Maa: Armenia
Kieli: englanti
Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
clopidogrel (clopidogrel bisulfate)
ONE PHARMA INDUSTRIAL PHARMACEUTICAL COMPANY SOCIETE ANONYME
B01AC04
clopidogrel (clopidogrel bisulfate)
75mg
tablets film-coated
(28/4x7/) in blister
Prescription
Registered
2022-03-09
IN THIS LEAFLET 1. What CLOPIDOGREL-ASTERIA is and what it is used for 2. What you need to know before you take CLOPIDOGREL-ASTERIA 3. How to take CLOPIDOGREL-ASTERIA 4. Possible side effects 5. How to store CLOPIDOGREL-ASTERIA 6. Contents of the pack and other information 1. WHAT CLOPIDOGREL-ASTERIA IS AND WHAT IT IS USED FOR CLOPIDOGREL-ASTERIA contains clopidogrel and 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-ASTERIA is taken by adults to prevent blood clots 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-ASTERIA 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 of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor. · You have an irregular heartbeat, a condition called ‘atrial fibrillation’, and you cannot take medicines known as ‘oral anticoagulants’ (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing. You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid or the combined use Lue koko asiakirja
Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CLOPIDOGREL-ASTERIA 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CLOPIDOGREL-ASTERIA 75 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate). Excipients with known effect: Each film-coated tablet contains 4.16 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. CLOPIDOGREL-ASTERIA 75 mg film-coated tablets Pink, round, biconvex tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Secondary prevention of atherothrombotic events _ Clopidogrel is indicated 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. _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. Page 2 of 20 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS AND ELDERLY CLOPIDOGREL-ASTERIA 75 mg film-coated tablets Clopidogrel should be given as a single daily dose of 75 mg. In patients suffering from acute coronary Lue koko asiakirja