INILASE

Secondary prevention of atherothrombotic events

Clopidogrel is indicated in:

· adult patients suffering from myocardial infarction (occurring from a few days to less than 35 days), ischaemic stroke (occurring from more than 7 days to less than 6 months) or established peripheral arterial disease;

· adult patients suffering from acute coronary syndrome:

o acute coronary syndrome without ST-segment elevation (unstable angina or non-Q wave myocardial infarction), including patients undergoing coronary angioplasty with stent placement, in association with acetylsalicylic acid (ASA);

o acute myocardial infarction with ST-segment elevation, in association with ASA in patients undergoing percutaneous coronary intervention (including with stent placement) or in patients treated medically and eligible for thrombolytic/fibrinolytic treatment.

In patients presenting with a transient ischaemic attack (TIA) of moderate to high risk, or a minor ischaemic stroke (CVA)

Clopidogrel, in association with ASA, is indicated in:

· adult patients presenting with a TIA of moderate to high risk (ABCD2 score 1 ≥ 4) or a minor ischaemic stroke (NIHSS 2 ≤ 3), within 24 hours following the TIA or ischaemic stroke.

Prevention of atherothrombotic and thromboembolic events in atrial fibrillation

In adult patients suffering from atrial fibrillation, who present at least one risk factor for vascular events, who cannot be treated with an anti-vitamin K (AVK) and who present a low risk of bleeding, clopidogrel is indicated, in association with ASA, in the prevention of atherothrombotic and thromboembolic events, including stroke.

For more information, see section 5.1.

1 Age, blood pressure, clinical features and duration of TIA, diabetes mellitus diagnosis (in English: « Age, Blood pressure, Clinical features, Duration, and Diabetes mellitus diagnosis »).

2 National Institute of Health Stroke Scale (in English: « National Institute of Health Stroke Score »).

Pregnancy

As there is no clinical data on the use of clopidogrel during pregnancy, it is preferable not to use clopidogrel during pregnancy as a precautionary measure.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).

Breastfeeding

In humans, there is no data concerning the excretion of clopidogrel in human milk. Animal studies have shown excretion of clopidogrel in breast milk. As a precautionary measure, breastfeeding should not be continued during treatment with CLOPIDOGREL ZF.

Fertility

Studies in animals have not shown any impairment of fertility with clopidogrel.

clopidogrel has no effect or a negligible effect on the ability to drive vehicles and use machines.