDE and for at least 6 months after you have stopped taking JAMP DUTASTERIDE in order to prevent giving JAMP DUTASTERIDE to a pregnant woman through blood transfusion.
In a clinical study of men aged 50 to 75 years with a recent negative biopsy for prostate cancer and an increased prostate specific antigen (PSA) blood test, men taking dutasteride had a serious form of prostate cancer more often than men who did not take dutasteride.

You must see your doctor regularly. While taking JAMP DUTASTERIDE, you must have regular checkups, including digital rectal examination and PSA examination. Follow your doctor’s advice about when to have these checkups.

Checking for prostate cancer

A man can have BPH and prostate cancer at the same time. Prior to treatment with JAMP DUTASTERIDE, you should have a thorough urological evaluation to determine the severity of your condition, and to rule out the need for immediate surgery or the possibility of prostate cancer.

About Prostate Specific Antigen (PSA)

If a doctor asks you to have a Prostate Specific Antigen (PSA) test which is used for screening prostate cancer, you should tell your doctor that you are taking JAMP DUTASTERIDE. JAMP DUTASTERIDE can lower the PSA test result. A low PSA level may give you a false sense of security about your risk for prostate cancer. Your doctor is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels while on treatment with JAMP DUTASTERIDE (even if the PSA levels are in the normal range) should be evaluated by your doctor.

INTERACTIONS WITH THIS MEDICATION

Interactions with other medicines

Some medicines can react with JAMP DUTASTERIDE and may make it more likely that you will have side effects. Some of these medicines may include:

Verapamil or diltiazem (for high blood pressure).
Ritonavir (for HIV).
Ketaconazole (for fungal infections).
Ciprofloxacin or troleandomycin (for bacterial infections).
Cimetidine (for heart burn).
Certain herbal medicines such as John’s Wort or Milk Thistle.

Make sure your doctor knows if you are taking any of these, or other medicines. Your dose of JAMP DUTASTERIDE may need to be reduced. Remember to include all medicines, herbal remedies or dietary supplements, such as vitamins, iron or calcium, which you have bought yourself without a prescription.

Do not eat grapefruit or drink grapefruit juice while taking JAMP DUTASTERIDE. This drink is known to increase the blood levels of some drugs in the body.

PROPER USE OF THIS MEDICATION

Always take JAMP DUTASTERIDE exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Usual dose:Monotherapy: One JAMP DUTASTERIDE 0.5 mg capsule once a day.

Combination therapy: One JAMP DUTASTERIDE 0.5 mg capsule once a day with one tamsulosin 0.4 mg once a day.

Swallow the capsule DO NOT chew or open the capsules. Contact with the contents of the capsules may make your mouth or throat sore.
The capsules can be taken with or without

Do not share your medication with others.

Overdose:

Missed Dose:

If you miss a dose, you can just take the next scheduled dose. Don’t take any extra capsules to make up for doses you forgot to take.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effects of dutasteride , taken alone or in combination with tamsulosin, are not being able to achieve or maintain an erection* (impotence), decrease in libido* (decreased desire to have sex or a reduced sex drive), changes or problems with ejaculations* (including a decrease in amount of semen released during sex) and breast swelling or tenderness.

If breasts swelling or tenderness becomes troublesome, or if you notice breast lumps or nipple discharge, you should talk to your doctor about these changes. Additionally, some people may experience dizziness when taking JAMP DUTASTERIDE with tamsulosin.

Rare side effects (may affect up to 1 in 1,000 people) of hair loss (usually from the body) or abnormal hair growth have been reported.

Very rare side effects (1 in 10,000 people) of allergic reactions and depressed mood and pain and swelling in the testicles have been reported.

Breast cancer has been reported in patients taking dutasteride however, the relationship between long-term use of dutasteride and breast cancer is not known.

*In a small number of people some of these events may continue after you stop taking dutasteride.

pharmacist for replacement.

Return any unused capsules to a

If you notice these side effects and any other side effects not mentioned in this leaflet, tell your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking JAMP DUTASTERIDE, contact your doctor or pharmacist.

HOW TO STORE IT

Store JAMP DUTASTERIDE capsules between 15°C and 30°C.
Keep out of the reach and sight of
Return any cracked or leaking capsules to your

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

JAMP Pharma Corporation 1310 rue Nobel Boucherville, Québec

J4B 5H3

JAMP Pharma Corporation at:

1-866-399-9091

This leaflet was prepared by JAMP Pharma Corporation Date of Revision: January 22, 2019.

IMPORTANT: PLEASE READPART III: CONSUMER INFORMATION

Minoxidil Topical 5% Solution

Minoxidil Solution 20 mg/ml (5%w/v)

This leaflet is part III of a three-part “Product monograph” published when Minoxidil Topical 5% solution was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about Minoxidil Topical 5% solution. Contact your doctor or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

Minoxidil Topical 5% solution is used for the treatment of male pattern baldness (androgenetic alopecia) on the top of the scalp (vertex) in men aged 18-65 years. It prevents further hair loss and helps hair re-growth.

Minoxidil Topical 5% solution has no effect on receding hairlines. It does not permanently reverse male pattern baldness; most new hair is lost within three to four months after stopping the medication.

What it does:

Minoxidil Topical 5% solution contains minoxidil, which is thought to work by aiding the blood flow to hair follicles on your scalp and thereby helping hair re-growth. Initial hair re-growth may look soft, downy (“vellus”) hair and may be barely visible. After further treatment, hair re-growth may change and become the same colour and thickness as the rest of the hair.

Minoxidil Topical 5% solution is more effective if you are experiencing gradually thinning hair or gradual hair loss on the top of the head (as shown in the image).

Gradual hair loss on the top of the scalp

Male Pattern Baldness or Hereditary Hair Loss is recognizable because:

Of the pattern of hair loss (see diagrams above).
Hair loss starts gradually and
You have a family history of hair
No other symptoms are present with your hair

You must use Minoxidil Topical 5% solution for at least 4 months, and possibly for up to 1 year, before you see any effect.

The amount of hair regrowth is different for each person. Not everyone will respond to Minoxidil Topical 5% solution. The response to this medicine cannot be predicted. No one will be able to grow back all of their hair.

You may respond better if you have been losing your hair for a shorter period of time (less than 10 years) or have little initial hair loss (less than a diameter of 10 cm).

When it should not be used:

Do not use this medicine if you:

are female
have an allergic reaction (hypersensitivity) to minoxidil or any of the other ingredients in Minoxidil Topical 5% solution
have treated or untreated high blood pressure
have baldness not due to male pattern baldness
have any condition that affects your scalp such as redness, inflammation, irritation, pain on touching, sunburn, or psoriasis
have a shaved scalp or broken skin on the scalp
are treated with any kind of dressing or bandage (occlusive dressing) or other topical medication (e.g. anthralin, tretinoin or corticosteroids) on your scalp for any skin scalp problems
have temporary hair loss as a result of taking certain medications (cancer chemotherapy) or having certain disease state or nutritional problems, as well as poor grooming habits.
have secondary syphilis

What the medicinal ingredient is: minoxidil What the important non-medicinal ingredients are: alcohol and propylene glycol

What dosage forms it comes in: Minoxidil Topical 5% solution comes with pump-spray and child resistant dropper applicators.

WARNINGS AND PRECAUTIONS

Apply Minoxidil Topical 5% solution only on the scalp.
Avoid contact with eyes as Minoxidil Topical 5% solution contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas. If contact occurs, rinse thoroughly with large amounts of Stop use and speak to your doctor if irritation persists.
Minoxidil Topical 5% solution may rarely cause low blood pressure, salt and water retention that lead to chest pain (angina), rapid heartbeat (tachycardia), swollen hands and feet
May change colour/texture of hair
Minoxidil Topical 5% solution should not be used when there is no family history of hair loss, hair loss is sudden and/or patchy, or the reason for hair loss is unknown
Shedding of hair may occur within two to six weeks after using the product. If shedding persists for more than two weeks, users should stop applying Minoxidil Topical 5% solution and consult their doctor.

Minoxidil Topical 5% solution should not be used in males under 18 or over 65 years of age.

Before using Minoxidil Topical 5% solution, talk to your doctor or pharmacist if any of the following conditions applies to you:

High or low blood pressure or heart disease or irregular heartbeat (arrhythmia).
Under other treatment for any scalp

Before using Minoxidil Topical 5% solution talk to your pharmacist or doctor if you are taking or have recently taken prescription drugs, non-prescription drugs or natural health product

The following medications may increase the absorption of minoxidil:

Anthralin – used to treat psoriasis
Tretinoin – used to treat acne or other skin conditions

(Minoxidil) also may increase the effect of hydralazine (drug to treat high blood pressure).

PROPER USE OF THIS MEDICATION

Application:

Minoxidil Topical 5% solution is for topical and external use It should only be applied directly to the scalp area. Make sure your hair and scalp are completely dry before applying the solution.
Shampooing is not required before applying Minoxidil Topical 5% solution. However, if you wash your scalp before applying Minoxidil Topical 5% solution, use a mild shampoo. Dry hair and scalp before application.
Do not apply to areas of the body other than the scalp.
Do not apply Minoxidil Topical 5% solution, to a sunburned or irritated,

broken or shaved scalp.

For to work best, you should allow Minoxidil Topical 5% solution to remain on the scalp for at least 4
Wash your hands thoroughly before and after applying the solution and rinse other areas that have come into contact with the
Please see special instructions below for 2 different applicators. Each applicator contains one dose of medicine.
If you are planning to be in the sun after applying Minoxidil Topical 5% solution, use headwear. Do not use sunscreens or sun-blocking agents.
Avoid swimming, showering or physical activity involving excessive sweating or wetting in rain for at least 4 hours after
To minimize breakage of existing hair, the scalp should be massaged Comb hair with a widely spaced, round tooth comb to avoid excessive pulling.
There is no need to change your usual hair care routine when using Minoxidil Topical 5% You may use hair sprays, mousses, conditioners, gels, etc. However, you should apply Minoxidil Topical 5% solution first and wait for it to dry before applying your styling aids.
It is not known if hair colouring, perming or relaxing agents change the effect of Minoxidil Topical 5% solution. However, to avoid possible scalp irritation, you should make sure all of the Minoxidil Topical 5% solution has been washed off the hair and scalp before using these products.

Usual dose:

1 ml applied twice daily to the scalp, beginning at the centre of the affected area; for example, once in the morning and once at night. Do not exceed 2 ml in a day. Exceeding the recommended dosage may cause increased side effects.
If you do not see any results after 1 year, stop using Minoxidil Topical 5% solution and seek the advice of your
One bottle of Minoxidil Topical 5% solution should last for 25- 30 days, if applied twice a day according to

Missed dose:

If a dose is missed, use as soon as remembered if it is within a few hours of the usual time applied. Do not apply if it is almost time for the next If a dose is missed, the amount used in the next dose should not be doubled.

Overdose:

INSTRUCTIONS FOR USE OF APPLICATORS APPLICATOR OPTIONS

Hair styles and degree of hair loss can be very different for each person. We have included 2 applicators that have been designed especially for men. You can choose whichever one works best for you.

Pump-Spray Applicator
Child-Resistant Dropper

USING THE APPLICATORS

Pump-Spray Applicator

Works best for applying Minoxidil Topical 5% solution to large areas of the scalp.

Remove large outer cap and keep
Remove inner Child-Resistant cap by

pushing down while turning the cap anti-clockwise. Retain Child-Resistant cap.

Insert the pump-spray applicator into the bottle and screw on tightly.
After aiming the pump at the centre of the thinning or bald area of the scalp, press the pump once and spread Minoxidil Topical 5% solution with fingertips to cover all the thinning or bald Repeat for a total of 6 squirts, to apply a total dose of 1 mL. Avoid breathing spray mist.
To retain Child-Resistant feature, remove Pump-Spray applicator and retain for next application. Replace Child-Resistant cap by tightly screwing on in a clockwise direction.
Child Resistant Dropper

Works best for applying Minoxidil Topical 5% solution to small areas of the scalp or under hair.

Remove large outer cap and keep
Remove inner Child-Resistant cap by pushing down while turning the cap anti-clockwise. Throw this cap
Squeeze the rubber bulb and insert the dropper into the bottle.
Release the bulb, allowing the dropper to fill to the 1 mL If the level of the solution is above the 1 mL level, squeeze the extra amount back into the bottle.
Place the tip near the part of the scalp you want to treat and gently squeeze the bulb to gradually release the solution. To prevent the solution from running off the scalp, apply a small amount at a
Replace the dropper in the bottle and screw on tightly.
Replace large outer cap over the dropper applicator when not in use.
For future use, the dropper can be removed by pushing down while turning the dropper cap anti-clockwise.

Minoxidil Topical 5% solution may cause side-effects.

If you experience any of the following, stop using the medicine and tell your doctor.

Low or high blood
Chest
Rapid
Faintness or dizziness
Sudden unexplained weight
Swollen hands or
Persistent local redness or
Muscle
Shortness of breath or difficulty

Other side effects include:

Unwanted non-scalp This may be due to the frequent applying of Minoxidil Topical 5% solution on areas of the skin other than the scalp.
Scalp irritation such as local redness, itchiness, dryness, flaky skin have all been reported. This is usually only a temporary effect, but if it is persistent you should stop using this product.
Temporary hair loss may occur during the first 2-6 weeks of use. If this hair loss continues for longer than 2 weeks, stop using the product and talk to your doctor.
Change in hair colour and/or texture may occur. If this happens you should stop using Minoxidil Topical 5% solution.
Minoxidil Topical 5% solution should be applied only to the The risk of side effects may be greater when it is applied to other parts of the body.

This is not a complete list of side effects. For any unexpected effects while using Minoxidil Topical 5% solution contact your doctor or pharmacist.

Keep out of the reach and sight of
Store at a controlled temperature range of 15- 30°C, in an upright position.
Do not use after the expiry date
Ask your pharmacist how to dispose of medicines no longer required.

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Johnson & Johnson Inc. toll-free telephone number 1-800 (1-800-764-2463) between 8:15 a.m.

and 4:45 p.m. Eastern Time.

©Johnson & Johnson Inc.2016 Last revised 5 January 2016.-

IMPORTANT: PLEASE READ

PART III: CONSUMER INFORMATION Men’s FOAM 5%

Minoxidil Foam 5% (50 mg/g)

This leaflet is part III of a three-part “Product monograph” published when Men’s FOAM 5% was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about Men’s FOAM 5%. Contact your doctor or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

Men’s FOAM 5% is used for the treatment of male pattern baldness (androgenetic alopecia) on the top of the scalp (vertex) in men aged 18-65 years. It prevents further hair loss and helps hair re-growth on the top of scalp (vertex only, as shown below) may be barely visible. After further treatment, hair re-growth may change and become the same colour and thickness as the rest of the hair.

Men’s FOAM 5% is more effective if you are experiencing gradually thinning hair or gradual hair loss on the top of the head (as shown in the image below).

Gradual hair loss on the top of the scalp

Male Pattern Baldness or Hereditary Hair Loss is recognizable because:

Of the pattern of hair loss (see diagrams above).
Hair loss starts gradually and
You have a family history of hair
No other symptoms are present with your hair

You must use Men’s FOAM 5% usually for at least 4 months before you see any results.

The amount of hair regrowth is different for each person. Not everyone will respond to Men’s FOAM 5%. The response to this medicine cannot be predicted. No one will be able to grow back all of their hair.

You may respond better if you have been losing your hair for a shorter period of time (less than 10 years) or have little initial hair loss (less than a diameter of 10 cm).

When it should not be used:

Men’s FOAM 5% has no effect on receding hairlines. It does not permanently reverse male pattern baldness; continued use is needed as most new hair is lost within three to four months after stopping the medication.

What it does:

Men’s FOAM 5% contains minoxidil, which is thought to work by aiding the blood flow to hair follicles on your scalp and thereby helping hair re-growth. Initial hair re- growth may look soft, downy (“vellus”) hair and

Do not use this medicine if you:

are female
are a male under 18 or over 65 years of age
have no family history of hair loss, hair loss is sudden and /or patchy, or the reason for hair loss is unknown
have an allergic reaction (hypersensitivity) to minoxidil or any of the other ingredients in Men’s FOAM 5%
have treated or untreated high blood pressure
have baldness not due to male pattern baldness
have any condition that affects your scalp such as redness, inflammation, irritation, pain on touching, sunburn, or psoriasis
have a shaved scalp or broken skin on the scalp
are treated with any kind of dressing or bandage (occlusive dressing) or other topical medication (e.g. anthralin, tretinoin or corticosteroids) on your scalp for any skin scalp problems
have temporary hair loss as a result of taking certain medications (cancer chemotherapy) or having certain disease state or nutritional problems, as well as poor grooming habits.
have secondary syphilis

What the medicinal ingredient is: minoxidil What the important non-medicinal ingredients are: butylhydroxytoluene (BHT), stearyl alcohol, cetyl alcohol, alcohol SD 40B, lactic acid, citric acid anhydrous, glycerol anhydrous, polysorbate 60, propellant Aeropin 70 (propane, butane, iso-butane), purified water

What dosage forms it comes in:

Men’s FOAM 5% is foam that contains 50 mg minoxidil per gram and is delivered from a pressurized container.

