Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SIMVASTATIN
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
SIMVASTATIN
3x10 Tablets; 10 x 10 Tablets
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ VASCOR TABLET 4 0MG FILM COATED Simvastatin (40mg) 1 WHAT IS IN THIS LEAFLET 1. What VASCOR TABLET is used for 2. How VASCOR TABLET works 3. Before you use VASCOR TABLET 4. How to use VASCOR TABLET 5. While you are using VASCOR TABLET 6. Side effects 7. Storage and disposal of VASCOR TABLET 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT VASCOR TABLET IS USED FOR VASCOR TABLET helps to lower cholesterol. VASCOR TABLET is used in people who have coronary heart disease (CHD) [plaque builds up in the coronary arteries] or who are at high risk of CHD (for example, if they have diabetes, a history of stroke, or other blood vessel disease). VASCOR TABLET may be used in these people, regardless of their cholesterol level to: help prolong life by reducing the risk of a heart attack the reduce risk of stroke reduce the need for surgery to increase blood flow to the heart HOW VASCOR TABLET WORKS VASCOR TABLET belongs to a group of medicines known as HMG-CoA reductase inhibitors. It works by reducing the amount of cholesterol made by the liver. VASCOR TABLET reduces the bad cholesterol (LDL-C) and raises the good cholesterol (HDL-C). BEFORE YOU USE VASCOR TABLET _-_ _When you must not use it_ Do not use VASCOR TABLET if you are allergic to simvastatin or any of the other ingredients listed at the end of the leaflet. Symptoms of an allergic reaction may include skin rash, itchiness, short of breath, swelling of the tongue or face, or painful joints. Do not used VASCOR TABLET if you have had muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides _-_ _Before you start to use it_ Before taking VASCOR TABLET, you must tell your doctor or pharmacist if you have, or have had, any of the following conditions: Active liver disease Kidney disease Drink alcohol regularly Allergic to any other medicines or any other substances, such as foods, preservatives or d Soma hati kamili
TABLET RECOMMENDED DOSE The dosage range for Vascor Tablet is 5-80mg/day, given as a single dose in the evening. Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80mg/day given as a single dose in the evening. The 80mg dose is only recommend- ed in patients at high risk for cardiovascular complications who have not achieved treatment goals on lower doses and when the benefits are expected to outweigh the potential risks. PATIENTS AT HIGH RISK OF CORONARY HEART DISEASE (CHD) OR WITH EXISTING CHD The usual starting dose of Vascor is 40mg given as a single dose in the evening in patients at high risk of CHD (with or without hyperlipidemia), ie, patients with diabetes, history of stroke or other celebrovascular disease, peripheral vessel disease, or with existing CHD, Drug therapy can initiated simultaneously with a standard cholesterol-lowering diet and exercise. PATIENTS WITH HYPERLIPIDEMIA (WHO ARE NOT IN THE RISK CATEGORIES ABOVE) The patient should be placed on a standard cholesterol-lowering diet before receiving Vascor Tablet and should continue on this diet during treatment with Vascor Tablet. The usual starting dose is 20 mg/day given as a single dose a day in the evening. Patients who require a large a reduction in LDL-C (more than 45%) may be started at 40mg/day given as single dose in the evening. Patients with mild to moderate hypercholesterolemia can treated with a starting dose 10mg of Vascor Tablet. Adjustments of dosage, if required, should be made as specified above. PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA The recommended dosage for patients with homozygous familial hypercholesterolemia is VASCOR 40mg/day in the evening. The 80mg dose is recommended when benefits are expected to outweigh the potential risks (see below; CONTRAINDICATION; PRECAUTIONS, Myopathy/Rhabdomyolsis). VASCOR should be used as an adjunct to the lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable. CONCOMITA Soma hati kamili