Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
clopidogrel (as hydrochloride)
Mylan dura 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.
Revision: 6
Withdrawn
2009-07-21
B. PACKAGE LEAFLET 22 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER CLOPIDOGREL DURA 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 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 have any side effects, including any side effects not listed in this leaflet, please talk to your doctor or pharmacist. See section 4. WHAT IS IN THIS LEAFLET 1. What Clopidogrel dura is and what it is used for 2. What you need to know before you take Clopidogrel dura 3. How to take Clopidogrel dura 4. Possible side effects 5. How to store Clopidogrel dura 6. Contents of the pack and other information 1. WHAT CLOPIDOGREL DURA IS AND WHAT IT IS USED FOR Clopidogrel dura 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 dura 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 dura 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOPIDOGREL DURA DO NOT TAKE CLOPIDOGREL DURA • if you are allergic to clopidogrel or Lugege kogu dokumenti
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Clopidogrel dura 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride). Excipient with known effect: Each film-coated tablet contains 13 mg hydrogenated castor oil. 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 _Prevention of atherothrombotic events _ Clopidogrel is indicated in: • Adults 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 Posology • Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg. If a dose is missed: - Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time. - For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose. • Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1). • Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4). • Hepatic impairment 2 Medicinal product no longer authorised Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4). Method of administration For oral use It may be given with or without food. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Severe hepatic impairment. • Active pathological bleeding such as peptic ulcer or intracranial haemorr Lugege kogu dokumenti