WARNINGS AND PRECAUTIONS

Before using Men’s FOAM 5%, talk to your doctor or pharmacist if any of the following conditions applies to you:

High or low blood pressure or heart disease or irregular heartbeat (arrhythmia).
Under other treatment for any scalp
Apply Men’s FOAM 5% only on the scalp.
Avoid contact with eyes as Men’s FOAM 5% contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas. If contact occurs, rinse thoroughly, with large amounts of Stop use and speak to your doctor if irritation persists.
Men’s FOAM 5% may cause local skin reactions (contact dermatitis), irritation to the eyes or mucous
May change colour/texture of hair
Avoid inhalation of the
Men’s FOAM 5% may rarely cause low blood pressure, salt and water retention that lead to chest pain (angina), rapid heartbeat (tachycardia), swollen hands and feet
Shedding of hair may occur within two to six weeks after using the product. If shedding persists for more than two weeks, users should stop applying Men’s FOAM 5% and consult their doctor.
If you do not see any results after 4 months, stop using Men’s FOAM 5% and seek advice of your doctor.

Before using Men’s FOAM 5% talk to your pharmacist or doctor if you are taking or have recently taken prescription drugs, non- prescription drugs or natural health products.

The following medications may increase the absorption of minoxidil:

Anthralin – used to treat psoriasis
Tretinoin – used to treat acne or other skin conditions

(Minoxidil) also may increase the effect of hydralazine (drug to treat high blood pressure).

PROPER USE OF THIS MEDICATION

Men’s FOAM 5% is for topical and external use only. It should only be applied directly to the scalp area. Make sure your hair and scalp are completely dry before applying the foam.

Pre-Application:

Shampooing is not required before applying Men’s FOAM 5%. However, if

you wash your scalp before applying Men’s FOAM 5%, use a mild shampoo. Dry hair and scalp before application.

Do not apply to areas of the body other than the scalp.
Do not apply Men’s FOAM 5%, to a sunburned or irritated, broken or shaved
Wash your hands thoroughly before and after applying the foam and rinse other areas that have come into contact with the foam.

Application:

To open container: Match arrow on can ring with arrow on cap. Pull off cap.
Hold can upside down and press nozzle to dispense half a capful of foam (equivalent to 1g) onto your fingers.
The foam may begin to melt on contact with warm skin. If your fingers are warm, rinse them in cold water Be sure to dry them thoroughly before handling the foam.
Use your fingers to apply the foam on to the scalp in the hair loss area.
The foam should be massaged lightly into the affected areas of the scalp.
For to work best, you should allow Men’s FOAM 5% to remain on the scalp for at least 4 hours.

Post Application:

Do not dry the foam with a hair
If you are planning to be in the sun after applying Men’s FOAM 5%, use headwear. Do not use sunscreens or sun- blocking agents.
Avoid swimming, showering or physical activity involving excessive sweating or wetting in rain for at least 4 hours after
To minimize breakage of existing hair, the scalp should be massaged Comb hair with a widely spaced, round tooth comb to avoid excessive pulling.
You may use hair sprays, mousses, conditioners, gels, etc. However, you should apply Men’s FOAM 5% first and wait for it to dry before applying your styling
It is not known if hair colouring, perming or relaxer agents change the effect of Men’s FOAM 5%. However, to avoid possible scalp irritation, you should make sure all of the Men’s FOAM 5% has been washed off the hair and scalp before using these products.

Usual dose:

Half (½) capful (equivalent to 1 gram of foam) applied twice daily to the entire affected area; for example, once in the morning and once at night.

Do not exceed two doses of half (½) capful (equivalent to 2 grams of foam) in a day. Exceeding the recommended dosage may cause increased side effects.

One can of Men’s FOAM 5% should last for 30 days (one month), if applied twice a day according to directions.

Missed dose:

If you miss one or two applications, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.

Overdose:

Men’s FOAM 5% may cause side- effects.

If you experience any of the following, stop using the medicine and tell your doctor.

Low or high blood
Chest
Rapid
Faintness or dizziness
Sudden unexplained weight
Swollen hands or
Persistent local redness or
Muscle
Shortness of breath or difficulty

Other side effects include:

Unwanted non-scalp hair. This may be due to the frequent applying of Men’s FOAM 5% on areas of the skin other than the
Scalp irritation such as local redness, itchiness, dryness, flaky skin have all been reported. This is usually only a temporary effect, but if it is persistent you should stop using this product.
Temporary hair loss may occur during the first 2-6 weeks of use. If this hair loss continues for longer than 2 weeks, stop using the product and talk to your doctor.
Change in hair colour and/or texture may occur. If this happens you should stop using Men’s Foam 5%.
Men’s Foam 5% should be applied only to the scalp. The risk of side effects may be greater when it is applied to other parts of the body.

This is not a complete list of side effects. For any unexpected effects while using Men’s FOAM 5% contact your doctor or pharmacist.

Keep out of the reach and sight of
Store at a controlled temperature range of 15- 30°C, in an upright position.
Do not use after the expiry date on the base of the can.
The product in this pressurized container is extremely flammable, therefore exposure of the container or its contents to open flames should be avoided.
Protect from sunlight and do not expose to temperatures above 50°C.
Do not pierce or burn the container, even when empty.
Do not use while
Do not use near, or place container on, polished or painted surfaces.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Johnson & Johnson Inc. toll-free telephone number 1-800 (1-800-764-2463) between 8:15 a.m.

and 4:45 p.m. Eastern Time.

©Johnson & Johnson Inc.2016 Last revised April 12, 2017

PART III: CONSUMER INFORMATION

^PrFINASTERIDE

Finasteride Tablets, House Standard

This leaflet is part Ill of a three-part “Product Monograph” published when FINASTERIDE was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about FINASTERIDE. Contact your physician or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION FINASTERIDE IS FOR USE BY MEN ONLY.

What the medication is used for

FINASTERIDE is used for the treatment of male pattern hair loss (also known as androgenetic alopecia).

What it does

FINASTERIDE blocks an important enzyme (Type II

5-alpha-reductase) involved in the regulation of the hair follicle and lowers the levels of dihydrotestosterone (DHT) in the scalp, a major cause of male pattern hair loss.

When it should not be used

Do not take FINASTERIDE if you think you are allergic to any of its ingredients.

Women and children should not take FINASTERIDE. Do not take FINASTERIDE if you are or may potentially be pregnant (see WARNINGS AND PRECAUTIONS, Pregnancy).

What the medicinal ingredient is

Finasteride

What the non-medicinal ingredients are

Docusate sodium, Hydroxypropyl Cellulose, Hypromellose, Iron Oxide Red, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Talc, Titanium Dioxide and Yellow Iron Oxide.

What dosage form it comes in Tablets (film-coated): 1 mg

WARNINGS AND PRECAUTIONS

BEFORE you use FINASTERIDE talk to your physician or pharmacist about any medical problems you have or have had, especially liver disease, and about any allergies.

Finasteride 5 mg (5 times the dose of FINASTERIDE for treatment of male pattern hair loss) may increase the chance of a more serious form of prostate cancer.

Pregnancy

Women who are or may potentially be pregnant must not use FINASTERIDE. They should also not handle crushed or broken tablets of FINASTERIDE. If the active ingredient in FINASTERIDE is absorbed after oral use or through the skin by a woman who is pregnant with a male baby, it may cause the male baby to be born with abnormalities of the sex organs.

FINASTERIDE tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed. If a woman who is pregnant comes into contact with the active ingredient in FINASTERIDE, a physician should be consulted.

INTERACTIONS WITH THIS MEDICATION

FINASTERIDE usually does not interfere with other medicines. However, you should always tell your physician about all medicines you are taking or plan to take, including those obtained without prescription.

FINASTERIDE can affect a blood test called PSA (prostate- specific antigen) used for the screening of prostate cancer. If you have a PSA test done, you should tell your physician that you are taking FINASTERIDE.

PROPER USE OF THIS MEDICATION

Take FINASTERIDE as your physician has prescribed.

Usual dose

Take one tablet of FINASTERIDE every day, with or without food.

Missed Dose

If you miss a dose, do not take an extra one. Just take the next tablet as usual.

Overdose

When can I expect to see results from using FINASTERIDE?

Male pattern hair loss is a condition that develops over a long period of time. On average, healthy hair grows only about 1 cm each month. Therefore, it will take time to see any effect. In general, daily use for three months or more may be necessary before you notice that hair growth is increased, or further hair loss is prevented.

How long do I need to use FINASTERIDE?

FINASTERIDE can only work over the long-term if you continue taking it.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like any medicine, FINASTERIDE may cause side effects. Common side effects:

less desire to have sex;
difficulty in achieving an erection;
problems with ejaculation, such as a decrease in the amount of semen released during sex (this does not appear to interfere with normal sexual function).

In clinical studies, these side effects disappeared in men who stopped taking FINASTERIDE and in most men who continued treatment.

In general use, the following have been reported infrequently:

breast enlargement (swelling) and/or tenderness;
depression;
decrease in sex drive that continued after stopping the medication;
allergic reactions including rash, itching, hives, and swelling of the lips, tongue, throat and face;
muscle injury, muscle pain, muscle weakness, abnormal test results (CK elevation);
problems with ejaculation that continued after stopping the medication;
testicular pain;
blood in semen
difficulty in achieving an erection that continued after stopping the medication;
male infertility and/or poor quality of Improvement in the quality of semen has been reported after stopping the medication;
male breast cancer;
changes in mood, which can include suicidal

Talk to your doctor about any changes in your breast such as lumps, pain or nipple discharge. Tell your physician or pharmacist promptly about these or any other unusual symptoms.

This is not a complete list of side effects. For any unexpected effects while taking FINASTERIDE, contact your physician or pharmacist.

HOW TO STORE IT

Store between 15°C and 30°C and protect from light. Keep blister in the outer carton until all tablets are used.

KEEP FINASTERIDE AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.

MORE INFORMATION

If you want more information about FINASTERIDE:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https:/canada.ca/en/health-canada.html), or by contacting the sponsor Sanis Health Inc. at:

1-866-236-4076

or quality@sanis.com

This leaflet was prepared by: Sanis Health Inc.

1 President’s Choice Circle Brampton, Ontario

L6Y 5S5

Last revised: June 1, 2020

IMPORTANT SAFETY INFORMATION FOR TESTOSTERONE CYPIONATE INJECTION

What it does:

DEPO-TESTOSTERONE delivers testosterone into the bloodstream through an injection into your gluteal muscle. DEPOTESTOSTERONE helps raise your testosterone to normal levels.

When it should not be used:

if you have prostate or breast cancer (confirmed or suspected by your doctor)
if you have difficulty in urinating due to an enlarged prostate
if you have a known allergy or sensitivities to any of the ingredients contained in DEPO-TESTOSTERONE, including testosterone USP that is chemically synthesized from soy (see “What the medicinal and nonmedicinal ingredients are” in this section).

DEPO-TESTOSTERONE should NOT be used by women. Pregnant and breast-feeding women are especially at risk. Testosterone may cause harm to your unborn baby.

What the medicinal ingredient is:

Testosterone cypionate

What the nonmedicinal ingredients are:

Benzyl alcohol, benzyl benzoate, and cottonseed oil

What dosage forms it comes in:

DEPO-TESTOSTERONE is available in one strength, 100 mg

testosterone cypionate /mL.

DEPO-TESTOSTERONE is available in the following packaging:

100 mg per mL – In vials of 10 mL.

WARNINGS AND PRECAUTIONS

There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.

DEPO-TESTOSTERONE is not recommended for use in children < 18 years of age.

DEPO-TESTOSTERONE can cause changes in your vision. It is called chorioretinopathy.

You should not use testosterone in an attempt to reduce weight and increase muscle, or improve athletic performance as it may cause serious health problems.

You should not use testosterone to treat sexual dysfunction or male infertility.

DEPO-TESTOSTERONE contains benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome” (difficulty in catching breath, low blood pressure, slow heart rate), and death in pediatric patients. Premature and low-birth weight infants may be more likely to develop toxicity.

Pregnancy: Benzyl alcohol can cross the placenta.

Before using DEPO-TESTOSTERONE, talk to your doctor if

you:

have difficulty urinating due to an enlarged prostate.

Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;

have prostate cancer (confirmed or suspected);
have liver, kidney or heart disease;
have high blood pressure (hypertension);
have diabetes;
have breathing problems during sleep (sleep apnea);
have heart or blood vessels problems or a history of these problems such as heart attack, stroke, or blood clots in the lungs or the legs.

Drug Abuse and Dependence: DEPO-TESTOSTERONE contains testosterone. Testosterone is a controlled substance because some people take it in high doses (abuse it), even if their body is making enough testosterone. Taking too much (abusing) testosterone can cause serious health problems, which can even lead to death (see Overdose).

Individuals who have abused testosterone may experience withdrawal symptoms lasting for weeks or months which include, but are not limited to: changes in mood, and appetite, as well as fatigue, insomnia, decreased sex drive and loss of function of the testes and ovaries.

Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription.

Drugs that include:

Insulin
Corticosteroids
Propranolol
Warfarin

PROPER USE OF THIS MEDICATION

DEPO-TESTOSTERONE should only be administered by a health care professional.

When you are given DEPO-TESTOSTERONE, your blood testosterone should be checked on a regular basis.

Usual dose: 200 mg is given intramuscularly (in the muscle) every two weeks.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. Taking too much (abusing) testosterone for a long time can cause serious health problems, which can even lead to death. Some of the health problems include effects on the cardiovascular system, reproductive system and the liver, as well as serious psychiatric problems.

Missed Dose:

If you have missed a dose of DEPO-TESTOSTERONE, you should contact your doctor to schedule your next injection.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, DEPO-TESTOSTERONE can have side effects. The following side effects have been reported for testosterone products:

skin irritation or redness or rash at the application site;
increased prostatic specific antigen (PSA);
enlarged prostate (benign prostatic hyperplasia);
an increase in red blood cell count, (hematocrit and

hemoglobin);

acne;
change in mood, depression;
prolonged or painful erection;
sleep disturbances caused by breathing problems;
aggression or aggressive behaviour;
breast enlargement and breast pain;
loss of hair and baldness;
high blood pressure;
weight gain;
headache, dizziness;
increased or irregular heart rate, blood clot in the lungs or

the legs;

This is not a complete list of side effects. For any unexpected effects while taking DEPO-TESTOSTERONE, contact your doctor or pharmacist.

IMPORTANT SAFETY INFORMATION FOR TESTOSTERONE 1% GEL

What it does:

TESTOSTERONE 1% GEL delivers medicine into your bloodstream through your skin. TESTOSTERONE 1% GEL helps raise your testosterone to normal levels.

When it should not be used:

If you have or it is suspected that you have prostate or breast cancer.
If you have a known allergy to any of its components [the active ingredient is testosterone, which may be synthesized from soy; (see “What the non-medicinal ingredients are” in this section)].

TESTOSTERONE 1% GEL should NOT be used by women. Pregnant and breast-feeding women are especially at risk and should avoid skin contact with application sites on men. Testosterone may cause harm to your unborn baby. Testosterone exposure during pregnancy has been reported to be associated with fetal abnormalities. If skin contact with unwashed or unclothed application sites of men using TESTOSTERONE 1% GEL and/or with clothing or other fabrics exposed to TESTOSTERONE 1% GEL occurs, pregnant or nursing women should immediately wash the area of contact with soap and water.

What the medicinal ingredient is:

Testosterone USP

What the non-medicinal ingredients are:

Alcohol, purified water, sodium hydroxide, Carbopol 980 and isopropyl myristate.

What dosage forms it comes in:

TESTOSTERONE 1% GEL is a gel containing 1% testosterone. It is supplied either in a pump or foil packets:

One 2.5 g packet contains 25 mg of testosterone
One 5.0 g packet contains 50 mg of testosterone
One full press of the pump delivers 1.25 g of gel which contains 12.5 mg of testosterone.

WARNINGS AND PRECAUTIONS:

Serious Warnings and Precautions:

TESTOSTERONE 1% GEL can be transferred to another person when skin-to-skin contact with application site occurs.

