PLAVIX 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Plavix 300 mg Film-Coated Tablets

clopidogrel

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Plavix and what is it used for
2. What you need to know before you take Plavix
3. How to take Plavix
4. Possible side effects
5. Storage of Plavix
6. Contents of the pack and other information

1. What is Plavix and what is it used for

Plavix contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that help it to clot. Antiplatelet agents prevent platelet clumping, reducing the risk of blood clots (a process called thrombosis).

Plavix is given to adults to prevent blood clots (thrombi) in blood vessels (arteries) that have become hardened, a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, myocardial infarction, or death).

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

• you have a condition that leads to hardening of the arteries (also known as atherosclerosis), and
• you have previously had a heart attack, stroke, or suffer from a disease known as peripheral arterial disease, or
• you have had a severe type of chest pain known as "unstable angina" or "myocardial infarction". For the treatment of this disease, your doctor may need to place a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and reduce fever, as well as to prevent blood clots).
• you have experienced symptoms of a stroke that disappear within a short period (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer acetylsalicylic acid to you within the first 24 hours.
• you have an irregular heartbeat, a condition called "atrial fibrillation", and cannot take medications known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new clots and prevent the growth of existing clots. You will have been told that "oral anticoagulants" are more effective than acetylsalicylic acid or the combined use of Plavix and acetylsalicylic acid for this disease. Your doctor will have prescribed Plavix plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a risk of severe bleeding.

2. What you need to know before you take Plavix

Do not take Plavix

• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• If you have an active bleeding condition, such as a stomach ulcer or bleeding in the brain.
• If you have a severe liver disease.

If you think any of these apply to you, or if you are unsure, consult your doctor before taking Plavix.

Warnings and precautions

Before starting treatment with Plavix, inform your doctor if you are in any of the following situations:

• If you are at risk of bleeding (bleeding) because:

• you have a disease that involves a risk of internal bleeding (such as a stomach ulcer).
• you have a blood disorder that predisposes you to internal bleeding (bleeding in tissues, organs, or joints of the body).
• you have recently had a severe injury.
• you have recently undergone surgery (including dental surgery).
• you are scheduled to undergo surgery (including dental surgery) within the next seven days.
• • If you have had a blood clot in an artery of the brain (ischemic stroke) in the last 7 days.
  • If you have liver or kidney disease.
  • If you have had an allergy or reaction to any medication used to treat your disease.
  • If you have had a non-traumatic cerebral hemorrhage.

During treatment with Plavix:

• Tell your doctor if you are scheduled to have surgery (including dental surgery).
• Tell your doctor immediately if you develop a disorder (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bruises) under the skin that may appear as red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• If you cut or injure yourself, bleeding may take longer than usual to stop. This is related to the way the medicine works, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cuts while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and precautions").
• Your doctor may ask you to have blood tests.

Children and adolescents

This medicine should not be given to children as it is not effective.

Taking Plavix with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect the use of Plavix or vice versa.

You must specifically tell your doctor if you are taking:

• medicines that may increase the risk of bleeding, such as:

• oral anticoagulants, medicines used to decrease blood clotting,

• non-steroidal anti-inflammatory drugs, medicines used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medicine used to decrease blood clotting,
• ticlopidine, or other antiplatelet agents,
• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other medications of the same type), medicines used to treat depression,
• rifampicin (used for severe infections)

• omeprazole or esomeprazole, medicines to treat stomach upset,
• fluconazole or voriconazole, medicines to treat bacterial and fungal infections,
• efavirenz, or other antiretroviral medications (used to treat HIV infections),
• carbamazepine, a medicine to treat some forms of epilepsy,
• moclobemide, a medicine for depression,
• repaglinide, a medicine for diabetes,
• paclitaxel, a medicine for cancer,
• opioids: if you are being treated with clopidogrel, you should tell your doctor before any opioid is prescribed to you (used to treat severe pain),
• rosuvastatin (used to lower cholesterol levels).

