Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Simvastatin
Bristol Laboratories Ltd
C10AA01
Simvastatin
40mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5060013942471
Simvastatin (POM) 10,20 40 mg Insert SAME SIZE ARTWORK 430 x 150 mm Front 430 mm IXXXXXX PACKAGE LEAFLET: INFORMATION FOR THE USER SIMVASTATIN 10 MG TABLETS SIMVASTATIN 20 MG TABLETS SIMVASTATIN 40 MG TABLETS 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 illnessare 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 Simvastatin Tablets are and what they are used for 2. What you need to know before you take Simvastatin Tablets 3. How to take Simvastatin Tablets 4. Possible side effects 5. How to store Simvastatin Tablets 6. Contents of the pack and other information. 1. What Simvastatin Tablets are and what they are used for Simvastatin Tablets belongs to a group of medicines known as ‘statins’ or ‘HMG-CoA reductase inhibitors’. Simvastatin Tablets are used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin Tablets raises levels of “good” cholesterol (HDL cholesterol). 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 Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Simvastatin 40 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40mg of simvastatin Excipient with known effect: Also contains 298mg of lactose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablets White, oblong, biconvex film-coated tablets, scored on one side, debossed with “40” on the scored side and with “SVT” on the opposite side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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 cardio protective therapy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage range is 5-80 mg/day of simvastatin given orally 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 80 mg/day given as a single dose in the evening. The 80-mg dose is only recommended in patients with severe hypercholesterolaemia and at high risk for cardiovascular complications, who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks (see section 4.4. and 5.1). _Hypercholestrolaemia _ The patient should be placed on a standard cholesterol-lowering diet, and s Leggi il documento completo