Country: European Union
Language: English
Source: EMA (European Medicines Agency)
clopidogrel (as hydrochloride)
Krka, d.d., Novo mesto
B01AC03
clopidogrel
Antithrombotic agents
Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Secondary prevention of atherothrombotic eventsClopidogrel is indicated in:Adult patients suffering from myocardial infarction (from a few days until less than 35days), ischaemic stroke (from 7days until less than 6months) 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 fibrillationIn 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.
Revision: 14
Authorised
2009-09-20
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE USER CLOPIDOGREL KRKA D.D. 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 Krka d.d. is and what it is used for 2. What you need to know before you take Clopidogrel Krka d.d. 3. How to take Clopidogrel Krka d.d. 4. Possible side effects 5. How to store Clopidogrel Krka d.d. 6. Contents of the pack and other information 1. WHAT CLOPIDOGREL KRKA D.D. IS AND WHAT IT IS USED FOR Clopidogrel Krka d.d. 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 Krka d.d. 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 Krka d.d. 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 infarcti Read the complete document
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Clopidogrel Krka d.d. 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride). For the 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 _Secondary prevention of atherothrombotic events_ Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic 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 patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. _In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)_ _Clopidogrel in combination with ASA is indicated in:_ ˗ Adult patients with moderate to high-risk TIA (ABCD2 1 score ≥4) or minor IS (NIHSS 2 ≤3) within 24 hours of either the TIA or IS event. _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 Read the complete document