Plavix ® 75 mg Film-Coated Tablets

You have been prescribed PLAVIX to help prevent blood clots and reduce the risk of these events because:

• You have a condition of hardening of arteries (also known as atherosclerosis), and
• You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or
• You have experienced a severe type of chest pain known as “unstable angina” or “myocardial infarction” (heart attack).

In this case you should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.

Do not take PLAVIX:

• if you are hypersensitive (allergic) to the active ingredient clopidogrel or to any of the other ingredients of PLAVIX.
• if you are hypersensitive (allergic) to other anti-platelet medicines called thienopyridine (such as ticlopidine, prasugrel), used to prevent blood clots.
• if you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
• if you suffer from severe liver disease.
• if you are pregnant or breastfeeding.
• If you suffer from a dysfunction of, or reduction in, blood platelets which increases risk of bleeding and bruising.

If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking PLAVIX.

Always take PLAVIX exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Do not share PLAVIX prescribed for you with others. The usual dose is one 75 mg tablet of PLAVIX 75 mg per day to be taken orally with a glass of water, with or without food. You should take your medicine regularly and at the same time each day.

Duration of treatment: You should take PLAVIX for as long as your doctor continues to prescribe it.

If you take more PLAVIX than you should: In the event of overdosage, immediately consult your doctor or pharmacist because of the increased risk of bleeding. If neither is available, rush the patient to the nearest hospital or poison control centre.

If you forget to take PLAVIX: If you forget to take a dose of PLAVIX, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual 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 forgotten individual dose.

If you stop taking PLAVIX: Do not stop the treatment unless your doctor tells you so. Contact your doctor of pharmacist before stopping. If you have been told by your doctor to stop treatment temporarily, ask your doctor when to restart the treatment. If you have any further questions on the use of PLAVIX, ask your doctor or pharmacist.

PLAVIX can have side effects. Contact your doctor immediately if you experience:

• fever, signs of infection or extreme tiredness. These may be due to a 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 which appears under the skin as red pinpoint dots, and/or confusion (see Take special care with PLAVIX).
• swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be the signs of an allergic reaction.

The most frequent side effect which has been seen with PLAVIX is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.

If you experience prolonged bleeding when taking PLAVIX: If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. This is linked to the way PLAVIX works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g. cutting yourself shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see Take special care with PLAVIX).

Other side effects which have been seen with PLAVIX are:

• Frequent side effects: Diarrhoea, abdominal pain, indigestion or heartburn.
• Less frequent side effects: Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness; vertigo; enlarged breasts in males, jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste, inflammation of small vessels.
• Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain.

Your doctor may identify changes in your blood or urine tests. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, contact your doctor or pharmacist. Not all side effects reported for PLAVIX are included in this leaflet. Should your general health worsen while taking PLAVIX, please consult your doctor, pharmacist or other healthcare professional for advice.

KEEP OUT OF REACH AND SIGHT OF CHILDREN. Store below 25 °C and protect from light. Do not remove blisters from the carton until required. Do not use PLAVIX after the expiry date stated on the carton and on the blister. Do not use PLAVIX if you notice any visible sign of deterioration. Return all unused tablets to your pharmacist for safe disposal.