Country: European Union
Language: English
Source: EMA (European Medicines Agency)
clopidogrel
Acino AG
B01AC04
clopidogrel
Antithrombotic agents
Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
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, 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, Patients suffering from acute coronary syndrome., ,
Revision: 6
Withdrawn
2009-07-28
26 B. PACKAGE LEAFLET Medicinal product no longer authorised 27 PACKAGE LEAFLET: INFORMATION FOR THE USER CLOPIDOGREL ACINO 75 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 have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4. WHAT IS IN THIS LEAFLET : 1. What Clopidogrel Acino is and what it is used for 2. What you need to know before you take Clopidogrel Acino 3. How to take Clopidogrel Acino 4. Possible side effects 5. How to store Clopidogrel Acino 6. Contents of the pack and other information 1. WHAT CLOPIDOGREL ACINO IS AND WHAT IT IS USED FOR Clopidogrel Acino contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products. Platelets (so-called thrombocytes) are very small structures, which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis). Clopidogrel Acino is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death). You have been prescribed Clopidogrel Acino to help prevent blood clots and reduce the risk of these severe 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 (disturbed blood flow in arms or legs caused by vascular occlusions) or - You have experienced a severe type of Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Clopidogrel Acino 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as besilate). Excipients with known effect Each film-coated tablet contains 3.80 mg of hydrogenated castor oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white, marbled, round and biconvex film-coated tablets. 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. _Prevention of atherothrombotic and thromboembolic events in atrial fibrillation _ In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and older people Clopidogrel should be given as a single daily dose of 75 mg. In patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave m Read the complete document