Signs of puberty (unexpected sexual development) have been reported in children who were exposed to testosterone gel.
Keep children away from unwashed or unclothed application sites of men using TESTOSTERONE 1% GEL and from unwashed clothing or other fabrics exposed to TESTOSTERONE 1% GEL.
Men who use TESTOSTERONE 1% GEL must strictly follow the instructions for use to lower the risk of transferring TESTOSTERONE 1% GEL to another person.

You should prevent TESTOSTERONE 1% GEL from transferring to another person, especially pregnant or breast-feeding women, or children by taking the following precautions:

Children and women should avoid contact with the application sites on men using TESTOSTERONE 1% GEL.
TESTOSTERONE 1% GEL should be applied only to the areas of the shoulders, upper arms, and/or abdomen that will be covered by a short sleeve T-shirt.
Wash hands immediately with soap and water after application of TESTOSTERONE 1% GEL.
Cover the application site(s) with clothing (such as a shirt) after TESTOSTERONE 1% GEL has dried.
If direct skin-to-skin contact is anticipated, wash the application site(s) thoroughly with soap and water to remove any TESTOSTERONE 1% GEL left on the application site(s).
In the event that an unwashed or uncovered TESTOSTERONE 1% GEL application site and/or unwashed clothing or other fabrics exposed to TESTOSTERONE 1% GEL does come in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.

In children, signs of testosterone exposure can include unexpected sexual development such as inappropriate enlargement of the penis or clitoris, development of pubic hair, increased erections, or aggressive behaviour. In women, signs of testosterone exposure include changes in body hair distribution, significant increase in acne, or other signs of the development of masculine traits. Any of these changes should be brought immediately to the attention of a doctor. The possibility of exposure to testosterone should be discussed with the doctor.

TESTOSTERONE 1% GEL must not be used by children under the age of 18.

If you are suffering from severe heart, liver or kidney disease, treatment with testosterone may cause serious complications in the form of water retention in your body, sometimes accompanied by congestive heart failure (inadequate pumping of the heart with build-up of fluid in body tissues).

Testosterone may cause a rise in blood pressure. Therefore, TESTOSTERONE 1% GEL should be used with caution if you are suffering from high blood pressure.

In patients receiving long-term TESTOSTERONE 1% GEL therapy, the physician may prescribe regular blood tests, such as testosterone, complete blood count, liver function tests and lipid profile. Testosterone increases red blood cell count which theoretically could increase the risk of blood clots.

Your physician may also monitor your prostate gland for any negative effects of testosterone therapy by performing digital rectal examinations.

There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.

You should not use testosterone in an attempt to reduce weight and increase muscle, or improve athletic performance as it may cause serious health problems.

You should not use testosterone to treat sexual dysfunction or male infertility.

Before using TESTOSTERONE 1% GEL, talk to your doctor if you:

have difficulty urinating due to an enlarged prostate. Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;
have prostate cancer (confirmed or suspected);
have liver, kidney or heart disease;
have high blood pressure (hypertension);
have diabetes;
have breathing problems during sleep (sleep apnea).
have heart or blood vessel problems or a history of these problems such as heart attacks, stroke, or blood clot in the lungs or legs.

Drug Abuse and Dependence:

TESTOSTERONE 1% GEL contains testosterone, which is a controlled substance under Schedule G of the Food and Drugs Act. Reduction in testicular size (testicular atrophy), limited or complete infertility have been reported in men who abuse anabolic androgenic steroids.

Precautions while using TESTOSTERONE 1% GEL:

Following application of TESTOSTERONE 1% GEL, allow gel to dry completely before smoking or going near an open flame.

INTERACTIONS WITH THIS MEDICATION:

Be sure to tell your doctor about all other prescription and non-prescription medicines you are taking, if any. Drugs that may interact with TESTOSTERONE 1% GEL include:

insulin
corticosteroids
propranolol
anti-clotting medications (e.g., warfarin)

PROPER USE OF THIS MEDICATION:

Apply TESTOSTERONE 1% GEL at the same time each day, (preferably in the morning). Apply the proper amount of gel every morning as instructed by your doctor. The amount of testosterone you need may be adjusted by your doctor. Always follow your doctor’s recommendations.
Be sure your skin is completely dry before applying TESTOSTERONE 1% GEL. For example, if you take a bath or shower in the morning, apply TESTOSTERONE 1% GEL after your bath or shower once your skin is completely dry.
Apply TESTOSTERONE 1% GEL only to your abdomen (stomach area), shoulders, and/or upper arms, as shown in the following diagram.

o Use a circular motion to rub in the gel for several seconds. Applying TESTOSTERONE 1% GEL only to the areas shown helps ensure that your body will absorb the right amount of testosterone. TESTOSTERONE 1% GEL may be applied to the same areas of the body each day. It is not necessary to alternate application sites.

o Never apply TESTOSTERONE 1% GEL to your genitals (penis and scrotum) or to damaged skin.

o Apply TESTOSTERONE 1% GEL only to healthy, normal skin. Avoid skin with open sores, wounds, sunburn, or irritation.

Following application of TESTOSTERONE 1% GEL, allow gel to dry completely before smoking or going near an open flame.
Wash your hands immediately following application.

o It is important to wash your hands with soap and water right away to reduce the chance that any TESTOSTERONE 1% GEL will spread from your hands to other people.

o If, however, you expect direct skin contact with someone else, you should wash your application site(s) with soap and water before that encounter. This will reduce the chance that any TESTOSTERONE 1% GEL will transfer to the other person.

Let TESTOSTERONE 1% GEL dry for a few minutes before you dress.

o This prevents your clothing from absorbing or wiping the gel off your skin, ensuring that your body will absorb the correct amount of testosterone.

o Wait 5 to 6 hours before showering or swimming. To ensure that TESTOSTERONE 1% GEL is fully absorbed into your system, you should generally wait five to six hours after application before showering or swimming. However, once in a while you may shower or swim as soon as one hour after applying TESTOSTERONE 1% GEL. Although this is not recommended, if done infrequently, it will have little effect on the overall amount of TESTOSTERONE 1% GEL that is absorbed by your body.

o Transference of TESTOSTERONE 1% GEL to another person can be completely prevented when the application site is covered with a long-sleeved shirt (cotton-polyester blend).

It is important that you read and follow the directions below on how to use TESTOSTERONE 1% GEL properly:

Using the TESTOSTERONE 1% GEL packet:

Opening the packet:

Open one TESTOSTERONE 1% GEL aluminum foil packet by folding it along the top edge and carefully tearing it open.

Applying TESTOSTERONE 1% GEL to your skin:

o Gently squeeze the gel from the bottom of the packet toward the top.

o Squeeze out half (1/2) of the contents of the packet and apply it to the areas of your body shown in the diagram. Use a circular motion to rub in the gel for several seconds. Once you have applied this first half to your skin, squeeze out the second half and apply it in the same manner. Discard the empty packet in the household trash in a manner that prevents accidental application or ingestion by household members, especially nursing/pregnant women and children.

What should I do if I get TESTOSTERONE 1% GEL in my eyes?

If you get TESTOSTERONE 1% GEL in your eyes, rinse your eyes right away with warm clean water to flush out any TESTOSTERONE 1% GEL. Seek medical attention if discomfort persists.

Missed Dose:

If you miss a dose, do not double your next dose the next day to catch up. If your next dose is less than 12 hours away, it is best to wait. Do not take the skipped dose. If it is more than 12 hours until your next dose, take the dose that you missed. Resume your normal dosing the next day.

Overdose:

Contact your doctor or pharmacist or poison control centre immediately if you suspect an overdose.

If you use more TESTOSTERONE 1% GEL than the recommended dose (an overdose), wash the skin with soap and water where TESTOSTERONE 1% GEL was applied and contact your doctor or pharmacist .

What to do if someone is exposed to the medication:

If someone else is exposed to TESTOSTERONE 1% GEL either by direct contact with the gel itself or indirectly because of contact with your treated skin, that person should wash his or her area of contact thoroughly with soap and water as soon as possible. The longer the gel is in contact with the skin before washing, the greater is the chance that the other person will absorb some testosterone.

This is particularly important for women, especially pregnant or nursing women, and children. Children have naturally low levels of testosterone and could be harmed by higher levels. Pregnant women are at an even higher risk because increased testosterone levels may cause harm or abnormalities in the unborn baby.

Never share your TESTOSTERONE 1% GEL with anyone.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM:

Like all medicines, TESTOSTERONE 1% GEL can have side effects. The following side effects have been reported for products containing testosterone:

Skin irritation or redness or rash at the application site;
increased prostatic specific antigen (PSA);
enlarged prostate (benign prostatic hyperplasia);
an increase in red blood cell count (hematocrit and hemoglobin);
acne;
change in mood, depression;
prolonged or painful erection;
sleep disturbances caused by breathing problems;
aggression or aggressive behaviour;
breast enlargement and breast pain;
loss of hair and baldness;
high blood pressure;
weight gain;
headache, dizziness;
increased or irregular heart rate, blood clot in the lungs or the legs.
reduction in testicular size (testicular atrophy), limited or complete infertility

Signs of puberty (unexpected sexual development) have been reported in children who were exposed to testosterone gel. See WARNINGS AND PRECAUTIONS.

Changes in body hair distribution, significant increase in acne, or other signs of the development of masculine traits in the female partner or in any person (including children) exposed to skin-to- skin contact, should be brought to the attention of a doctor.

CONTRAVE ^®

naltrexone HCl—bupropion HCl

Antiobesity agent—Weight Management Bausch Health

Date of Revision: August 21, 2023

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

Serious Warnings and Precautions

New or worsened emotional or behavioural problems:

Bupropion, one of the ingredients in CONTRAVE, is also used to treat depression. When you first start taking CONTRAVE or when your dose is adjusted, you may experience new or worsened feelings of depression, agitation, hostility, anxiety, or impulsivity.

It is important that you and your healthcare professional talk regularly during your treatment about how you are feeling.

You may find it helpful to tell a relative or close friend that you are taking this medicine to help you manage your weight. Ask them to read this leaflet. You might ask them to tell you if they are worried about changes in your behaviour.

If you experience changes in your behaviour, tell your healthcare professional right away.

Self-harm or Suicide:

Bupropion, one of the ingredients in CONTRAVE, can increase the risk of suicidal thoughts or actions.

If you have thoughts of harming or killing yourself at any time, tell your healthcare professional or go to a hospital right away. You will be closely monitored by a healthcare professional in this situation.

What is CONTRAVE used for?

CONTRAVE is used in adults together with a reduced-calorie diet and increased physical activity to manage weight in adults who are:

obese; or overweight and who have at least one weight-related problem, such as:

high blood pressure that is controlled by medicine, type 2 diabetes, or high levels of lipids in the blood (e.g., cholesterol or other types of fat).

It is not known if it is safe to take CONTRAVE with other weight loss products. Other products include prescription drugs, over the counter drugs, and natural health products. It is also not known if CONTRAVE changes your risk of heart or blood vessel problems (e.g., stroke) or of death due to heart or blood vessel problems.

CONTRAVE is not for use in patients younger than 18 years of age.

How does CONTRAVE work?

CONTRAVE contains two ingredients, naltrexone hydrochloride and bupropion hydrochloride. These medicines work on two separate areas of the brain to help control eating (appetite and cravings).

What are the ingredients in CONTRAVE?

Medicinal ingredients: Naltrexone Hydrochloride and Bupropion Hydrochloride.

Non-medicinal ingredients: Colloidal Silicon Dioxide, Crospovidone, Edetate Disodium, FD&C Blue No. 2 Indigo

Carmine Aluminum Lake, Hydroxypropyl Cellulose, Hypromellose, Lactose Anhydrous, Lactose Monohydrate, LCysteine Hydrochloride, Macrogol/Peg, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl Alcohol-Part Hydrolyzed, Talc, and Titanium Dioxide.

CONTRAVE comes in the following dosage forms:

Extended-release tablets: 8 mg of naltrexone hydrochloride and 90 mg of bupropion hydrochloride for each tablet. The tablets are blue, round, and have “NB-890” on one side.

Do not use CONTRAVE if:

you are allergic to naltrexone, bupropion, or any of the other ingredients in CONTRAVE. you have high blood pressure that cannot be controlled by medicine. you have severe liver problems.

you have end-stage kidney failure (kidney failure where the kidneys do not work enough to support the needs of your body). you have or had seizures.

you are taking thioridazine, an antipsychotic medicine that is typically used to treat schizophrenia and psychosis. An ingredient in CONTRAVE may cause the level of thioridazine in your blood to increase.

you are taking any other medicines which contain bupropion hydrochloride, such as WELLBUTRIN SR, WELLBUTRIN XL and ZYBAN. you have or had an eating disorder such as:

anorexia (eating very little), bulimia (eating too much and throwing up so you don’t gain weight).

you are dependent on opioid pain medicines or use medicines to help stop taking opioids (e.g., methadone or buprenorphine), or are in opioid withdrawal. you drink a lot of alcohol and abruptly stop drinking.

you take medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and you stop using them all of a sudden.

you are taking medicines called monoamine oxidase inhibitors (MAOIs).

Ask your healthcare professional if you are not sure if you take an MAOI.

Do not start CONTRAVE until you have stopped taking your MAOI for at least 14 days.

you are pregnant or planning to become pregnant. Tell your healthcare professional right away if you become pregnant while taking CONTRAVE.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CONTRAVE. Talk about any health conditions or problems you may have, including if you:

are at a higher risk of seizures. This includes if you:

have had a serious head injury.

have ever had any fits or seizures in the past, especially if you have ever had a seizure while taking

CONTRAVE, WELLBUTRIN SR, WELLBUTRIN XL, or ZYBAN;

have or have had a tumour or infection in your brain or spinal cord; have had a stroke (bleeding or blood clot in the brain); have blood vessel problems;

have low sodium or low sugar levels in your blood; have low oxygen levels in your body; have liver problems;

are addicted to cocaine or other drugs that stimulate your central nervous system; excessively take sedatives or have withdrawal symptoms from discontinuing sedatives; excessively drink alcohol;

have diabetes and take insulin or other medicines to control your blood sugar (e.g., sulfonylureas and meglitinides);

are taking medications that lower the seizure threshold (e.g., medicines used to treat depression and other mental health problems, theophylline, and systemic steroids).

have or had depression or other mental health problems.

have bipolar disorder or are at a higher risk for bipolar disorder (e.g., family history of bipolar disorder, suicidal thoughts or actions, or depression). have suicidal thoughts or actions or have attempted suicide in the past. have or had liver problems.

have high blood pressure that is controlled by medicine or have a higher risk of developing high blood pressure. have or had a heart attack.

have kidney problems. are over 65 years of age.

are lactose intolerant or have one of the following rare hereditary diseases:

Galactose intolerance

Lapp lactase deficiency

Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in CONTRAVE.

are dependent on alcohol or being treated for alcohol dependence. have significant weight loss.

have systemic lupus erythematosus (SLE), an autoimmune disease where your body’s immune system attacks your own tissues and organs.

have anatomically narrow angles (the space or angle between the cornea and iris is abnormally small).

have or have had a speech disorder where you stammer or stutter (dysphemia). Taking CONTRAVE may cause your speech disorder to come back or worsen.

Other warnings you should know about:

CONTRAVE can cause the following serious side effects:

Angle-closure glaucoma (eye pain caused by increased pressure in the eyes): One of the ingredients in CONTRAVE, bupropion, can cause an acute attack of glaucoma. Having your eyes checked before you take CONTRAVE could help identify if you are at risk of having angle-closure glaucoma. Get immediate medical help if you experience:

eye pain

changes in vision

swelling or redness in or around the eye

Blood pressure and heart rate increases: You may be more at risk if you already have high blood pressure.

Brugada syndrome (serious heart problem): Bupropion, one of the ingredients in CONTRAVE, may reveal a hidden heart problem you did not know you had, a problem called Brugada syndrome. Brugada syndrome can be serious and cause sudden death. Get immediate medical help if you experience fainting, dizziness, heart palpitations or abnormal heartbeat while taking CONTRAVE.

Before you start taking CONTRAVE, tell your healthcare professional if you:

have Brugada syndrome.

have unexplained fainting, or a family history of Brugada syndrome or unexplained sudden death before 45 years of age. This could mean you may have Brugada syndrome.

Hallucinations, delusions, paranoia (seeing, sensing or believing things that are not there).

Hypoglycemia (low blood sugar): You may be more at risk of developing hypoglycemia if you have type 2 diabetes, and you lose weight while taking CONTRAVE. This applies only if you take medicines to treat type 2 diabetes such as insulin or sulphonylureas. You may need a change in your medicine used to treat your diabetes.

