País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Simvastatin
Organon Pharma (UK) Ltd
C10AA01
Simvastatin
80mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5013945182767
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZOCOR ® 80 MG FILM-COATED TABLETS Simvastatin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What ZOCOR is and what it is used for 2. What you need to know before you take ZOCOR 3. How to take ZOCOR 4. Possible side effects 5. How to store ZOCOR 6. Contents of the pack and other information 1. WHAT ZOCOR IS AND WHAT IT IS USED FOR ZOCOR contains the active substance simvastatin. ZOCOR is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, ZOCOR raises levels of “good” cholesterol (HDL cholesterol). ZOCOR is a member of the class of medicines called statins. Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol. LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke. HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease. Triglycerides are another form of fat in your blood that may increase your risk for heart disease. You should stay on a cholesterol-lowe Leer el documento completo
OBJECT 1 ZOCOR 10MG FILM-COATED TABLETS Summary of Product Characteristics Updated 15-May-2018 | Merck Sharp & Dohme Limited 1. Name of the medicinal product Zocor ® 10 mg, film-coated tablets. Zocor ® 20 mg, film-coated tablets. Zocor ® 40 mg, film-coated tablets. Zocor ® 80 mg, film-coated tablets. 2. Qualitative and quantitative composition Each tablet contains 10 mg of simvastatin. Each tablet contains 20 mg of simvastatin. Each tablet contains 40 mg of simvastatin. Each tablet contains 80 mg of simvastatin. Excipient(s) with known effect For the full list of excipients, see section 6.1. Each 10 mg tablet contains 70.7 mg of lactose monohydrate. Each 20 mg tablet contains 141.5 mg of lactose monohydrate. Each 40 mg tablet contains 283.0 mg of lactose monohydrate. Each 80 mg tablet contains 565.8 mg of lactose monohydrate. 3. Pharmaceutical form Film-coated tablet. The peach-coloured, oval-shaped tablets marked 'MSD 735' contain 10 mg simvastatin. The tan-coloured, oval-shaped tablets marked 'MSD 740' contain 20 mg simvastatin. The brick-red coloured, oval-shaped tablets marked 'MSD 749' contain 40 mg simvastatin. The brick-red coloured, capsule-shaped tablets marked '543' on one side and '80' on the other contain 80 mg simvastatin. 4. Clinical particulars 4.1 Therapeutic indications Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Treatment of homozygous familial hypercholesterolaemia (HoFH) as an adjunct to diet and other lipid- lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. Cardiovascular prevention Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy (see section 5.1). 4.2 Po Leer el documento completo