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

About this medication

What the medication is used for:

You have been prescribed PLAVIX because you are at risk for experiencing unwanted blood clots (thrombi). These blood clots can lead to symptoms which present in different manners, such as strokes, unstable angina, heart attacks, or peripheral arterial disease (leg pain on walking or at rest). PLAVIX is taken to prevent further blood clots from forming thereby reducing the risk of having unstable angina, a heart attack or another stroke.

Your doctor can also prescribe PLAVIX for you if you have an irregular heartbeat, a condition called ‘atrial fibrillation’, and you cannot take medicines known as ‘oral anticoagulants’ (for example, warfarin) which prevent new clots from forming and prevent existing clots from growing. You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid (ASA) or the combined use of Plavix and ASA for this condition. Your doctor should have prescribed Plavix plus ASA if you cannot take ‘oral anticoagulants’ as the combined use of Plavix plus ASA is more effective than ASA alone.

Be sure to talk to your doctor before taking PLAVIX if you have an elevated risk of bleeding.

This product has been prescribed for you personally and you should not pass it on to others.

What it does:

PLAVIX tablets belong to a group of medicines called antiplatelet drugs. Platelets are very small structures in blood, smaller than red or white blood cells, which clump together during blood clotting. By preventing this clumping, antiplatelet drugs reduce the chances of blood clots forming (a process called thrombosis).

When it should not be used:

• If you are allergic to any of the substances contained in the tablets (see below).
• If you have a medical condition that is causing bleeding, such as a stomach ulcer.
• If you have liver disease or damage.

What the medicinal ingredient is:

Clopidogrel bisulfate

What the nonmedicinal ingredients are:

low substituted hydroxypropylcellulose, mannitol, microcrystalline cellulose, polyethylene glycol 6000, and hydrogenated castor oil. The pink film coating contains lactose, hypromellose, titanium dioxide, triacetin and red iron oxide. The tablets are polished with carnauba wax.

What dosage forms it comes in:

PLAVIX comes as 75 mg and 300 mg tablets. PLAVIX 75 mg tablets are round, pink and engraved on one side with the number 75 and the number 1171 on the other side. PLAVIX 300 mg tablets are oblong, pink and engraved on one side with the number 300 and the number 1332 on the other side.

Warnings & Precautions

BEFORE you use PLAVIX talk to your doctor or pharmacist if:

• You have had an allergic reaction to any of the substances contained in the tablets.
• You have a medical condition that is causing bleeding, such as a stomach ulcer.
• You are taking any other medications (such as acetylsalicylic acid (ASA), other drugs used to reduce blood clotting such as warfarin and heparin or Non-Steriodal Anti-Inflammatory Drugs [NSAIDS; drugs used to treat painful and/or inflammatory conditions of muscles or joints]), including those that you buy without a prescription.
• You are taking drugs used to treat stomach ulcers and stomach acidity  (e.g. omeprazole).
• You are pregnant or become pregnant on PLAVIX, or you are breast-feeding.
• You have a recent serious injury.
• You have liver disease or damage.
• You have recently undergone surgery (including dental surgery).
• You will be having surgery. Your doctor may ask you to stop taking PLAVIX for 5-7 days before your surgery.
• You have a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body) or tend to bleed longer than 10 minutes without taking any drugs.

While you are on PLAVIX and you experience any excessive bleeding, do not stop taking PLAVIX but see or call your doctor right away.

While you are on PLAVIX it is important that you do not take any medicine other than that prescribed by your doctor. If you should see another doctor or a dentist while you are using PLAVIX, you should inform them that you are using PLAVIX.

Interactions with this medication

Drugs that may interact with PLAVIX include: ASA, NSAIDS, heparin, warfarin, digoxin, theophylline, antacids (e.g. omeprazole).

Proper use of this medication

Usual dose:

Adults (including the elderly):
You should take one 75 mg tablet of PLAVIX per day, by mouth. PLAVIX can be taken with or without food. You should take your medicine regularly and at the same time each day. If you have had unstable angina or a heart attack, a one-time 300 mg dose may be administered followed by one 75 mg tablet daily.

If you have atrial fibrillation, the usual dose is PLAVIX 75 mg once daily in combination with ASA 75-100 mg once daily.

Children and adolescents:
PLAVIX is not recommended for children or adolescents below 18 years of age.

PLAVIX should be taken long term under supervision of your doctor.

Overdose:

A large dose of tablets could put you at risk of serious bleeding, requiring emergency treatment.

Missed Dose:

If you forget to take a dose of PLAVIX, but remember within 12 hours of your usual time, take your tablet immediately and then take your next tablet at the normal time. If you forget for more than 12 hours simply take the next single dose at the usual time. Do not take a double dose to make up for the one you missed. You can check the day on which you last took a tablet of PLAVIX by referring to the calendar printed on the blister strip.

Side effects and what to do about them

Occasional side effects reported with PLAVIX are:

• Rashes and/or itching
• Diarrhea
• Abdominal pain
• Indigestion or heartburn
• Constipation
• Bleeding in the stomach, bowels or into the eye
• Hepatic (liver) and biliary (bile) disorders
• Blood in the urine (haematuria)
• Generalized allergic reactions such as swelling of the face, lips and/or tongue, shortness of breath
• Bleeding from blood vessels inside the head has been reported in a very small number of cases
• In very rare cases, joint pain and/or muscle pain are reported
• Fever, signs of infection or extreme tiredness. This may be due to rare decrease of some blood cells
• Signs of liver problems such as yellowing of the skin and/or eyes (jaundice), whether or not associated with bleeding and/or confusion

If you notice any undesirable effects, especially during the first few weeks of treatment, including any not mentioned above, promptly notify your doctor for assessment and follow-up.

If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. This is linked to the way your medicine works. For minor cuts and injuries, e.g. cutting yourself shaving, this is of no concern. However, if you are in any doubt at all, you should contact your doctor immediately.

Your ability to drive or operate complicated machinery should not be affected.

Serious side effects, how often they happen & what to do about them

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

How to store it

PLAVIX tablets should be stored in a safe place and be kept out of the reach of children. Do not leave them near a radiator, on a window sill or in a humid place. Do not remove tablets from the packaging until you are ready to take them.

More information

This document plus the full product monograph, prepared for health professionals, can be found at www.sanofi-aventis.ca or by contacting sanofi-aventis Canada Inc. at: 1-800-265-7927.

This leaflet was prepared by sanofi-aventis Canada Inc.

Last revised: May 9, 2011