Država: Armenija
Jezik: engleski
Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
clopidogrel (clopidogrel besilate)
Acino Pharma AG
B01AC04
clopidogrel (clopidogrel besilate)
75mg
tablets film-coated
(28/2x14/) in blister, (84/6x14/) in blister
Prescription
Registered
2019-04-12
Black Kontur Helvetica Neue LT W1G Roman, Bold, Italic; OCRB Medium 9 pt Tahoma Regular 1 2 Acino Pharma AG – 40915-4018 Clopacin 75 mg fi tab Acino CIS 160 x 420 mm 18.10.2018 EM – 23.10.2018 EM – – – – 29U Patient Information Read all of this leaflet carefully before you start taking/using this medicine. 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. Keep this leaflet. You may need to read it again. Clopacin 75 mg, film-coated tablets What is Clopacin and when is it used? Clopidogrel, the active substance in Clopacin film-coated tablets, belongs to a group of medicines called antiplatelet drugs. Platelets (thrombocytes) are very small blood cells (smaller than red or white blood cells) which clump together during the formation of a blood clot (thrombus). Antiplatelet drugs prevent this clumping and thus reduce the risk of blood clots forming (known as thrombosis). As you have recently suffered a stroke or heart attack or suffer from narrowed peripheral arteries, you are at greater risk of experiencing these events again. To reduce this risk, you have been prescribed Clopacin. Clopacin has also been prescribed to you – for peripheral arterial occlusive disease, or – if you have suffered severe chest pain, known as “unstable angina pectoris”, or have suffered a “heart attack”. If so, your doctor may prescribe you acetylsalicylic acid (a substance present in many medicines for pain and fever) at the same time or – if you have an irregular heart rate known as atrial fibrillation and you cannot be treated with oral anticoagulants. In this case, the doctor will also prescribe you acetylsalicylic acid. Clopacin is likewise used in combination with acetylsalicylic acid to prevent thrombosis after a vascular prosthesis (stent) has been implanted. Clopacin may be taken only when prescribed by a doctor and must not be passed on to other people. What should be taken into consideration? Certain factors such as Pročitajte cijeli dokument
CLOPACIN 75, FILM-COATED TABLETS MANUSCRIPT OF THE PRESCRIBING INFORMATION ACINO PHARMA AG_ _ _ _ 1/13 CLOPACIN 75, FILM-COATED TABLETS COMPOSITION Active substance: Clopidogrel as clopidogrel besilate. Excipients: Macrogol 6000, carbon dioxide, microcrystalline cellulose (E 460), crospovidone, hydrogenated castor oil, ethyl cellulose, titanium dioxide. PHARMACEUTICAL FORM AND AMOUNT OF ACTIVE SUBSTANCE PER UNIT One film-coated tablet contains 111.85 mg clopidogrel besilate (equivalent to 75 mg clopidogrel). INDICATIONS/POSSIBILITIES FOR USE Clopidogrel is indicated in the following cases for the secondary prevention of atherothrombotic events in adults: − Prevention of atherothrombotic events such as myocardial infarction, stroke, vascular death in patients with recent stroke (from 7 days to approximately 6 months previously), recent myocardial infarction (from a few days to 5 weeks previously) or manifest peripheral arterial occlusive disease. − In combination with acetylsalicylic acid (ASA) in patients with acute coronary syndrome without ST segment elevation (unstable angina pectoris or non-Q-wave infarction). − In combination with ASA after fibrinolysis in acute myocardial infarction with ST segment elevation. − Clopidogrel is used in combination with ASA for the prevention of thrombotic events after coronary stent placement. Clopidogrel is also indicated in combination with ASA in adult patients with atrial fibrillation who have a stroke risk factor with a CHAD2DS2-VASc score ≥1 and who decline oral anticoagulants or do not tolerate anticoagulants for a reason other than haemorrhaging. POSOLOGY/ADMINISTRATION Clopacin is taken once daily, with food or between meals. _Prevention of atherothrombotic events _ Once daily 1 film-coated tablet (equivalent to 75 mg Clopacin). _Acute coronary syndrome and stent _ _Acute coronary syndrome without ST segment elevation_: Clopacin treatment is started with an initial dose of 300 mg (four 75 mg tablets) and then continued with one 75 mg tablet once a day for l Pročitajte cijeli dokument