Liver problems: This includes hepatitis (inflammation of the liver) and liver dysfunction.

Seizures (fits): The risk of having a seizure while taking CONTRAVE is related to the dose. It is important that you take CONTRAVE exactly as your healthcare professional tells you to. If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and get immediate medical help.

Your risk of seizures increases if you take CONTRAVE, especially:

if your dose of CONTRAVE increases; if you do not take CONTRAVE as directed; if you take CONTRAVE with high-fat meals; if you take certain medicines at the same time; if you are already at a higher than usual risk of seizures.

Serotonin toxicity (also known as serotonin syndrome): CONTRAVE can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. It is more likely to develop serotonin toxicity when you start taking CONTRAVE or when your dose is increased. It may also occur if you take CONTRAVE with certain antidepressants or migraine medications.

Serotonin toxicity symptoms include:

fever, sweating, shivering, diarrhea, nausea, vomiting;

muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination, flushing; fast heartbeat, changes in blood pressure;

confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, anxiety, and coma.

Severe allergic reaction:

CONTRAVE may cause an allergic reaction. Symptoms may include skin rash, hives, swelling of the face or throat, muscle pain, joint pain, difficulty breathing, severe skin reactions, chest pain or fever.

If you have an allergic reaction your symptoms may not go away even after you stop taking

CONTRAVE.

Severe skin reactions: Taking CONTRAVE may cause serious skin reactions. This included StevensJohnson Syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), and erythema multiforme. Stop taking CONTRAVE and get immediate medical help if you experience:

severe skin rash peeling of the skin

blisters around the mouth, eyes or genitals itching

chest pain swelling shortness of breath body aches fever

Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE): CONTRAVE has been associated with new or worsening symptoms in patients susceptible to SLE and CLE. These are autoimmune diseases where your body’s immune system attacks your own tissues and organs. Talk to your healthcare professional right away if you have blotchy rashes mainly on the face, fatigue, joint pain, swelling in the joints, muscle pain, rash, swelling, fever, nausea, or loss of appetite.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Alcohol:

CONTRAVE lowers your alcohol tolerance. This means you may feel the effects of alcohol when taking less alcohol than usual. Drinking alcohol while taking CONTRAVE may increase your risk of having seizures and allergic reactions. It is best not to drink alcohol at all while taking CONTRAVE to avoid side effects.

Pregnancy and Breastfeeding:

Do not take CONTRAVE if you are pregnant. Tell your healthcare professional right away if you become pregnant while taking CONTRAVE. They will discuss the risks of birth defects and complications after birth if you take CONTRAVE during pregnancy.

Talk to your healthcare professional if you are breastfeeding or thinking of breastfeeding. CONTRAVE passes into breastmilk. You should not breastfeed while you are taking CONTRAVE.

Opioid overdose:

If you take opioids while taking CONTRAVE, the ingredient naltrexone in CONTRAVE can increase your chance of having an opioid overdose. Examples of opioids or medicines that contain opioids include heroin, prescription pain medicines, and methadone.

You can accidentally overdose in two ways:

Naltrexone blocks the effects of opioids. Because of this, do not take large amounts of opioids to try to overcome the opioid-blocking effects of naltrexone. It can lead to serious injury, coma, or death.

After you take naltrexone, its blocking effect slowly decreases and goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with CONTRAVE can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:

after you have gone through detoxification when your next dose of CONTRAVE is due if you miss a dose of CONTRAVE after you stop CONTRAVE treatment

It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

Opioid withdrawal:

You should not use any type of opioid for at least 7 to 10 days before starting CONTRAVE. This includes street drugs, prescription pain medicines (including tramadol), cough, cold, diarrhea medicines that contain opioids, or opioid dependence treatments (e.g., buprenorphine or methadone). Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare professional if you are taking CONTRAVE before a medical procedure or surgery.

Testing and Check-Ups:

Your healthcare professional may perform certain tests (e.g., blood tests) to monitor:

your blood pressure and heart rate before and regularly during your treatment with CONTRAVE, especially if you have type 2 diabetes.

your blood sugar and red blood cell levels before and during your treatment with CONTRAVE, especially if you have type 2 diabetes.

any emotional and behavioural changes for the first few months after you start your treatment, and when your dose changes. This can include the feelings of depression, anxiety, agitation, irritability, behavioural changes, or suicidal thoughts and behaviour. if your kidneys are working properly. if your liver is working properly.

If you take a urine drug screening test, CONTRAVE may give a positive test result for amphetamines. Tell the laboratory technician that you are taking CONTRAVE. They can do a more specific drug screening test for you.

Driving and using machines:

CONTRAVE may impair your ability to do tasks requiring judgment, thinking or motor skills. You should not drive or use machines until you know how CONTRAVE affects you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious Drug Interactions

Serious drug interactions with CONTRAVE include:

medicines that contain bupropion hydrochloride (e.g., WELLBUTRIN XL, WELLBUTRIN SR, and ZYBAN);

monoamine oxidase inhibitors (MAOI) taken within the last 14 days, which are used to treat depression (e.g., phenelzine, selegiline, or rasagiline); medicines that contain thioridazine typically used to treat schizophrenia and psychosis.

Do not take CONTRAVE if you are taking any of these medicines. Ask your healthcare professional if you are unsure.

The following may interact with CONTRAVE:

alcohol. cimetidine, a medicine used to treat ulcers of the stomach and intestines. digoxin, a medicine used to treat various heart conditions. lithium, a medicine used to treat bipolar disorder. medicines used to help you to sleep (e.g., sedatives such as diazepam).

medicines used to lower your blood pressure (e.g., valsartan, clonidine, or beta blockers such as metoprolol).

medicines used to prevent epilepsy or seizures (e.g., carbamazepine, phenobarbital, phenytoin, or valproate).

medicines used to regulate your heart rhythm (e.g., propafenone or flecainide). medicines used to treat cancer (e.g., cyclophosphamide, ifosphamide, or tamoxifen).

medicines used to treat diabetes by helping to control sugar levels in the blood (e.g., metformin, insulin, sulphonylureas, glyburide, glibenclamide, nateglinide or repaglinide).

medicines used to treat depression and other mental health problems (e.g., citalopram, desipramine, venlafaxine, haloperidol, risperidone, selective serotonin reuptake inhibitors [SSRIs], imipramine, or paroxetine).

medicines used to treat hay fever, itch, swelling, and other allergic reactions (e.g., antihistamines or steroids). medicines used to treat heart disease or stroke (e.g., ticlopidine, digoxin, or clopidogrel). medicines used to treat HIV infection and AIDS (e.g., ritonavir, lopinavir, efavirenz, or orphenadrine). medicines used to treat infections (e.g., quinolones such as ciprofloxacin).

medicines used to treat Parkinson’s Disease (e.g., levodopa and amantadine). nifedipine, a medicine used to treat chest pain or high blood pressure.

opioids and medicines that contain opioids, used to treat:

cough and cold (e.g., mixtures containing dextromethorphan or codeine); opiate addiction (e.g., methadone); pain (e.g., morphine, codeine, or tramadol); diarrhea (e.g., loperamide).

theophylline, a medicine used to treat asthma and other lung diseases.

How to take CONTRAVE:

CONTRAVE must be taken with a reduced calorie-diet and increased physical activity.

Take CONTRAVE exactly as your healthcare professional tells you to.

Do not change your CONTRAVE dose without talking with your healthcare professional They will change your dose if needed. Your risk of seizures may increase if you take more CONTRAVE than your healthcare professional tells you to.

If you have not lost a certain amount of weight after 16 weeks of treatment, your healthcare professional may tell you to stop taking CONTRAVE.

CONTRAVE must be taken orally by mouth. Swallow CONTRAVE tablets whole. Do not cut, chew, or crush the tablets. Tell your healthcare professional if you cannot swallow CONTRAVE tablets whole.

Take each dose of CONTRAVE with food. Do not take CONTRAVE with high-fat meals as it may increase your risk of seizures.

Do not drink a lot of alcohol while taking CONTRAVE. Talk with your healthcare professional if you drink a lot of alcohol. If you suddenly stop drinking alcohol, you may increase your chance of having a seizure.

Usual dose:

Your healthcare professional will determine the right dose for you based on your health, your condition, and how you react to CONTRAVE. Your dose may be increased by your healthcare professional based on a weekly schedule. Never take more than you are prescribed per day.

The table below explains how the usual adult dose of CONTRAVE will be slowly increased over the first 4 weeks:

The maximum dose for CONTRAVE should not be exceed:

Do not take more than 2 tablets at the same time; and

Do not take more than 4 tablets in one day (e.g., 2 tablets in the morning and 2 tablets in the evening).

Overdose:

If you take too many CONTRAVE tablets, you may increase your risk of having serious and life-threatening effects, including:

seizures,

hallucinations (seeing or believing thing that are not there), loss of consciousness or coma, irregular heartbeat, fever,

muscle rigidity or muscle breakdown, low blood pressure, stupor,

difficulty breathing, heart problems,

serotonin toxicity (also known as serotonin syndrome), which is a serious condition that can be lifethreatening. See the Serious side effects and what to do about them table for more details.

If you think you, or a person you are caring for, have taken too much CONTRAVE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of CONTRAVE, do not take the missed dose. Instead, take the next dose at the usual scheduled time. Do not double the dose to make up for the missed dose.

What are possible side effects from using CONTRAVE?

These are not all the possible side effects you may feel when taking CONTRAVE. If you experience any side effects not listed here, tell your healthcare professional.

The common side effects of CONTRAVE include:

nausea; constipation; diarrhea; dizziness;

feeling off balance or like everything is spinning (vertigo); dry mouth; headache or migraine;

trouble sleeping; vomiting; abdominal pain; upset stomach; shaking (tremor);

foul, salty, rancid or metallic taste in the mouth; sleepiness, feeling tired, lack of energy; trouble paying attention; abnormal dreams;

flu;

excessive sweating more than usual; itching; rash; hair loss; ringing in the ear; blurred vision.

Serious side effects and what to do about them Talk to your healthcare professionalStop taking drug and get immediate medical Symptom / effectOnly if severeIn all caseshelp VERY COMMON
New or worsened anxiety	√
COMMON
New or worsened depression	√
UNCOMMON
Angle-closure glaucoma (eye pain caused by increased pressure in the eyes): eye pain, changes in vision, swelling or redness in or around the eye.		√
New or worsened emotional or behavioural problems: feeling very agitated or restless, sadness, feeling over-excited, acting aggressive, being angry or violent, acting on dangerous impulses or thoughts of harming others.		√
Blood pressure and heart rate increases: headaches, nosebleeds, dizziness, a flushed face, fatigue, or fast heart rate.	√

Symptom / effect	Serious side effects and what to do about them Talk to your healthcare professional Only if severe In all cases		Stop taking drug and get immediate medical help
Liver problems: pain in the stomach area lasting more than a few days, dark urine, yellowing of the whites of your eyes, tiredness.		√
RARE
Seizures (fit): uncontrollable shaking with or without loss of consciousness.			√
Suicidal thoughts and actions: thoughts about suicide or dying, attempts to commit suicide, or new or worse irritability.			√
Hypoglycemia (low blood sugar): sweating, nervousness, shaking, faintness, palpitations, and hunger.		√
Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE): red blotchy rash mainly on the face which may be accompanied by fatigue, pain or swelling in joints, muscle pain, fever, nausea, or loss of appetite.		√
VERY RARE
Severe allergic reaction: chest pain, fever, hives, itching in your eyes, painful sores in your mouth or around, rash, swelling of your lips or tongue, swollen lymph glands, or trouble breathing.			√

Symptom / effect	Serious side effects and what to do about them Talk to your healthcare professional Only if severe In all cases		Stop taking drug and get immediate medical help
Severe skin reactions (StevensJohnson Syndrome, acute generalised exanthematous pustulosis, and erythema multiforme): any combination of itchy skin rash, redness, blistering and peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands, joint pain, yellowing of the skin or eyes, dark urine.			√
Serotonin toxicity (also known as serotonin syndrome): a reaction which may cause feelings of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (>38°C), or rigid muscles.			√
UNKNOWN FREQUENCY
Manic episodes: feeling very high, irritable mood, talking fast, taking more risks, racing thoughts, and needing less sleep.			√
Panic attacks: sudden intense fear and discomfort.			√
Hallucinations, delusions or paranoia (sensing or believing thing that are not there).			√
If you had taken opioid medicines less than 7 – 10 days before taking CONTRAVE. Opioid withdrawal: nausea, vomiting, anxiety, insomnia, hot and cold flushes, perspiration, muscle cramps or diarrhea.			√
If you take opioid medicines while taking CONTRAVE. Opioid overdose: difficulty breathing, drowsiness with slowed breathing, slow, shallow breathing,			√
Symptom / effect feeling faint, dizziness, confusion, or having unusual symptoms.	Serious side effects and what to do about them Talk to your healthcare professional Only if severe	In all cases	Stop taking drug and get immediate medical help
Brugada syndrome (serious heart problem): dizziness, fainting, fast heartbeat, palpitations, abnormal heartbeat, seizures (fits), abnormal breathing while sleeping.			√

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or

Calling toll-free at 1-866-234-2345.

Note: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store CONTRAVE at room temperature between 15°C to 25°C.

Keep container tightly closed.

If your healthcare professional tells you to stop taking CONTRAVE, return any leftover medicine to your pharmacist.

Keep out of reach and sight of children.

If you want more information about CONTRAVE:

Talk to your healthcare professional.

Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/healthcanada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.bauschhealth.ca, or by calling 1-800-361-4261.

This leaflet was prepared by:

Bausch Health, Canada Inc.

2150 St-Elzear Blvd., West

Laval, QC, H7L 4A8 www.bauschhealth.ca

This Information for the Patient handout was developed by the pharmaceutical manufacturer in accordance with the requirements of Health Canada. CPhA assumes no responsibility for or liability in connection with the use of this handout. Once printed there is no guarantee the information is up-todate. [Printed on: 09-18-2024 11:54 AM]

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

PATIENT MEDICATION INFORMATION

^PrWegovy^®

semaglutide injection

Read this carefully before you start taking Wegovy^® and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about Wegovy^®.

Serious Warnings and Precautions

Possible Risk of thyroid tumours, including cancer

As part of drug testing, semaglutide, the active ingredient in Wegovy^® was given to rats and mice in long term studies. In these studies, semaglutide caused both rats and mice to develop medullary thyroid tumours, some of which were cancer. It is not known if semaglutide will cause thyroid tumours or a rare type of thyroid cancer called medullary thyroid cancer in people. Do not use Wegovy^® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

While taking Wegovy^®, tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing or shortness of breath. These may be symptoms of thyroid cancer. You should discuss any safety concerns you have about the use of Wegovy^® with your doctor.

What is Wegovy^® used for?

Wegovy^® is used for chronic weight management in addition to reduced calorie diet and increased physical activity in adults, who have:

a BMI of 30 kg/m² or greater (with obesity), or
a BMI of 27 kg/m² and less than 30 kg/m² (overweight) and weight-related health problems.

*BMI (Body Mass Index) is a measure of your weight in relation to your height. See your doctor to have your BMI measured.

Wegovy^® is used for chronic weight management in addition to a reduced calorie diet and increased physical activity in adolescents aged 12 to less than 18 years, who have obesity, as diagnosed by a doctor, and who have not succeeded in weight loss with diet and exercise alone.

How does Wegovy^® work?

Wegovy^® is similar to a natural hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal. Wegovy^® works by causing you to feel fuller and less hungry Wegovy^® should be used along with a reduced calorie diet and increased physical activity.

What are the ingredients in Wegovy^®? Medicinal ingredients: semaglutide

Wegovy™ (semaglutide injection) Product Monograph

Single-Use Pen

Non-medicinal ingredients: Disodium phosphate dihydrate; Hydrochloric acid; Sodium Chloride; Sodium hydroxide; Water for injection

Multi-Use pen

Non-medicinal ingredients: Disodium phosphate dihydrate; Propylene glycol; Phenol; Hydrochloric acid; Sodium hydroxide; Water for injection

Wegovy^® comes in the following dosage forms:

Wegovy^® is supplied as a clear and colourless solution for injection in a pre-filled pen.

Wegovy^® is available in a carton of 4 single-use, disposable, pre-filled pens delivering doses of either 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, or 2.4 mg. The 0.25 mg, 0.5 mg and 1 mg pens contain 0.5 mL solution. The 1.7 mg and 2.4 mg pens contain 0.75 mL of solution.

