Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
clopidogrel (as hydrochloride)
Teva Pharma B.V.
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.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.
Revision: 3
Withdrawn
2010-10-28
23 B. PACKAGE LEAFLET Medicinal product no longer authorised 24 PACKAGE LEAFLET: INFORMATION FOR THE USER CLOPIDOGREL TEVA GENERICS B.V. 75 MG FILM-COATED TABLETS Clopidogrel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Clopidogrel Teva Generics B.V. is and what it is used for 2. Before you take Clopidogrel Teva Generics B.V. 3. How to take Clopidogrel Teva Generics B.V. 4. Possible side effects 5. How to store Clopidogrel Teva Generics B.V. 6. Further information 1. WHAT CLOPIDOGREL TEVA GENERICS B.V. IS AND WHAT IT IS USED FOR Clopidogrel Teva Generics B.V. belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood, 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 Teva Generics B.V. is taken 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 Teva Generics B.V. 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, or - You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial infarction’ (heart attack). For the treatment Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Generics B.V. 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride). Excipient: Each film-coated tablet contains 13 mg hydrogenated castor oil. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink, round and slightly convex 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. 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 acid (ASA) 75 mg-325 mg daily). Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg. The optimal duration of treatment has not been formally established. Clinical trial data supp Aqra d-dokument sħiħ