Plavix, clopidogrel

 

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

1.       NAME OF THE MEDICINAL PRODUCT

Plavix 75 mg film‑coated tablets

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film‑coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).

Excipients: each tablet contains 3 mg lactose and 3.3 mg hydrogenated castor oil.

For a full list of excipients, see section 6.1.

3.       PHARMACEUTICAL FORM

Film‑coated tablet.

Pink, round, biconvex, engraved with «75» on one side and «1171» on the other side.

4.       CLINICAL PARTICULARS

4.1     Therapeutic indications

Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:

·                Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

·                Patients suffering from acute coronary syndrome:

-          Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).

-          ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

For further information please refer to section 5.1.

4.2     Posology and method of administration

·        Adults and elderly