Wegovy^® is available in a carton of 1 multi-use, disposable, pre-filled pen delivering doses of either 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, or 2.4 mg. The 0.25 mg and 0.5 mg pens contain 1.5 mL solution. The 1 mg,1.7 mg and 2.4 mg pens contain 3 mL of solution.

Your single-use pen is only to be used once. It comes with:

One pre-set dose.
A needle cover that hides the built-in needle before, during and after use.
Automatic dosing that starts when the needle cover is pressed against your skin as described by your healthcare professional.

Your multi-use pen can be used multiple times. It comes with:

Four doses of either 0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg.
4 disposable needles

Do not use Wegovy^® if:

You are allergic to semaglutide or any of the other ingredients of this medicine.
You or a member of your family has ever had medullary thyroid cancer (MTC).
You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
You are pregnant or breastfeeding.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Wegovy^®. Talk about any health conditions or problems you may have, including if you:

or a member of your family has or has had medullary thyroid carcinoma (MTC), or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Have type 1 diabetes.
Have ever had diabetic ketoacidosis (increased ketones in the blood or urine).
Have ever had an allergic reaction to OZEMPIC^®or RYBELSUS^®.
Have a high heart rate (fast pulse).
Have ever had an inflamed pancreas (pancreatitis).
Are breastfeeding or plan to breastfeed.
Are pregnant or plan to become pregnant.
Have end stage renal disease.
Have gastrointestinal (digestive) problems, including severe vomiting, diarrhea and/or dehydration.
Have hepatic (liver) disease.
Have diabetic eye disease (diabetic retinopathy).
Have heart failure.
Have ever had gallbladder disease.
Have ever attempted suicide, or had suicidal thoughts or depression.

Other warnings you should know about:

Children and adolescents

Wegovy^® is not recommended in children and adolescents under 12 years of age or less than 60 kg (132 lbs) as the safety and efficacy in this age and weight group have not yet been studied.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. Wegovy^® should not be used during pregnancy and for at least two months before a planned pregnancy because it is not known if it may affect your unborn child.

If you could become pregnant while using Wegovy^®, it is recommended to use contraception.

Do not use this medicine if you are breast-feeding. This is because it is not known if Wegovy^® passes into breast milk.

Driving and using machines

If you use this medicine in combination with certain diabetes medications (e.g. sulfonylurea or insulin), low blood sugar may occur which may reduce your ability to concentrate or make you feel dizzy. Avoid driving or using machines if you feel dizzy or unable to concentrate. Talk to your doctor for further information.

Severe and on-going stomach pain which could be due to inflammation of the pancreas If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be a sign of acute pancreatitis (inflamed pancreas).

Effects on the digestive system and dehydration

During treatment with Wegovy^®, you may experience feeling sick (nausea) or being sick (vomiting), and diarrhea. These side effects can cause dehydration (loss of fluids). It is therefore important to drink plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

Diabetic eye disease (retinopathy)

This medication may cause a temporary worsening of diabetic eye disease. If you have diabetic eye disease and experience eye or vision problems while taking this medication, talk to your doctor.

Low blood sugar (hypoglycemia)

If you are taking certain diabetes medication (e.g. sulfonuylurea or insulin) when you start taking Wegovy^®, this could result in low blood sugar levels. Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of your diabetes medication needs to be changed.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

People with Diabetes

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following:

sulfonylurea
insulin

Do not use Wegovy^® as a substitute for insulin.

The following may interact with Wegovy^®:

The following list includes some, but not all, of the drugs that may increase your heart rate. You should check with your doctor or pharmacist before taking any other medication with Wegovy^®:

Drugs to treat hypertension.
Drugs to treat heart failure.
Drugs to treat HIV infection.
Drugs to treat attention deficit-hyperactivity disorder.
Drugs to suppress appetite/cause weight loss.
Drugs to treat asthma.

How to take Wegovy^®

Wegovy^® is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle. The best places to give the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm.

Before you use the pen for the first time, your healthcare professional will show you how to use it.

Detailed instructions for use are on the other side of this leaflet.

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

You should use Wegovy^® once a week on the same day each week if possible. You can give yourself the injection at any time of the day – regardless of meals. To help you remember to inject Wegovy^® once a week only, it is recommended to note the chosen day of the week (e.g. Wednesday) on the carton.

If necessary, you can change the day of your weekly injection of Wegovy^® as long as it has been at least 3 days since your last injection of Wegovy^®.

Your doctor should start you on a reduced calorie meal plan and physical activity program when you start taking Wegovy^®. Stay on this program while you are taking Wegovy^®.

Usual dose:

Adults

The recommended dose is 2.4 mg once weekly.

Your treatment will start at a low dose which will be gradually increased over 16 weeks of treatment.

When you first start taking Wegovy^®, the starting dose is 0.25 mg once weekly
Your doctor will instruct you to gradually increase your dose every 4 weeks until you reach the recommended dose of 2.4 mg once weekly.

You will be told to follow the table below.

Dose escalation	Weekly Dose
Week 1 – 4	0.25 mg
Week 5 – 8	0.5 mg
Week 9 – 12	1 mg
Week 13 – 16	1.7 mg
Maintenance Dose	2.4 mg

Once you reach the recommended dose 2.4 mg, keep using this dose. Do not increase your dose further.

Your doctor will assess your treatment on a regular basis and may tell you to change your dose if necessary.

Do not stop using this medicine without talking to your doctor.

Adolescents

For adolescents aged 12 to less than 18 years, the same dose escalation schedule as for adults should be applied (see above). Adolescents should aim at reaching the 2.4 mg maintenance dose, but can stay at a lower dose if the 2.4 mg dose cannot be reached or is not tolerated.

Overdose:

If you use more Wegovy^® than you should, talk to your doctor straight away. You may get side effects such as feeling sick (nausea) or being sick (vomiting), or diarrhea, or hypoglycemia (dizziness, confusion, passing out).

If you think you have taken too much Wegovy^®, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you forgot to inject a dose and:

It is 5 days or less since you should have used Wegovy^®, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
It is more than 5 days since you should have used Wegovy^®, skip the missed dose. Then inject your next dose as usual on your scheduled day.

Do not take a double dose to make up for a missed dose.

What are possible side effects from using Wegovy^®?

These are not all the possible side effects you may feel when taking Wegovy^®. If you experience any side effects not listed here, contact your healthcare professional.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 people

feeling or being sick (nausea or vomiting)
diarrhea
constipation
stomach pain
feeling weak or tired
headache

– these usually goes away over time

Common: may affect up to 1 in 10 people

feeling dizzy
upset stomach or indigestion
burping
gas (flatulence)
bloating of the stomach
inflamed stomach (‘gastritis’) – the signs include stomach-ache, feeling sick (nausea) or being sick (vomiting)
reflux or heartburn – also called ‘gastro-esophageal reflux disease’
hair loss
injection site reactions
low blood sugar (hypoglycaemia) in patients with diabetes
low blood pressure
increase of pancreatic enzymes (such as lipase) shown in blood tests
hemorrhoids
change in the way food or drink tastes

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.

Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.

Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.

Uncommon: may affect up to 1 in 100 people

fast heartbeat
increase of pancreatic enzymes (such as amylase) shown in blood tests
feeling faint or fainting/passing out
low blood sugar (hypoglycemia) in patients without diabetes

Unknown:

ileus (a severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc)
bowel obstruction
a delay in the emptying of the stomach

Serious side effects and what to do about them
Symptom / effect	Talk to your healthcare professional		Stop taking drug and get immediate medical help
Symptom / effect	Only if severe	In all cases	Stop taking drug and get immediate medical help
COMMON Patients with Type 2 Diabetes – Diabetic retinopathy complications – complications of diabetic eye disease/diabetic eye problems		√
Gallstones Symptoms: sudden pain in the upper stomach or back, often on the right, nausea, vomiting, indigestion, or cramping		√	√
UNCOMMON Pancreatitis (severe and ongoing pain in the stomach area which could be a sign of inflamed pancreas)		√	√
Patients with Type 2 Diabetes – Severe hypoglycemia (low blood sugar) symptoms: feeling confused, fits and passing out		√
Appendicitis Symptoms: sudden pain in the middle or lower right side of the abdomen, chills, fever, nausea, vomiting		√	√
Acute kidney injury Symptoms: swelling in the legs, ankles and feet, feeling tired, confusion, shortness of breath, not enough urine		√	√
RARE Severe allergic reaction (anaphylactic reaction, angioedema) symptoms: breathing problems, swelling of face, lips, tongue and/or throat with difficulty swallowing, and a fast heartbeat		√	√

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting

(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffectcanada.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Keep out of reach and sight of children.

Do not use this medicine after the expiry date which is stated on the pen label and carton after ʻEXP’. The expiry date refers to the last day of that month.

Keep away from the cooling element of the refrigerator. Do not freeze Wegovy^® and do not use Wegovy^® if it has been frozen. Protect from excessive heat and light.

Wegovy^® pen is for use by one person only.

Wegovy^® should not be used if it does not appear clear and colourless.

Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

Single-Use Pen

Store the Wegovy^® single-use pen in the refrigerator at 2°C to 8°C. If needed, each single-use pen, prior to cap removal, can be kept at a temperature below 30°C for a total of 28 days.

If your pen has been exposed to light or temperatures above 30°C, has been out of the refrigerator for more than 28 days, or has been frozen, dispose of it.

Storage of Wegovy^® single-use pen in the original carton is recommended until time of administration in order to protect from light.

Safely discard the Wegovy^® single-use pen into a sharps disposal container after use. Do not dispose of the pen in your household trash.

Multi-Use Pen

When you are not using the pen, keep the pen cap on in order to protect from light.

Before Opening:

Store in a refrigerator (2°C – 8°C).

During Use:

You can keep the pen for 8 weeks when stored at a temperature below 30°C or in a refrigerator (2°C – 8°C).

If your pen has been exposed to temperatures above 30°C, has been out of the refrigerator for more than 8 weeks, or has been frozen, dispose of it.

Always remove the injection needle after each injection and store the pen without a needle attached. This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.

If you want more information about Wegovy^®:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website(http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website www.novonordisk.ca, or by calling 1-800-465-4334.

This leaflet was prepared by Novo Nordisk Canada Inc.

Last Revised 2024

Wegovy^®, NovoFine^®, NovoFine^® Plus and Novo Nordisk are trademarks of Novo Nordisk A/S and used under license by Novo Nordisk Canada Inc.

Novo Nordisk Canada Inc.

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PATIENT MEDICATION INFORMATION :

HUMATROPE® M

somatropin

Biosynthetic Human Growth Hormone of Recombinant DNA Origin—Growth Stimulant Lilly

Date of Revision: September 16, 2021

IMPORTANT: PLEASE READ: This leaflet is for patients and caregivers. It is Part III of a three-part “Product Monograph” published when HUMATROPE was approved for sale in Canada. This leaflet is a summary and will not tell you everything about HUMATROPE. Contact your doctor or pharmacist if you have any questions about the drug.

Please read this information carefully before you start to take your medicine, even if you have just refilled your prescription. Some of the information may have changed. Keep this pamphlet since you may need to refer to it after starting treatment with HUMATROPE.

About This Medication: What the medication is used for:

HUMATROPE is used to treat children and teenagers who are short or growing too slowly due to a medical condition such as growth hormone deficiency, Turner syndrome, idiopathic short stature, SHOX (short stature homeobox-containing gene) deficiency, or being born small for gestational age.

HUMATROPE is also used in some adults who had growth hormone deficiency when they were children and still have growth hormone deficiency after they finish growing, or who do not make enough growth hormone as adults for some other reason.

What it does:

HUMATROPE is used to increase growth hormone levels. It stimulates bone growth in children unless the ends of the bones have hardened (closed epiphyses). In both adults and children with growth hormone deficiency, it also increases the growth of muscle and reduces body fat.

When it should not be used:

Treatment should not be started:

in children to promote growth when the ends of the long bones have hardened (closed epiphyses). Treatment should be stopped when adult height is reached. Réévaluation to find out whether the patient still has growth hormone deficiency will determine if continued treatment with HUMATROPE at a lower dose would be beneficial.
in patients with any evidence of an active cancer (either newly diagnosed or recurrent).
while patients have a serious illness following heart or abdominal surgery, or in patients who have just had a serious accident, or those with acute respiratoryfailure (low level of oxygen in the blood or high level of carbon dioxide in the blood).
in patients with Prader-Willi syndrome who are very obese or have severe breathing problems. There have been reports of deaths in children with Prader-Willi syndrome who were treated with growth hormone and had one or more of the following risk factors: severe obesity, breathing problems, colds or lung infections.

Treatment should not be started

in patients known to be allergic to somatropin (the active substance in HUMATROPE), or to any of the ingredients in the powder or the diluent (listed below).
in patients who have undergone kidney transplant, until one year post-transplant.
in patients with diabetic retinopathy, a complication of diabetes that results from damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina).

What the medicinal ingredient is:

Somatropin (recombinant human growth hormone).

What the important nonmedicinal ingredients are:

The HUMATROPE powder contains freeze-dried somatropin, dibasic sodium phosphate, glycine, and mannitol. The diluent (solution for dissolving somatropin) contains metacresol and glycerin.

Phosphoric acid and/or sodium hydroxide may have been added at the time of manufacture to adjust the acidity of the liquid. What dosage forms it comes in:

HUMATROPE is supplied as follows:

Cartridges: 6 mg, 12 mg, or 24 mg cartridges, each with 3.15 mL of diluent.

HUMATROPE cartridges require the use of a HumatroPen to inject the drug. HumatroPens are supplied separately.

Warnings and Precautions:

Serious Warnings and Precautions

A doctor trained in hormone and growth disorders must examine the patient to decide if it is safe to use HUMATROPE. After the HUMATROPE powder has been dissolved it must be water-clear and free of particles.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms seem the same as yours.

When medicine is injected into the same place over a long time, it can cause loss of fat tissue under the skin. It is therefore important to keep changing the injection site, and the doctor or nurse can tell you how.

Before using HUMATROPE, the patient or caregiver should tell the doctor:

if the patient has an active brain tumour or any other tumour (either benign or cancerous). However, the doctor may prescribe HUMATROPE if the patient has had a brain tumour and needs no more anti-tumour treatment for it. The patient should be re-examined frequently to make sure that the tumour has not come back or started to grow.
if the patient is a survivor of childhood cancer.
if the patient is very ill after a serious operation, or after being treated for multiple injuries from an accident, or if the patient has sudden serious breathing problems.
if the patient has diabetes (because more or less insulin may be needed when taking HUMATROPE).
if a member of the patient’s family has diabetes.
if the patient is taking a steroid medication (glucocorticoid) such as cortisone or prednisone. This is because the combination may reduce the success of the HUMATROPE treatment or because more of the steroid medication may be needed when the patient is also taking HUMATROPE.
if the patient is taking a medication known to be metabolized by certain liver enzymes (e.g., cyclosporine, some anticonvulsants, and hormones such as estrogen and birth control pills). This is because the treatment with HUMATROPE may reduce the effectiveness of these drugs.
if the patient, especially a child, develops abdominal pain.
if the patient is or plans to become pregnant, or is breast-feeding.
if the patient has hypothyroidism (low levels of thyroid hormone), because HUMATROPE may reduce the levels of thyroid hormone. The patient may require a change in dosage of his or her thyroid hormone medication.
if the patient suffers from a bad headache or frequent headaches, or from problems with eyesight, vomiting or feeling sick. Very rarely, swelling of the brain may develop, and the doctor may want to examine the patient to look for signs of brain swelling. If this occurs it may be necessary to stop HUMATROPE treatment.
if the patient develops a limp, or has hip or knee pain while being treated with HUMATROPE;
if the patient has known hypersensitivity to somatropin or to any ingredient in the formulation.

If the patient has Turner syndrome and develops an ear infection or headaches her doctor should be told about these problems.

If the patient is growth hormone-deficient and also has Prader-Willi syndrome (a genetic disorder), the doctor should examine the patient for breathing problems and airway infections before starting HUMATROPE treatment, especially if the patient is overweight, has previously experienced severe breathing problems (especially during sleep), or suffered infection of the lungs or airways. If during treatment the patient has signs of breathing problems (snoring), treatment should be interrupted and the cause assessed by the doctor.

Treatment with HUMATROPE can change blood sugar levels.

The doctor should check the patient’s blood sugar regularly while taking HUMATROPE, especially if there are risk factors for diabetes. Patients who have diabetes or impaired glucose tolerance should have their blood sugar closely monitored during HUMATROPE therapy.

Leukemia has been reported in a small number of pediatric patients who have been treated with growth hormone, including growth hormone of pituitary origin, and man-made growth hormone products such as somatrem and somatropin. The relationship, if any, between leukemia and growth hormone is uncertain.

