Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROSUVASTATIN CALCIUM
SPG PHARMA (MALAYSIA) SDN BHD
ROSUVASTATIN CALCIUM
3 x 10's Tablets
SIAM BHEASACH CO LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 SUROTIN FC TABLET Rosuvastatin (10mg / 20mg) WHAT IS IN THIS LEAFLET 1. What SUROTIN Tablet is used for 2. How SUROTIN Tablet works 3. Before you use SUROTIN Tablet 4. How to use SUROTIN Tablet 5. While you are using SUROTIN Tablet 6. Side effects 7. Storage and disposal of SUROTIN Tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision 1. WHAT SUROTIN TABLET IS USED FOR You have been prescribed SUROTIN 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 SUROTIN. 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. 2. HOW SUROTIN TABLET WORKS SUROTIN 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). • SUROTIN 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 heart Baca dokumen lengkap
Sent date 25/04/2023 Drawing No. SUR-10-20-02-L-ENG-MY-BN-A0001 PRODUCT NAME SUROTIN 10 MG FC TABLET SUROTIN 20 MG FC TABLET NAME AND STRENGTH OF ACTIVE SUBSTANCE 10 mg: Each tablet contains 10 mg rosuvastatin (as rosuvastatin calcium) 20 mg: Each tablet contains 20 mg rosuvastatin (as rosuvastatin calcium) PRODUCT DESCRIPTION 10 mg: A pink round (diameter: 7 mm), biconvex film-coated tablet engraved with “ ” logo on one side and a score with “R” and “10” on the other side 20 mg: A pink round (diameter: 9 mm), biconvex film-coated tablet engraved with “ ” logo on one side and on the other side having a score with “R” on the top and “20” on the bottom The tablet is not meant to be split PHARMACODYNAMICS Pharmacotherapeutic group: HMG-CoA reductase inhibitors Mechanism of action Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate (a precursor for 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 effects 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. Epidemiological studies have established that high LDL-C, TG, low HDL-C and ApoA-I have been linked to a higher risk of cardiovascular Baca dokumen lengkap