Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOPIDOGREL BISULPHATE
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
CLOPIDOGREL BISULPHATE
30 Tablets; 14 Tablets; 28 Tablets
Sandoz Private Limited
KOGREL ® FILM COATED TABLETS Clopidogrel bisulphate (75mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ WHAT IS IN THIS LEAFLET 1. What _Kogrel_ is used for 2. How _ Kogre_ l works _3._ _ _ Before you take _ Kogrel _ 4. How to take _Kogrel_ 5. While you are using _Kogrel_ 6. Side effects 7. Storage and Disposal of _Kogrel _ 8. Product Description 9. Manufacturer and Product 10. Registration Holder 11. Date of Revision WHAT _KOGREL_ IS USED FOR You have been prescribed _Kogrel_ 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. HOW _KOGREL_ WORKS _Kogrel_ belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood, smaller than red or white blood cells, which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis). _Kogrel_ is taken 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). BEFORE YOU TAKE _KOGREL_ - _When you must not use it _ • If you are allergic (hypersensitive) to _Kogrel_ or any of the other ingredients of _Kogrel_ • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain • If you suffer from severe liver disease - _Before you start to use it _ Tell your doctor or pharmacist before starting to take _KOGREL_ if you ha Baca dokumen lengkap
KOGREL ® 1. NAME OF THE MEDICINAL PRODUCT Kogrel 75 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg clopidogrel. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Kogrel 75 mg film-coated tablets are pink colored, round shaped, engraved with 'SZ' 75 on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clopidogrel is indicated for the prevention of atherothrombotic events 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. For further information, please refer to section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg with or without food. In patients suffering from acute coronary syndrome: • Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction: Clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg - 325 mg daily). Since higher doses of ASA were associated with higher bleeding risk, it is recommended that the dose of ASA should not be higher than 100 mg. The optimal duration of treatment has not been formally established. Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months. • ST segment elevation acute myocardial infarction: Baca dokumen lengkap