Progression of pre-existing scoliosis (curvature of the spine) can occur in children who have rapid growth. HUMATROPE has not been shown to increase the occurrence of scoliosis.

If the patient has hypopituitarism and is receiving standard hormone replacement therapy, the doctor should monitor the hormone replacement therapy closely during HUMATROPE treatment.

If the patient has a growth disorder associated with being born small for gestational age, the blood sugar and insulin levels should be checked before starting treatment and regularly during treatment.

Patients over 65 years of age may be more sensitive to HUMATROPE and may require lower dose of HUMATROPE.

Interactions with This Medication:

Tell the doctor If the patient Is taking any of the following drugs:

Steroid medications such as glucocorticoids (e.g., cortisone or prednisone)
Medications known to be metabolized by certain liver enzymes (e.g., cyclosporine, some anticonvulsants, and hormones such as estrogen and birth control pills)
Insulin and antl-hyperglycemlc agents

Because HUMATROPE may affect how some hormones, such as Cortisol and cortisone, are processed In the body, people may discover that they have an underactive adrenal gland after starting HUMATROPE therapy. In these cases, glucocorticoid replacement therapy would need to be started. If already on glucocorticoid therapy, dosage may need to be adjusted.

Proper Use of This Medication:

Be sure to change the Injection site frequently to help prevent llpoatrophy (loss of fat tissue under the skin). In general, HUMATROPE should be Injected In the evening or before bedtime.

Usual dose:

The doctor will Instruct you on what Is the best dose of HUMATROPE for you (or your child) based on Individual needs. Use HUMATROPE exactly as the doctor tells you to.

Reconstitution Instructions:

Please refer to the enclosed Reconstitution Instructions for HUMATROPE Cartridges:. Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Long-term overdosage or using HUMATROPE after the growth plates in the long bones have closed (hardened) may result in joint pain and continued growth of fingers, toes, nose, ears or jaw. If you think this is happening, tell the doctor.

Overdose may change blood sugar levels, and patients may experience symptoms of hypoglycemia (low blood sugar), such as feeling shaky, dizzy and unwell or hyperglycemia (high blood sugar), such as increased urination or thirst.

Missed dose:

Contact your physician or pharmacist if you have missed a dose.

Side Effects and What to Do About Them:

Some people may be allergic to the diluent (liquid used to mix with the HUMATROPE powder). If there is any pain or redness at the injection site, or if there is any swelling, tell your doctor.

Rarely, more severe allergic reactions may occur. Seek immediate medical help if you (or your child) experience any sudden trouble breathing, with swelling of the hands, feet or face.

Children treated with HUMATROPE may have an increased risk of developing an inflammation of the pancreas called pancreatitis. If your child develops severe abdominal pain, contact your doctor.

It is also important to have blood glucose checked if the patient has diabetes or a family history of diabetes.

HUMATROPE may affect the way the body handles sugars from food and drink. The doctor may need to check the amount of sugar in the urine or blood.

HUMATROPE can affect the amount of thyroid hormone in the blood, so patients must have thyroid function tests from time to time. If the thyroid is not working properly, HUMATROPE may not work as well as it should.

Any child who begins to limp must be examined by a doctor.

HUMATROPE may cause intracranial hypertension (increased pressure within the skull). Call the doctor if the patient has: a headache that doesn’t go away or is severe, or has headaches that become more frequent; problems with vision; nausea (feeling sick in the stomach) or vomiting.

Other possible side effects include headaches, muscle or joint pains (in hips or knees), swelling associated with tingling sensations in the hands, feeling weak, rarely high blood pressure, shortness of breath, and sleep apnea (pauses in breathing during sleep). If the headaches are bad or frequent, and accompanied by sickness or vision problems, tell the doctor immediately.

For patients with Turner syndrome, HUMATROPE therapy may increase the already high frequency of ear infections. Your child should see her doctor if you think she has an ear infection.

This is not a complete list of side effects. If any of the side effects gets serious, or if you notice any unexpected side effects while taking HUMATROPE, contact your doctor or healthcare professional.

How to Store It:

Before it has been reconstituted (mixed):

Store HUMATROPE cartridges and diluent in the refrigerator at 2-8°C (36-46°F).

After it has been reconstituted (mixed):

When the cartridge is prepared with the supplied diluent, it may be stored in the refrigerator at 2-8°C (36-46°F) and MUST be used within 28 DAYS. Do NOT freeze.

Keep out of reach of children.

Reporting Suspected Side Effects

Reporting Suspected Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

Note: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More Information:

For more information, please contact your healthcare professional or pharmacist first, or Eli Lilly Canada Inc. at: 1-888-545-5972, or visit the website at: www.lilly.ca

The information in this document is current as of the last revision date shown above. For the most current information please visit our website or contact us directly.

This leaflet was prepared by Eli Lilly Canada Inc.

PrGenotropin GoQuick

Human Growth Hormone

This leaflet is part III of a three-part “Product Monograph” published when Genotropin was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about Genotropin. Contact your doctor if you have any questions about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

In children, Genotropin is used to treat the following growth problems:

If you are not growing properly and you do not have enough of your own growth hormone.

If you have Turner syndrome. Turner syndrome is a chromosomal error in girls that can affect growth – your doctor will have told you if you have this.

If you were small or too light at birth. Growth

hormone may help you grow taller if you have not been able to catch up or maintain normal growth by two years of age or later.

If you have idiopathic (unknown cause) short stature.

In adults, Genotropin is used to treat persons with pronounced growth hormone deficiency. This can start during adult life, or it can continue from childhood.

If you have been treated with Genotropin for growth hormone deficiency during childhood, your growth hormone status will be retested after completion of growth. If severe growth hormone deficiency is confirmed, your doctor will propose continuation of Genotropin treatment.

What it does:

Genotropin is a recombinant human growth hormone (also called somatropin). It has the same structure as natural human growth hormone which is needed for bones and muscles to grow. It also helps your fat and muscle tissues to develop in the right amounts. Recombinant means it is made using bacteria instead of being taken out of human or animal tissue.

When it should not be used:

You are allergic (hypersensitive) to somatropin or any of the other ingredients of Genotropin.

You have an active tumour. Tumours must be inactive and you must have finished your anti-tumour treatment before you start using Genotropin.

You are seriously ill (for example, complications following open heart surgery, abdominal surgery, acute respiratory failure, accidental trauma or similar conditions). If you are about to have, or have had, a

major operation, or go into hospital for any reason, tell your doctor and remind the other doctors you are seeing that you use growth hormone.

Genotropin has been prescribed to stimulate growth but you have already stopped growing (the growth plates on your long bones are closed).

In patients with Prader-Willi syndrome who are very obese or have severe breathing problems. There have been reports of deaths in children with Prader-Willi syndrome who were treated with growth hormone and had one or more of the following risk factors: severe obesity, breathing problems, colds or lung infections.

In patients with diabetic retinopathy, a complication of diabetes that results from damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina).

What the medicinal ingredient is:

Genotropin is a recombinant human growth hormone (also called somatropin).

What the important nonmedicinal ingredients are: Each cartridge in the pre-filled pen contains 5mg, 5.3 mg or 12 mg of somatropin. The Genotropin powder contains glycine, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous and mannitol.

The diluent (solution for dissolving somatropin) contains water for injection, mannitol and metacresol.

What dosage forms it comes in:

Genotropin is presented in a cartridge with two sections that is contained in a multi-dose, disposable pre-filled pen called GoQuick. One section contains the powder for solution for injection and the other contains the liquid for solution for injection. The powder is white and the liquid is clear.

When mixed together, the powder and the liquid make 1 ml of solution for injection.

Genotropin is available in pack sizes of 1 GoQuick pre-filled pen and 5 GoQuick pre-filled pens. Not all strengths and pack sizes are marketed in Canada.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Before taking GENOTROPIN, talk to your doctor or pharmacist if:

The child has Prader-Willi Syndrome and breathing problems, sleep apnea (not breathing while sleeping), snoring or a respiratory infection.

A doctor trained in hormone and growth disorders must examine the patient to decide if it is safe to use GENOTROPIN.

After the GENOTROPIN powder has been dissolved it must be water-clear and free of particles.

GENOTROPIN* (somatropin for injection)

IMPORTANT: PLEASE READ

BEFORE using Genotropin, the patient or caregiver should tell the doctor:

If the patient is at risk of developing diabetes, the doctor will need to monitor their blood sugar level during treatment with Genotropin.

If the patient has diabetes, they should closely monitor their blood sugar level during treatment with Genotropin and discuss the results with their doctor to determine whether they need to change the dose of their medicines to treat diabetes.

If the patient is receiving treatment with thyroid hormones it may be necessary to adjust their thyroid hormone dose. If the patient is taking growth hormone to stimulate growth and walk with a limp or if they start to limp during their growth hormone treatment due to pain in their hip, they should inform their doctor.

If the patient develops a strong headache, visual disturbances or vomiting they should inform their doctor about it.

If their doctor confirms that the patient has developed inflammation of the muscles near the injection site because of the preservative metacresol, they should use a Genotropin product without metacresol.

If the patient is receiving Genotropin for growth hormone deficiency following a previous tumour, they should be examined regularly for recurrence of the tumour. If the patient is a survivor of childhood cancer.

If the patient, especially a child, develops severe abdominal pain (inflammation of the pancreas).

If the patient is, or plans to become pregnant or is breast feeding.

If the patient develop a limp while being treated with GENOTROPIN.

If the patient has Turner syndrome and develops an ear infection or headaches her doctor should be told about these problems.

If the patient has hypopituitarism and is receiving standard hormone replacement therapy, the doctor should monitor the hormone replacement therapy closely during GENOTROPIN treatment.

After starting Genotropin treatment some patients may need to start thyroid hormone replacement.

Progression of pre-existing scoliosis (curvature of the spine) can occur in children who have rapid growth.

The patient should not use Genotropin if they are pregnant or are trying to become pregnant.

INTERACTIONS WITH THIS MEDICATION

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

You should tell your doctor if you are using:

medicines to treat diabetes,

thyroid hormones,

synthetic adrenal hormones (corticosteroids),

sex hormones (for example estrogens),

cyclosporine (a medicine that weakens the immune system after transplantation),

medicines to control epilepsy (anticonvulsants).

Your doctor may need to adjust the dose of these medicines or the dose of Genotropin.

PROPER USE OF THIS MEDICATION

Recommended dosage

The dose depends on your size, the condition for which you are being treated and how well growth hormone works for you. Everyone is different. Your doctor will advise you about your individualized dose of Genotropin in milligrams (mg) from either your body weight in kilograms (kg), as well as your treatment schedule. Do not change the dosage and treatment schedule without consulting your doctor.

Children with growth hormone deficiency:

0.16-0.24 mg/kg body weight per week. Higher doses can be used. When growth hormone deficiency continues into adolescence, Genotropin should be continued until completion of physical development.

Children with Turner syndrome:

0.33 mg/kg body weight per week.

Children with idiopathic short stature:

UP TO 0.47 mg/kg body weight per week

Children born smaller or lighter than expected and with growth disturbance:

UP TO 0.48 mg/kg body weight per week. Your doctor will determine the most appropriate dose and length of treatment. Treatment should be discontinued if: i) after the first year if you are not responding or ii) if you have reached your final height and stopped growing.

Adults with growth hormone deficiency:

You should start with 0.15-0.3 mg per day.

This dosage should be gradually increased or decreased according to blood test results as well as clinical response and side effects.

Follow the instructions given to you by your doctor.

Injecting Genotropin

Genotropin is intended for subcutaneous use. This means that it is injected through a short injection needle into the fatty tissue just under your skin. Your doctor should have already shown you how to use Genotropin. Always inject Genotropin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

GENOTROPIN* (somatropin for injection) Product Monograph Page 59 of 90

IMPORTANT: PLEASE READ

Read carefully the GoQuick Instructions for Use included in this package leaflet. You must use the pen as described in the Instructions for Use.

The needle must be screwed on to the GoQuick pen before mixing. Use a new needle before each injection. Needles must not be re-used.

Preparing the injection:

You can take your Genotropin out of the refrigerator half an hour before your injection. This lets it warm up slightly and can make your injections more comfortable.

The two-chamber cartridge that contains both the growth hormone and the dissolving liquid is contained in the GoQuick pen. The growth hormone and the dissolving liquid are mixed together by twisting the cartridge holder (see the detailed steps in Instructions for Use). Dissolve the powder by gently tipping the GoQuick pen back and forth 5-10 times until the powder is dissolved.

When you are mixing your Genotropin, DO NOT SHAKE the pen. Mix it gently. Shaking the solution could make your growth hormone foam and damage the active substance. Check the solution and do not inject if the solution is cloudy or has particles in it.

Injecting Genotropin:

Remember to wash your hands and clean your skin first.

Inject your growth hormone at about the same time every day. Bedtime is a good time because it is easy to remember. It is also natural to have a higher level of growth hormone at night.

Most people do their injections into their thigh or their bottom. Do your injection in the place you have been shown by your doctor. Fatty tissue of the skin can shrink at the site of injection. To avoid this, use a slightly different place for your injection each time. This gives your skin and the area under your skin time to recover from one injection before it gets another one in the same place.

Remember to put your Genotropin back in the refrigerator straight after your injection.

If you use more Genotropin than you should

If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or “not yourself”, and you might faint.

If you forget to use Genotropin

Do not use a double dose to make up for a forgotten dose. It is best to use your growth hormone regularly. If you forget to use a dose, have your next injection at the usual time the next day. Keep a note of any missed injections and tell your doctor at your next check-up.

If you stop using Genotropin

Ask for advice from your doctor before you stop using Genotropin.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Genotropin can cause side effects, although not everybody gets them.

Common side effects (likely to occur in fewer than 1 in 10 patients) include:

Formation of antibodies to the injected growth hormone but these do not seem to stop the growth hormone from working.

In children:

Temporary reddening, itchiness or pain at the

injection site.

In adults:

Numbness / tingling,

Stiffness in the arms and legs, joint pain, muscle

pain,

Water retention (which shows as puffy fingers or swollen ankles). These symptoms may be seen for a short time at the start of treatment, but they

disappear spontaneously or when the dosage is

lowered.

These common side effects in adults may start within the first months of treatment and may either stop

spontaneously or if your dose is reduced.

Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:

In children:

Numbness / tingling,

Stiffness in the arms and legs, joint pain, muscle

pain,

Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of

treatment).

In adults:

Pain or burning sensation in the hands or

underarms (known as Carpal Tunnel Syndrome).

Rare side effects (likely to occur in fewer than 1 in 1,000 patients) include:

Type 2 diabetes mellitus,

Intracranial hypertension (increased pressure within the skull due to swelling of the brain) which causes symptoms such as a strong headache that doesn’t go

away, vision problems, nausea or vomiting. Call your doctor if the patient has any of these symptoms.

GENOTROPIN* (somatropin for injection)

IMPORTANT: PLEASE READ

Very rare side effects (likely to occur in fewer than 1 in 10,000 patients) include:

Leukemia.

The skin around the injection area can get uneven or lumpy, but this should not happen if you inject in a different place each time.

A very rare side effect that can occur because of the preservative metacresol is inflammation of the muscles near the injection site. If your doctor confirms that you have developed this, you should use a Genotropin product without metacresol.

Slipped capital femoral epiphysis and Legg-Calve-Perthes disease may be considered by your doctor if discomfort or pain in the hip or knee is experienced whilst being treated with Genotropin.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking Genotropin, contact your doctor or treatment center.

HOW TO STORE IT

Keep out of the reach and sight of children.

Do not use Genotropin after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Before mixing the powder with the liquid, your growth hormone should be stored in a refrigerator (2° to 8°C) until no later than the expiry date. It can be stored for a maximum of 4 weeks unrefrigerated (at or below 25 C). During and/or at the end of the 4 weeks period, the product should not be put back in the refrigerator. After this it must be discarded.

Genotopin is sensitive to light. You should keep the GoQuick pen in the outer carton in order to protect your Genotropin from light.

After mixing the powder with the liquid, Genotropin must be stored in a refrigerator (2° to 8°C), for up to 4 weeks. If you use the needle guard, store your pen with the needle guard and black cap in place. If you do not use the needle guard, store your pen with the white pen cap in place. See the Instructions for Use. These measures will help to protect your Genotropin from light.

Do not freeze or expose Genotropin to frost. If it freezes, do not use it.