If you have had severe chest pain (unstable angina or myocardial infarction), a transient ischemic attack, or a mild ischemic stroke, you may have been prescribed Plavix in combination with acetylsalicylic acid, a substance found in many medications used to relieve pain and reduce fever. An occasional dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) is not likely to cause any problems, but prolonged use in other circumstances should be discussed with your doctor.

Taking Plavix with food and drinks

Plavix can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or think you may be pregnant, you should tell your doctor or pharmacist before taking Plavix. If you become pregnant while taking Plavix, you should consult your doctor immediately, as it is not recommended to take clopidogrel during pregnancy.

You should not breastfeed while taking this medicine.

If you are breastfeeding or plan to breastfeed, you should inform your doctor before taking this medicine.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

It is unlikely that Plavix will affect your ability to drive or use machines.

Plavix contains lactose

If your doctor has told you that you have an intolerance to some sugars (e.g., lactose), you should consult him before taking this medicine.

Plavix also contains hydrogenated castor oil

This may cause stomach upset and diarrhea.

3. How to take Plavix

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose, even for patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg Plavix tablet per day, taken orally with or without food and at the same time each day.

If you have had severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe you 300 mg or 600 mg of Plavix (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) to be taken once at the start of treatment. After that, the recommended dose is one 75 mg Plavix tablet per day, as described above.

If you have experienced symptoms of a stroke that disappear within a short period (also known as a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe you 300 mg of Plavix (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. After that, the recommended dose is one 75 mg Plavix tablet per day, as described above, with acetylsalicylic acid for 3 weeks. After that, your doctor will prescribe either Plavix alone or acetylsalicylic acid alone.

You should take Plavix for as long as your doctor continues to prescribe it.

If you take more Plavix than you should

Contact your doctor or go to the nearest hospital emergency department, as there is a higher risk of bleeding.

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

4. Possible side effects

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

Contact your doctor immediately if you experience:

• Fever, signs of infection, or extreme fatigue. These may be due to a rare decrease in some blood cells.
• Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), associated or not with bleeding that appears under the skin as red spots and/or confusion (see section 2 "Warnings and precautions").
• Swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin. These may be signs of an allergic reaction.

The most common side effect reported with Plavix is bleeding. Bleeding may occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases of bleeding from the blood vessels of the eyes, intracranial, pulmonary, or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Plavix

If you cut or injure yourself, bleeding may take a little longer than usual to stop. This is related to the mechanism of action of the medicine, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cuts while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and precautions").

Other side effects include:

Common side effects (may affect up to 1 in 10 people):

Diarrhea, abdominal pain, indigestion, or heartburn.

Uncommon side effects (may affect up to 1 in 100 people):

Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in stomach or intestine, rash, itching, dizziness, tingling, and numbness.

Rare side effects (may affect up to 1 in 1,000 people):

Dizziness, breast enlargement in men.

Very rare side effects (may affect up to 1 in 10,000 people):

Jaundice; severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions (e.g., general feeling of heat with sudden general discomfort leading to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mouth mucosa (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

Side effects with unknown frequency (cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

Additionally, your doctor may observe changes in the results of your blood or urine tests.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Plavix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister, after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration.

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

6. Package Contents and Additional Information

Composition of Plavix

The active ingredient is clopidogrel. Each tablet contains 300 mg of clopidogrel (as hydrogen sulfate).

The other components are (see section 2 "Plavix contains lactose" and "Plavix contains hydrogenated castor oil"):

• Core of the tablet: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000, and low-substituted hydroxypropylcellulose.
• Coating of the tablet: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172), and titanium dioxide (E171).
• Varnish: carnauba wax.

Appearance of the Product and Package Contents

Plavix 300 mg film-coated tablets are oblong, pink, and engraved with the number "300" on one side and the number "1332" on the other. Plavix is available in cardboard boxes of 4x1, 10x1, 30x1, and 100x1 tablets in aluminum/aluminum unit-dose blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer:

Sanofi Winthrop Industrie

1, Rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France.

For more information about this medicinal product, please contact the local representative of the marketing authorization holder.

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/