Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ATORVASTATIN CALCIUM
MYLAN HEALTHCARE SDN. BHD.
ATORVASTATIN CALCIUM
30Tablet Tablets; 100 Tablets
VIATRIS PHARMACEUTICALS LLC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ ZARATOR ® FILM-COATED TABLETS Crystalline Atorvastatin calcium (10 mg, 20 mg, 40 mg or 80 mg) WHAT IS IN THIS LEAFLET 1. What ZARATOR is used for 2. How ZARATOR works 3. Before you use ZARATOR 4. How to use ZARATOR 5. While you are using it 6. Side effects 7. Storage and Disposal of ZARATOR 8. Product Description 9. Manufacturer & Product Registration Holder 10. Date of Revision 11. Serial Number WHAT ZARATOR IS USED FOR ZARATOR belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. ZARATOR is used to lower lipids known as cholesterol [total cholesterol, low- density lipoprotein cholesterol (LDL-C)], apolipoprotein B (apo B) and other fats (triglycerides) and to increase high density lipoprotein cholesterol (HDL-C) in the blood when a low-fat diet and lifestyle changes on their own have failed. ZARATOR can lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as: • Age, smoking, high blood pressure, low HDL-C, heart disease in the family. ZARATOR can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as: • Eye problems, kidney problems, smoking, or high blood pressure. . HOW ZARATOR WORKS ZARATOR works by reducing the amount of cholesterol made by the liver. In terms of good and bad cholesterol, ZARATOR reduces the bad cholesterol and raises the good cholesterol . BEFORE YOU USE ZARATOR _- When you must not use it_ Do not take ZARATOR - if you are hypersensitive (allergic) to ZARATOR or to any of the other ingredients of the medicine; - if you have active liver disease; - if you have had any unexplained abnormal blood tests for liver function; - if you are a woman of child-bearing capacity and not using any type of reliable contraception; - if you are pregnant or trying to become pregnant; - if you are breast-feeding. _- Pregnancy and lactation_ - Do not take ZARATOR if you ar Lire le document complet
1 ZARATOR ® TABLETS CRYSTALLINE ATORVASTATIN CALCIUM 1. TRADE NAME OF THE MEDICINAL PRODUCT ZARATOR 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: crystalline atorvastatin The tablets for oral administration contain crystalline atorvastatin calcium equivalent to 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin. 3. PHARMACEUTICAL FORM Atorvastatin tablets for oral administration contain 10 mg, 20 mg, 40 mg or 80 mg crystalline atorvastatin. 10 mg: White, round, film-coated tablets debossed “10” on one side and “ATV” on the other side. 20 mg: White, round, film-coated tablets debossed “20” on one side and “ATV” on the other side. 40 mg: White, round, film-coated tablets debossed “40” on one side and “ATV” on the other side. 80 mg: White, round, film-coated tablets debossed “80” on one side and “ATV” on the other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Atorvastatin is indicated as an adjunct to diet for the treatment of patients with elevated total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) and to increase high density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia (heterozygous familial and non- familial hypercholesterolemia), combined (mixed) hyperlipidemia ( _Fredrickson_ Types IIa and IIb), elevated serum TG levels ( _Fredrickson_ Type IV), and for patients with dysbetalipoproteinemia ( _Fredrickson_ Type III) who do not respond adequately to diet. Atorvastatin is also indicated for the reduction of total-C and LDL-C in patients with homozygous familial hypercholesterolemia. _Prevention of Cardiovascular Disease_ In adult patients without clinically evident cardiovascular disease (CVD), but with multiple risk factors for coronary heart disease (CHD), such as age, smoking, hypertension, low HDL-C, or a family history of early CHD, ZARATOR is indicated to: - Reduce the risk of _ _ myocardial infarction (MI) - Reduce the risk of stroke 2 - Reduce the Lire le document complet