Valsts: Nīderlande
Valoda: holandiešu
Klimata pārmaiņas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CLOPIDOGRELWATERSTOFSULFAAT SAMENSTELLING overeenkomend met ; CLOPIDOGREL
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
B01AC04
CLOPIDOGRELWATERSTOFSULFAAT COMPOSITION corresponding to ; CLOPIDOGREL
Filmomhulde tablet
CASTOROLIE, GEHYDREERD ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MANNITOL (D-) (E 421) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Clopidogrel
Hulpstoffen: CASTOROLIE, GEHYDREERD; CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); GLYCEROLTRIACETAAT (E 1518); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 6000; MANNITOL (D-) (E 421); TITAANDIOXIDE (E 171);
2016-12-21
PACKAGE LEAFLET: INFORMATION FOR THE USER CLOPIDOGREL STADA 75 MG, FILMOMHULDE TABLETTEN 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 [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] 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). [Product name] 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 [Product name] 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 hav Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Clopidogrel STADA 75 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate). Excipients with known effect Each film-coated tablet contains 5.2 mg castor oil, hydrogenated and 2.8 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet [Product name] are pink coloured, round, biconvex, bevelled edged film-coated tablets with 9 mm diameter. 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. _In patients with moderate to high-risk Transient Ischaemic Attack (TIA) or minor Ischaemic _ _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 1 Age, Blood pressure, Clinical features, Duration, and Diabetes mellitus diagnosis 2 National Institutes of Health Stroke Sca Izlasiet visu dokumentu