Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
clopidogrel
Archie Samiel s.r.o.
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.
Revision: 12
Withdrawn
2009-07-28
B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE USER CLOPIDOGREL RATIOPHARM GMBH 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 your 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Clopidogrel ratiopharm GmbH is and what it is used for 2. What you need to know before you take Clopidogrel ratiopharm GmbH 3. How to take Clopidogrel ratiopharm GmbH 4. Possible side effects 5. How to store Clopidogrel ratiopharm GmbH 6. Contents of the pack and other information 1. WHAT CLOPIDOGREL RATIOPHARM GMBH IS AND WHAT IT IS USED FOR Clopidogrel ratiopharm GmbH contains the active ingredient Clopidogrel which 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 ratiopharm GmbH 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 ratiopharm GmbH 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 Прочитайте повний документ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Clopidogrel ratiopharm GmbH 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 secondary prevention of atherothrombotic events in: • Adult 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. • Adult 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 Posology • Adults and elderly 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 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 sup Прочитайте повний документ