Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
clopidogrel
Acino Pharma GmbH
B01AC04
clopidogrel
Antithrombotic agents
Peripheral Vascular Diseases; Stroke; Myocardial Infarction
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.For further information please refer to section 5.1.
Revision: 2
Withdrawn
2009-09-21
B. PACKAGE LEAFLET 20 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER CLOPIDOGREL SANDOZ 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 Sandoz is and what it is used for 2. Before you take Clopidogrel Sandoz 3. How to take Clopidogrel Sandoz 4. Possible side effects 5. How to store Clopidogrel Sandoz 6. Further information 1. WHAT CLOPIDOGREL SANDOZ IS AND WHAT IT IS USED FOR Clopidogrel Sandoz 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 Sandoz 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 Sandoz 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) 2. BEFORE YOU TAKE CLOPIDOGREL SANDOZ DO NOT TAKE CLOPIDOGREL SANDOZ: If you are allergic (hypersensitive) to clopidogrel or an Lestu allt skjalið
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Clopidogrel Sandoz 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as besilate). Excipients: each tablet contains 3.80 mg hydrogenated castor oil. For a 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. 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. Pharmacogenetics CYP2C19 poor metaboliser status is associated with diminished response to clopidogrel. The optimal dose regimen for poor metabolisers has yet to be determined (see section 5.2). Paediatric patients The safety and efficacy of clopidogrel in children and adolescents have not yet been established. Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4). Hepatic impairment Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4). 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Severe liver impairment. Active pathological bleeding such as peptic ulcer or intracranial haemorrhage. 2 Medicinal product no longer authorised 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _Bleeding and haematological disorders _ Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or Lestu allt skjalið