Never throw away needles with your ordinary garbage. When you have finished with a needle, you must discard it carefully

so that no-one will be able to use it or prick themselves on it. You can get a special “sharps” bin from your hospital or growth clinic.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

————————————————————————– Report online at www.healthcanada.gc.ca/medeffect Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and: – Fax toll-free to 1-866-678-6789, or

– Mail to:

Canada Vigilance Program

Health Canada

Postal Locator 0701D

Ottawa, Ontario

K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health

professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at www.pfizer.ca or can be obtained by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001 (Medical Information)

This leaflet was prepared by Pfizer Canada Inc. Last revised: 23 December 2014

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

PrOMNITROPE®

AWM nee trope

(Somatropin for Injection)

Lyophilized powder: 5.8 mg/vial

Read this carefully before you start taking Omnitrope and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about Omnitrope.

Omnitrope is a biosimilar biologic drug (biosimilar) to the reference biologic drug Genotropin®. A biosimilar is authorized based on its similarity to a reference biologic drug that was already authorized for sale.

Serious Warnings and Precautions

∙ A doctor trained in hormone and growth disorders must examine the patient to decide if it is safe to use Omnitrope.

∙ After the Omnitrope powder has been dissolved it must be water-clear and free of particles.

What is Omnitrope used for?

In children, Omnitrope is used to treat the following growth problems:

∙ If you are not growing properly and you do not have enough of your own growth hormone.

∙ If you have Turner syndrome. Turner syndrome is a chromosomal error in girls that can affect growth – your doctor will have told you if you have this.

∙ If you were small or too light at birth. Growth hormone may help you grow taller if you have not been able to catch up or maintain normal growth by two years of age or later.

∙ If you have idiopathic (unknown cause) short stature.

In adults, Omnitrope is used to treat persons with pronounced growth hormone deficiency. This can start during adult life, or it can continue from childhood.

If you have been treatedwith Omnitrope for growth hormone deficiency during childhood, your growth hormone status will be retested after completion of growth. If severe growth hormone deficiency is confirmed, your doctor will propose continuation of Omnitrope treatment.

How does Omnitrope work?

Omnitrope is a recombinant human growth hormone (also called somatropin). It has the same structure as natural human growth hormone which is needed for bones and muscles to grow. It also

OMNITROPE (somatropin for injection)

helps your fat and muscle tissues to develop in the right amounts. Recombinant means it is made using bacteria instead of being taken out of human or animal tissue.

What are the ingredients in Omnitrope?

Medicinal ingredient: Somatropin (recombinant human growth hormone)

Non-medicinal ingredients:

Omnitrope Lyophilized Powder: Glycine, disodium hydrogen phosphate, sodium dihydrogen phosphate.

Diluent Cartridge: Bacteriostatic Water for Injection USP (benzyl alcohol preserved)

Omnitrope comes in the following dosage forms:

Omnitrope (somatropin for injection) is supplied as follows: Lyophilized powder: 5.8 mg/vial.

Do not use Omnitrope if:

∙ You are allergic (hypersensitive) to somatropin or any of the other ingredients of Omnitrope. ∙ You have an active tumour. Tumours must be inactive and you must have finished your anti tumour treatment before you start using Omnitrope.

∙ You are seriously ill (for example, complications following open heart surgery, abdominal surgery, acute respiratory failure, accidental trauma or similar conditions). If you are about to have, or have had, a major operation, or go into hospital for any reason, tell your doctor and remind the other doctors you are seeing that you use growth hormone.

∙ Omnitrope has been prescribed to stimulate growth but you have already stopped growing (the growth plates on your long bones are closed).

∙ In patients with diabetic retinopathy, a complication of diabetes that results from damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina).

∙ If you or your child are allergic to benzyl alcohol.

∙ You have uncontrolled diabetes or active psychosis.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Omnitrope. Talk about any health conditions or problems you may have.

Omnitrope therapy should be carried out under the regular guidance of a doctor who is experienced in the diagnosis and management of patients with growth hormone deficiency.

BEFORE you use Omnitrope talk to your doctor or pharmacist:

∙ If the patient is at risk of developing diabetes, the doctor will need to monitor their blood sugar level during treatment with Omnitrope.

∙ If the patient has diabetes, they should closely monitor their blood sugar level during treatment with Omnitrope and discuss the results with their doctor to determine whether they need to change the dose of their medicines to treat diabetes.

∙ If the patient is receiving treatment with thyroid hormones it may be necessary to adjust their thyroid hormone dose.

OMNITROPE (somatropin for injection)

∙ If the patient is taking growth hormone to stimulate growth and walk with a limp or if they start to limp during their growth hormone treatment due to pain in their hip, they should inform their doctor.

∙ If the patient develops a strong headache, visual disturbances or vomiting they should inform their doctor about it.

∙ If the patient is receiving Omnitrope for growth hormone deficiency following a previous tumour, they should be examined regularly for recurrence of the tumour.

∙ If the patient is a survivor of childhood cancer.

∙ If the patient, especially a child, develops severe abdominal pain (inflammation of the pancreas).

∙ If the patient is, or plans to become pregnant or is breastfeeding.

∙ If the patient develop a limp while being treated with Omnitrope.

∙ If the patient has Turner syndrome and develops an ear infection or headaches her doctor should be told about these problems.

∙ If the patient has hypopituitarism and is receiving standard hormone replacement therapy, the doctor should monitor the hormone replacement therapy closely during Omnitrope treatment. ∙ If you or your child are allergic to benzyl alcohol. Omnitrope 5.8 mg/vial Lyophilized Powder requires reconstitution with a diluent that contains benzyl alcohol.

After starting Omnitrope treatment some patients may need to start thyroid hormone replacement.

Progression of pre-existing scoliosis (curvature of the spine) can occur in children who have rapid growth.

The patient should not use Omnitrope if they are pregnant or are trying to become pregnant.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Omnitrope:

You should tell your doctor if you are using:

∙ medicines to treat diabetes,

∙ thyroid hormones,

∙ synthetic adrenal hormones (corticosteroids),

∙ sex hormones (for example oral estrogens),

∙ cyclosporine (a medicine that weakens the immune system after transplantation), ∙ medicines to control epilepsy (anticonvulsants).

Your doctor may need to adjust the dose of these medicines or the dose of Omnitrope.

How to take Omnitrope:

Recommended dosage

The dose depends on your size, the condition for which you are being treated and how well growth hormone works for you. Everyone is different. Your doctor will advise you about your individualized dose of Omnitrope in milligrams (mg) from either your body weight in kilograms (kg), as well as your treatment schedule. Do not change the dosage and treatment schedule without consulting your doctor.

OMNITROPE (somatropin for injection)

Children with growth hormone deficiency:

0.16-0.24 mg/kg body weight per week. Higher doses can be used. When growth hormone deficiency continues into adolescence, Omnitrope should be continued until completion of physical development.

Children with Turner syndrome:

0.33 mg/kg body weight per week.

Children with idiopathic short stature:

UP TO 0.47 mg/kg body weight per week

Children born smaller or lighter than expected and with growth disturbance:

UP TO 0.48 mg/kg body weight per week. Your doctor will determine the most appropriate dose and length of treatment. Treatment should be discontinued if: i) after the first year if you are not responding or ii) if you have reached your final height and stopped growing.

Adults with growth hormone deficiency:

You should start with 0.15-0.3 mg per day.

This dosage should be gradually increased or decreased according to blood test results as well as clinical response and side effects.

Follow the instructions given to you by your doctor

Injecting Omnitrope

Omnitrope is intended for subcutaneous use. This means that it is injected through a short injection needle into the fatty tissue just under your skin. Your doctor should have already shown you how to use Omnitrope. Always inject Omnitrope exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

If you use more Omnitrope than you should

If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or “not yourself”, and you might faint.

If you forget to use Omnitrope

Do not use a double dose to make up for a forgotten dose. It is best to use your growth hormone regularly. If you forget to use a dose, have your next injection at the usual time the next day. Keep a note of any missed injections and tell your doctor at your next check-up.

If you stop using Omnitrope

Ask for advice from your doctor before you stop using Omnitrope.

If you have any further questions on the use of this product, ask your doctor or pharmacist. Overdose:

OMNITROPE (somatropin for injection)

If you think you, or a person you are caring for, have taken too much Omnitrope, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

Missing injections can interfere with the effectiveness of the medication. Talk to your doctor if this should happen. Do not try to make up for missed injections by “doubling up” on injections.

Note: Do not reconstitute Omnitrope or inject it, until you have been taught the proper technique by your healthcare provider and you understand the instructions. Ask your healthcare provider or pharmacistif you have any questions about injecting Omnitrope.

PREGNYL® B

chorionic gonadotropin Human Gonadotropin Organon DIN(s): 02182904

Date of Revision: March 30, 2021

Pharmacology

The action of human chorionic gonadotropin (hCG) is virtually identical to that of pituitary LH, although hCG appears to have a small degree of FSH activity as well. It stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone.

Androgen stimulation in the male leads to the development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment to descent is present.

hCG has no known effect on fat mobilization, appetite or sense of hunger, or body fat distribution. Following IM administration, an increase in serum chorionic gonadotropin concentrations may be observed within 2 hours. Peak concentrations occur within 6 hours and persist for approximately 36 hours. Serum chorionic gonadotropin levels begin to decline at 48 hours reaching undetectable levels after 72 hours. Chorionic gonadotropin is distributed primarily in the testes and ovaries of the male and female respectively, with small amounts possible distributing into the proximal tubules of the renal cortex.

Blood levels of chorionic gonadotropin decline in a biphasic manner. The initial phase half-life has been reported between 5.6 and 11 hours, whereas the terminal phase half-life has been reported between 23 and 37.2 hours. Following IM administration of therapeutic doses, approximately 10-12% of the dose is excreted in urine within 24 hours.

Indications

Pregnyl (chorionic gonadotropin for injection, USP) is indicated for:

Prepubertal cryptorchidism not due to anatomical obstruction. In general, hCG is thought to induce testicular descent in situations when descent would have occurred at puberty. hCG thus may help predict whether or not orchiopexy will be needed in the future.
Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.
Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with FSH-containing preparations.

NOTE: hCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or “normal” distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.

Contraindications

Pregnyl (chorionic gonadotropin for injection, USP) is contraindicated for prepubertal boys with signs of anatomical obstruction and for patients with:

Precocious puberty.
Hypersensitivity to this drug or to any ingredient in the formulation or component of the container (see Warnings and Precautions).
Known or suspected sex hormone-dependent tumours, such as ovary, breast and uterine carcinoma in female and prostatic or breast carcinoma in the male.
Malformations of the reproductive organs incompatible with pregnancy.
Fibroid tumours of the uterus incompatible with pregnancy.
Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.

Warnings

hCG should be used in conjunction with FSH-containing preparations only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings and precautions, and adverse reactions described in the package insert for FSH-containing preparations.

The drug substance of this product is manufactured from human urine. Although the risk is theoretical, and no case of transmission of an infectious agent linked to the use of urine-derived gonadotropins has ever been identified, the risk of transmitting infectious agents cannot be completely excluded.

Anaphylaxis and other hypersensitivity reactions have been reported with urinary derived hCG products.

For Males and Females

Hypersensitivity Reactions

Hypersensitivity reactions, both generalized and local; anaphylaxis; and angioedema have been reported. If a hypersensitivity reaction is suspected, discontinue Pregnyl and assess for other potential causes for the event. (See )

General

Patients should be evaluated for uncontrolled non-gonadal endocrinopathies (e.g. thyroid, adrenal or pituitary disorders) and appropriate specific treatment given.
Pregnyl should not be used for body weight reduction. hCG has no effect on fat metabolism, fat distribution or appetite.

In the Female

Multi-Fetal Gestation and Birth

In pregnancies occurring after induction of ovulation with gonadotropic preparations, there is an increased risk of multiple pregnancies.

Ectopic Pregnancy

Infertile women undergoing Assisted Reproductive Technologies (ART) have an increased incidence of ectopic pregnancy. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.

Pregnancy Loss

Rates of pregnancy loss in women undergoing assisted reproductive technologies (ART) are higher than in the normal population.

Congenital Malformations

The incidence of congenital malformations after assisted reproductive technologies may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multiple gestations after assisted reproductive technologies. There are no indications that the use of gonadotropins during assisted reproductive technologies is associated with an increased risk of congenital malformations.

Ovarian Hyperstimulation Syndrome (OHSS)

OHSS is a medical event distinct from uncomplicated ovarian enlargement. Clinical signs and symptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhea, mild to moderate enlargement of ovaries and ovarian cysts. Severe OHSS may be life-threatening. Clinical signs and symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, hydrothorax, dyspnea, oliguria, hematological abnormalities and weight gain. In rare instances, venous or arterial thromboembolism may occur in association with OHSS. Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy have also been reported in association with OHSS.

Adherence to the recommended Pregnyl dose and treatment regimen is advised. Care should be taken with the administration of Pregnyl because OHSS may be triggered by administration of human Chorionic Gonadotropin (hCG). OHSS may also be triggered by pregnancy (endogenous hCG). Early OHSS usually occurs within 10 days after hCG administration and may be associated with an excessive ovarian response to gonadotropin stimulation. Late OHSS occurs more than 10 days after hCG administration, as a consequence of the hormonal changes with pregnancy. Because of the risk of developing OHSS, patients should be monitored for at least two weeks after hCG administration.

Women with known risk factors for a high ovarian response may be especially prone to the development of OHSS during or following treatment with Pregnyl. For women having their first cycle of ovarian stimulation, for whom risk factors are only partially known, close observation for early signs and symptoms of OHSS is recommended.

Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive Technology (ART). Careful monitoring of ovarian response is important to reduce the risk of OHSS. To monitor the risk of OHSS, ultrasonographic assessments of follicular development should be performed prior to treatment and at regular intervals during treatment, the concurrent determination of serum estradiol levels may also be useful. In ART, there is an increased risk of OHSS with 18 or more follicles of 11 mm or more in diameter.

For patients at increased risk of OHSS or if OHSS develops, standard and appropriate management of OHSS should be implemented and followed.

Ovarian Torsion

Ovarian torsion has been reported after treatment with gonadotropins, including Pregnyl. Ovarian torsion may be related to other conditions, such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, and previous or current ovarian cysts. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.

Vascular Complications

Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including Pregnyl. Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities. Women with generally recognised risk factors for thrombosis, such as a personal or family history, severe obesity or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins. In these women the benefits of IVF treatment need to be weighed against the risks. It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis.

In the Male

Antibody Formation

Administration of hCG can provoke the formation of antibodies against hCG. In rare cases, this may result in an ineffective treatment.

Treatment with hCG Leads to Increased Androgen Production. Therefore

Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy, migraine or asthma (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced as a result of increased androgen production.
hCG should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly.

Neurologic

As far as known this medicine has no influence on alertness and concentration.

Special Populations

Pregnancy

Pregnyl should not be used after pregnancy is established. Lactation

Pregnyl must not be used during lactation.

Precautions Drug Interactions

Interactions of Pregnyl (chorionic gonadotropin for injection, USP) with other medicines have not been investigated; interactions with commonly used medicinal products can therefore not be excluded.

Following administration, Pregnyl may interfere for up to ten days with the immunological determination of serum/urinary hCG, leading to a false positive pregnancy test.

Adverse Effects

Adverse Drug Reaction Overview

Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia as well as pain at the injection site have been reported during treatment with Pregnyl (chorionic gonadotropin for injection, USP). Ovarian cancer has also been reported in a very small number of infertile women who have been treated with fertility drugs. A causal relationship between treatment with fertility drugs and ovarian cancer has not been established.

Clinical Trial Adverse Drug Reactions

Clinical trials are conducted under very specific conditions and therefore, the adverse drug reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another member of the therapeutic class. Frequencies of adverse drug reactions from clinical trials with Pregnyl is not available because that information was not being collected by the system used in current drug development.

Post-Market Adverse Drug Reactions

General Disorders and Administrative Site Conditions

Pregnyl may cause reactions at the site of injection, such as bruising, pain, redness, swelling and itching. Occasionally allergic reactions have been reported, mostly manifesting as pain and/or rash at the injection site. Weight gain has been observed as part of the clinical picture of severe OHSS.

Immune System Disorders

In rare cases generalized rash or fever may occur.

In the Female

Gastrointestinal Disorders

abdominal pain and gastrointestinal symptoms such as nausea and diarrhea, related to mild OHSS. Ascites, as a complication of severe OHSS.

Reproductive and Breast Disorders

unwanted ovarian hyperstimulation, mild or severe OHSS (see Warnings and Precautions). Painful breasts, mild to moderate enlargement of ovaries and ovarian cysts related to mild OHSS. Large ovarian cysts (prone to rupture), usually associated with severe OHSS.

Respiratory. Thoracic and Mediastinal Disorders

hydrothorax, as a complication of severe OHSS.

