Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLOPIDOGREL BESILATE
McDowell Pharmaceuticals
75 Base Milligrams
Film Coated Tablet
2011-09-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clopidogrel 75 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 111.86 mg clopidogrel besilate corresponding to 75 mg clopidogrel. Excipients: Each film-coated tablet contains 73.61 mg lactose anhydrous and 0.29 mg lecithin (contains soya oil) (E322). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-Coated Tablet _Product imported from the UK:_ Pink 9 mm round, biconvex, film-coated tablet, engraved with “II” on one face. 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_ Clopidogrel should be given as a single daily dose of 75 mg with or without food. In patients suffering from acute coronary syndrome: Non -ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300-mg loading dose and then continued at 75 mg once a day (with acetylsalicylic Read the complete document