Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROSUVASTATIN CALCIUM
PHARMANIAGA MANUFACTURING BERHAD
ROSUVASTATIN CALCIUM
30 Tablets
PHARMANIAGA MANUFACTURING BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ROXATIN TABLET Rosuvastatin Calcium (10mg / 20mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What Roxatin Tablet is used for 2. How Roxatin Tablet works 3. Before you use Roxatin Tablet 4. How to use Roxatin Tablet 5. While you are using Roxatin Tablet 6. Side effects 7. Storage and disposal of Roxatin Tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ROXATIN TABLET IS USED FOR You have been prescribed Roxatin because: a) You have a high cholesterol level. This means you are at risk of getting a heart attack or stroke. You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol- lowering diet and exercise while you are taking Roxatin. Or b) You have other factors that increase your risk of getting a heart attack, stroke or related health problems. Heart attack, stroke and other problems can be caused by a disease called atherosclerosis. Atherosclerosis is due to build- up of fatty deposits in your arteries. HOW ROXATIN TABLET WORKS Roxatin is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol. There are different types of cholesterol found in the blood, including ‘bad’ cholesterol (LDL- C) and ‘good’ cholesterol (HDL- C). • Roxatin can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol. • It works by helping to block your body’s production of ‘bad’ cholesterol in the liver. It also improves your body’s ability to remove it from your blood. For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow. Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a he Baca dokumen lengkap
ROXATIN TABLET 10 MG ROXATIN TABLET 20 MG COMPOSITION Roxatin Tablet 10 mg Each film coated tablet contains 10mg Rosuvastatin (as calcium salt) Roxatin Tablet 20mg Each film coated tablet contains 20mg Rosuvastatin (as calcium salt) DESCRIPTION Roxatin Tablet 10 mg Round (7 mm), light brick red biconvex film-coated tablet with Pharmaniaga icon on one side and plain on the other. Roxatin Tablet 20mg Round (9.5 mm), light brick red, biconvex film-coated tablet with Pharmaniaga icon on one side and plain on the other. PHARMACODYNAMICS Rosuvastatin is a selective, potent and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. Triglycerides (TG) and cholesterol in the liver are incorporated, with apolipoprotein B (ApoB), into very low density lipoprotein (VLDL) and released into the plasma for delivery to peripheral tissues. VLDL particles are TG-rich. Cholesterol-rich low density lipoprotein (LDL) is formed from VLDL and is cleared primarily through the high affinity LDL receptor in the liver. Rosuvastatin produces its lipid-modifying effect in two ways; it increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles. High density lipoprotein (HDL), which contains ApoA-I is involved, amongst other things, in transport of cholesterol from tissues back to the liver (reverse cholesterol transport). The involvement of LDL-C in atherogenesis has been well documented. High LDL-C, TG, low HDL-C and ApoA-I have been linked to a higher risk of cardiovascular disease. Available data have shown the benefits on mortality and CV event rates of lowering LDL-C and TG or raising HDL-C. More recent data has linked the beneficial effects of HMG-CoA reductase inhibitors to lowering of non-HDL (i.e. all circulating cholesterol not in HDL) and ApoB or reducing the ApoB/ApoA-I ra Baca dokumen lengkap