Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SIMVASTATIN
ORGANON MALAYSIA SDN. BHD.
SIMVASTATIN
15 Tablet Tablets; 120Tablet Tablets; 30Tablet Tablets
Organon Pharma (UK) Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ZOCOR ® _ _ _ Simvastatin (10mg, 20mg, 40mg) _ _ _ 1 Copyright 2023 Organon group of companies. All rights reserved. WHAT IS IN THIS LEAFLET 1. What _ZOCOR _ is used for 2. How _ZOCOR _ works _3._ _ _ Before you take _ZOCOR _ 4. How to take _ZOCOR_ 5. While you are using _ZOCOR_ 6. Side effects _7._ _ _ Storage and Disposal of _ZOCOR _ 8. Product Description 9. Manufacturer and product registration holder 10. Date of revision WHAT _ZOCOR _IS USED FOR Your doctor has prescribed _ZOCOR _ to reduce the health risks associated with coronary heart disease (CHD). If you have CHD, diabetes, history of stroke, or other vessel disease (regardless of the amount of cholesterol in your blood), _ZOCOR_ : • can prolong your life by reducing the risk of heart attack or stroke • reduces the need for surgery to increase blood flow to the legs and major organs such as the heart • reduces the need for hospitalization for chest pain (called angina). _ZOCOR _ reduces the amount of cholesterol in your blood. Cholesterol can cause CHD by clogging the blood vessels that carry oxygen and nutrients to the heart. This clogging, or hardening of the arteries, is called atherosclerosis. Atherosclerosis can lead to chest pain (called angina) and heart attack. _ZOCOR _ also slows the progression of atherosclerosis and reduces the development of new atherosclerosis. HOW _ZOCOR _WORKS _ZOCOR _ reduces the level of LDL (bad) cholesterol and fatty substances called triglycerides in your blood and raises HDL (good) cholesterol. It is a member of the class of drugs called hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors. BEFORE YOU TAKE _ZOCOR _ _ _ _-_ _ _ _When you must not take it _ Do not take _ZOCOR _ if you are: • allergic to any of its components • diagnosed with active liver disease • pregnant or breast-feeding • taking any of the following medicines: – certain antifungal medicines (such as itraconazole, ketoconazole, posaconazole, or voriconazole) LDL-choleste Read the complete document
1 LPC-OG0733-T-052023 LOCAL PRODUCT CIRCULAR Tablets ZOCOR ® (simvastatin) ZOCOR (simvastatin) is a lipid-lowering agent derived synthetically from a fermentation product of _Aspergillus terreus_. After oral ingestion, ZOCOR, an inactive lactone, is hydrolyzed to the corresponding β- hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3- methylglutaryl- coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes an early and rate-limiting step in the biosynthesis of cholesterol. Clinical studies show ZOCOR to be highly effective in reducing total plasma cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and very-low-density lipoprotein cholesterol (VLDL-C) concentrations, and increasing high- density lipoprotein cholesterol (HDL-C) in heterozygous familial and non-familial forms of hypercholesterolemia, and in mixed hyperlipidemia when elevated cholesterol was cause for concern and diet alone has been insufficient. Marked responses are seen within 2 weeks, and maximum therapeutic responses occur within 4-6 weeks. The response is maintained during continuation of therapy. When therapy with ZOCOR is stopped, cholesterol and lipids return to pretreatment levels. The active form of simvastatin is a specific inhibitor of HMG-CoA reductase, the enzyme which catalyzes the conversion of HMG-CoA to mevalonate. Because the conversion of HMG-CoA to mevalonate is an early step in the biosynthetic pathway of cholesterol, therapy with ZOCOR would not be expected to cause an accumulation of potentially toxic sterols. In addition, HMG-CoA is also metabolized readily back to acetyl-CoA, which participates in many biosynthetic processes in the body. In animal studies, after oral dosing, simvastatin had high selectivity for the liver, where it achieved substantially higher concentrations than in non-target tissues. Simvastatin undergoes extensive first-pass extraction in the liver, the primary site of action, with subsequent excretion of drug in the bile. Systemic expo Read the complete document