Vascular Disorders

In rare instances, thromboembolism has been associated with FSH/hCG therapy, usually associated with severe OHSS (see Warnings and Precautions).

In the Male

Metabolism and Nutrition Disorders

Water and sodium retention is occasionally seen after administration of high dosages; this is regarded as a result of excessive androgen production.

Reproductive System and Breast Disorders

hCG treatment may sporadically cause gynecomastia.

Overdose

For management of a suspected drug overdose, contact your regional Poison Control Centre. See the CPS Directory section for a list of Poison Control Centres.

Dosage

FOR INTRAMUSCULAR USE ONLY after reconstitution of the dry powder with the sterile diluent. Although the dosac regimen will depend upon the indication, the patient’s age and weight, and the preserver’s preference, the following regimens have been advocated by various authorities.

Males

Prepubertal Cryptorchidism Not Due to Anatomical Obstruction

4000 USP units, 3 times weekly, for 2 to 3 weeks, or 1000 USP units, 3 times weekly for 6 to 8 weeks. The dosage schedule may vary to some extent, depending upon the age when treatment is given. If the dosage is adequate, there will usually be some indication, following one such course of therapy, whether descent will occur or surgery be required.

A therapeutic trial with chorionic gonadotropin may constitute a valuable diagnostic aid to determine the need for surgery. Lack of response is usually an indication of anatomic obstruction. Furthermore, when surgery is required, the preliminary treatment may facilitate the procedure by increasing the size of the testes and the length of the cords. Postoperative gonadotropic therapy has also been suggested to prevent retraction of testes.

Age of initiation of treatment: Various ages ranging from early childhood to immediately before expected puberty have been suggested. The average appropriate age, however, appears to be 12 years.

Selected Cases of Hypogonadotropic Hypogonadism in Males

4000 to 5000 USP units 3 times weekly for 6 to 8 weeks with a rest of period of 2 to 3 weeks between courses of therapy.

Females

Induction of ovulation and pregnancy in the anovulatory infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately pretreated with FSH-containing preparations (see prescribing information of FSH-containing preparations for dosage and administration for those drug products).

5000 to 10 000 USP units one day following the last day of treatment with an FSH-containing preparation (a dosage of 10 000 USP units is recommended in the labeling of FSH-containing preparations).

Stability and Storage Recommendations

Store at 15-30°C.

Reconstituted solution is stable for 28 days when refrigerated (2-8°C).

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Reconstituted Solution

Direction for Reconstitution

Reconstitute Pregnyl 10 000 USP units to the desired concentration by addition of the required amount of the solvent supplied. Remove 1 to 10 ml. of the solvent and add to the vial with the lyophilized Pregnyl, agitate gently until the powder is completely dissolved.

When reconstituted with 10 ml_ of the solvent, the concentration of Chorionic Gonadotropin is 1000 USP units/mL. The solvent contains 0.9% benzyl alcohol.

Supplied

Each vial of Pregnyl contains: 10 000 USP units of sterile lyophilized human chorionic gonadotropin plus 5 mg of monobasic sodium phosphate monohydrate and 4.4 mg of dibasic sodium phosphate anhydrous (pH may have been adjusted with sodium hydroxide and/or phosphoric acid). Each vial of Pregnyl solvent contains: 10 ml_ of Water for Injection, 0.9% of benzyl alcohol, 0.56% sodium chloride and trace amount of sodium hydroxide and/or hydrochloric acid. Packages of 2 vials: one multi-dose vial of Pregnyl (chorionic gonadotropin for injection, USP) 10 000 USP units plus one vial of 10 ml_ sterile Pregnyl solvent.

This product monograph was developed by the pharmaceutical manufacturer in accordance with the requirements of Health Canada. CPhA recommends that the full monograph be used. Partial monographs should not be provided to patients or anyone else and are for use only by clients at their own risk. CPhA assumes no responsibility for or liability in connection with the use of this monograph. Once printed, there is no guarantee the information is up-to-date. [Printed on: 09-23-2024 12:22 PM]

Testosterone Enanthate Injection, USP IMPORTANT: PLEASE READ

This leaflet is part III of a three-part “Prescribing Information” and is designed specifically for Consumers.

This leaflet is a summary and will not tell you everything about Testosterone Enanthate Injection, USP. Contact your doctor or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor has prescribed this medicine because your body is not making enough testosterone. The medical term for this condition is hypogonadism.

What it does:

Testosterone Enanthate Injection, USP delivers medicine into your bloodstream by intramuscular injection. Testosterone Enanthate Injection, USP helps raise your testosterone to normal levels.

When it should not be used:

If you have or it is suspected that you have prostate or breast cancer.
If you have difficulty in urinating due to an enlarged prostate.
If you have known allergy to any of its components [the active ingredient is testosterone, which may be synthesized from soy; (see “What the nonmedicinal ingredients are” in this section)]

Testosterone Enanthate Injection, USP should NOT be used by women. Pregnant and breast feeding women are especially at risk. Testosterone may cause harm to your unborn baby.

What the medicinal ingredient is:

testosterone enanthate

What the nonmedicinal ingredients are:

sesame oil

chlorobutanol

What dosage formsit comes in:

A 200 mg/mL solution for intramuscular injection.

WARNINGS AND PRECAUTIONS

There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.

Testosterone Enanthate Injection, USP is not recommended for use in children < 18 years of age.

You should not use testosterone in an attempt to reduce weight

Before using Testosterone Enanthate Injection, USP, talk to your doctor if you:

have difficulty urinating due to an enlarged prostate. Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;
have prostate cancer (confirmed or suspected);
have heart or blood vessel problems or a history of these problems such as heart attacks, stroke, or blood clot in the lungs or legs;
have liver or kidney;
have high blood pressure (hypertension); have diabetes; • have breathing problems during sleep (sleep apnea).

Drug Abuse and Dependence:

Testosterone Enanthate Injection, USP contains testosterone, which is a controlled substance under Schedule G of the Food and Drugs Act.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription.

Drugsthat may interact with Testosterone Enanthate Injection, USP include:

Insulin
Corticosteroids
Propranolol
Warfarin

PROPER USE OF THIS MEDICATION Usual Dose:

The usual dose is 100-400 mg every four weeks.

What should I do if I miss a dose of Testosterone Enanthate Injection, USP? If you missed a dose, you should consult your health care provider (physician).

What should I do in case of overdose?

If you think you, or a person you are caring for, have taken too much Testosterone Enanthate Injection, USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Testosterone Enanthate Injection

IMPORTANT: PLEASE READ

Never share your Testosterone Enanthate Injection, USP with anyone.

Every patient is different. Your doctor has prescribed Testosterone Enanthate Injection, USP specifically for your needs. To get the best results from Testosterone Enanthate Injection, USP, it is essential that you take it exactly as your doctor has prescribed.

Use Testosterone Enanthate Injection, USP only for the condition for which it was prescribed. If you have any questions or concerns about Testosterone Enanthate Injection, USP treatment, ask your health care provider or pharmacist. They can answer your questions and may be able to give you additional printed information about Testosterone Enanthate Injection, USP.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Testosterone Enanthate Injection, USP can have side effects. The following side effects have been reported for products containing testosterone:

increased or irregular heart rate, blood clot in the lungs or legs;
skin irritation or redness or rash at the application site; • increased prostatic specific antigen (PSA);
enlarged prostate (benign prostatic hyperplasia); • an increase in red blood cell count (hematocrit and hemoglobin);
acne;
change in mood, depression; prolonged or painful erection; • sleep disturbances caused by breathing problems; • aggression or aggressive behaviour;
breast enlargement and breast pain;
loss of hair and baldness;
high blood pressure;
weight gain;
headache,
dizziness.

This is not a complete list of side effects. For any unexpected effects while taking Testosterone Enanthate Injection, USP, contact your doctor or pharmacist.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Serious side effects and what to do about them
Symptom/Effect		Talk to your Health Care professional		Stop taking drug and get immediate medical help
Symptom/Effect		Only if severe	In all cases
Common	Urinary symptoms (i.e. change in frequency/color , dribbling, pain on urination straining, weak stream, small amounts)		✓
Common (after prolonged use)	Breast enlargement or breast pain		✓
Uncommon	Heart attack and stroke			✓
Uncommon	Swelling of ankles and legs (in patients with heart, kidney or liver damage)			✓
Uncommon	Erectionsthat are too frequent or continue for too long		✓
Uncommon	Liver problems, with symptoms such as nausea, vomiting, along with yellowed or darkened skin			✓

Testosterone Enanthate Injection

HOW TO STORE IT

IMPORTANT: PLEASE READ

Testosterone Enanthate Injection, USP should be stored at controlled room temperature between 15°C and 30°C.

Keep out of reach of children and pets.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health

canada/services/drugs-health

products/medeffect-canada/adverse-reaction

reporting.html ) for information on how to

report online, by mail or by fax;or

Calling toll-free at1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION If you want more information about Testosterone Enanthate Injection, USP:

Talk to your healthcare professional
Find the full product monograph that is

prepared for healthcare professionals and

includes this Patient Medication Information

by visiting the Health Canada website:

(https://www.canada.ca/en/health

canada/services/drugs-health-products/drug

products/drug-product-database.html the

manufacturer’s website

https://www.hikma.com, or by calling 1-800-

656-0793.

This leaflet was prepared by Hikma Canada Limited, 5995 Avebury Road, Suite 804, Mississauga, ON L5R 3P9. Importer / Distributor: Innomar Strategies Inc., 8030 Esquesing Line, Milton, ON L9T 6W3.

Last revised: March 17, 2023.

What it does:

DEPO-TESTOSTERONE delivers testosterone into the bloodstream through an injection into your gluteal muscle. DEPOTESTOSTERONE helps raise your testosterone to normal levels.

When it should not be used:

if you have prostate or breast cancer (confirmed or suspected by your doctor)
if you have difficulty in urinating due to an enlarged prostate
if you have a known allergy or sensitivities to any of the ingredients contained in DEPO-TESTOSTERONE, including testosterone USP that is chemically synthesized from soy (see “What the medicinal and nonmedicinal ingredients are” in this section).

DEPO-TESTOSTERONE should NOT be used by women. Pregnant and breast-feeding women are especially at risk. Testosterone may cause harm to your unborn baby.

What the medicinal ingredient is:

Testosterone cypionate

What the nonmedicinal ingredients are:

Benzyl alcohol, benzyl benzoate, and cottonseed oil

What dosage forms it comes in:

DEPO-TESTOSTERONE is available in one strength, 100 mg

testosterone cypionate /mL.

DEPO-TESTOSTERONE is available in the following packaging:

100 mg per mL – In vials of 10 mL.

WARNINGS AND PRECAUTIONS

There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.

DEPO-TESTOSTERONE is not recommended for use in children < 18 years of age.

DEPO-TESTOSTERONE can cause changes in your vision. It is called chorioretinopathy.

You should not use testosterone in an attempt to reduce weight and increase muscle, or improve athletic performance as it may cause serious health problems.

You should not use testosterone to treat sexual dysfunction or male infertility.

DEPO-TESTOSTERONE contains benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome” (difficulty in catching breath, low blood pressure, slow heart rate), and death in pediatric patients. Premature and low-birth weight infants may be more likely to develop toxicity.

Pregnancy: Benzyl alcohol can cross the placenta.

Before using DEPO-TESTOSTERONE, talk to your doctor if you:

have difficulty urinating due to an enlarged prostate.

Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;

have prostate cancer (confirmed or suspected);
have liver, kidney or heart disease;
have high blood pressure (hypertension);
have diabetes;
have breathing problems during sleep (sleep apnea);
have heart or blood vessels problems or a history of these problems such as heart attack, stroke, or blood clots in the lungs or the legs.

Drug Abuse and Dependence: DEPO-TESTOSTERONE contains testosterone. Testosterone is a controlled substance because some people take it in high doses (abuse it), even if their body is making enough testosterone. Taking too much (abusing) testosterone can cause serious health problems, which can even lead to death (see Overdose).

Individuals who have abused testosterone may experience withdrawal symptoms lasting for weeks or months which include, but are not limited to: changes in mood, and appetite, as well as fatigue, insomnia, decreased sex drive and loss of function of the testes and ovaries.

Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription.

Drugs that include:

Insulin
Corticosteroids
Propranolol
Warfarin

PROPER USE OF THIS MEDICATION

DEPO-TESTOSTERONE should only be administered by a health care professional.

When you are given DEPO-TESTOSTERONE, your blood testosterone should be checked on a regular basis.

Usual dose: 200 mg is given intramuscularly (in the muscle) every two weeks.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. Taking too much (abusing) testosterone for a long time can cause serious health problems, which can even lead to death. Some of the health problems include effects on the cardiovascular system, reproductive system and the liver, as well as serious psychiatric problems.

Missed Dose:

If you have missed a dose of DEPO-TESTOSTERONE, you should contact your doctor to schedule your next injection.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, DEPO-TESTOSTERONE can have side effects. The following side effects have been reported for testosterone products:

skin irritation or redness or rash at the application site;
increased prostatic specific antigen (PSA);
enlarged prostate (benign prostatic hyperplasia);
an increase in red blood cell count, (hematocrit and hemoglobin);
acne;
change in mood, depression;
prolonged or painful erection;
sleep disturbances caused by breathing problems;
aggression or aggressive behaviour;
breast enlargement and breast pain;
loss of hair and baldness;
high blood pressure;
weight gain;
headache, dizziness;
increased or irregular heart rate, blood clot in the lungs or the legs;

This is not a complete list of side effects. For any unexpected effects while taking DEPO-TESTOSTERONE, contact your doctor or pharmacist.

IMPORTANT SAFETY INFORMATION FOR TESTOSTERONE 1% GEL

What it does:

TESTOSTERONE 1% GEL delivers medicine into your bloodstream through your skin. TESTOSTERONE 1% GEL helps raise your testosterone to normal levels.

When it should not be used:

If you have or it is suspected that you have prostate or breast cancer.
If you have a known allergy to any of its components [the active ingredient is testosterone, which may be synthesized from soy; (see “What the non-medicinal ingredients are” in this section)].

TESTOSTERONE 1% GEL should NOT be used by women. Pregnant and breast-feeding women are especially at risk and should avoid skin contact with application sites on men. Testosterone may cause harm to your unborn baby. Testosterone exposure during pregnancy has been reported to be associated with fetal abnormalities. If skin contact with unwashed or unclothed application sites of men using TESTOSTERONE 1% GEL and/or with clothing or other fabrics exposed to TESTOSTERONE 1% GEL occurs, pregnant or nursing women should immediately wash the area of contact with soap and water.

What the medicinal ingredient is:

Testosterone USP

What the non-medicinal ingredients are:

Alcohol, purified water, sodium hydroxide, Carbopol 980 and isopropyl myristate.

What dosage forms it comes in:

TESTOSTERONE 1% GEL is a gel containing 1% testosterone. It is supplied either in a pump or foil packets:

One 2.5 g packet contains 25 mg of testosterone
One 5.0 g packet contains 50 mg of testosterone
One full press of the pump delivers 1.25 g of gel which contains 12.5 mg of testosterone.

WARNINGS AND PRECAUTIONS:

Serious Warnings and Precautions:

TESTOSTERONE 1% GEL can be transferred to another person when skin-to-skin contact with application site occurs.

Signs of puberty (unexpected sexual development) have been reported in children who were exposed to testosterone gel.
Keep children away from unwashed or unclothed application sites of men using TESTOSTERONE 1% GEL and from unwashed clothing or other fabrics exposed to TESTOSTERONE 1% GEL.
Men who use TESTOSTERONE 1% GEL must strictly follow the instructions for use to lower the risk of transferring TESTOSTERONE 1% GEL to another person.

You should prevent TESTOSTERONE 1% GEL from transferring to another person, especially pregnant or breast-feeding women, or children by taking the following precautions:

Children and women should avoid contact with the application sites on men using TESTOSTERONE 1% GEL.
TESTOSTERONE 1% GEL should be applied only to the areas of the shoulders, upper arms, and/or abdomen that will be covered by a short sleeve T-shirt.
Wash hands immediately with soap and water after application of TESTOSTERONE 1% GEL.
Cover the application site(s) with clothing (such as a shirt) after TESTOSTERONE 1% GEL has dried.
If direct skin-to-skin contact is anticipated, wash the application site(s) thoroughly with soap and water to remove any TESTOSTERONE 1% GEL left on the application site(s).
In the event that an unwashed or uncovered TESTOSTERONE 1% GEL application site and/or unwashed clothing or other fabrics exposed to TESTOSTERONE 1% GEL does come in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.