Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Simvastatin
Clonmel Healthcare Ltd
C10AA; C10AA01
Simvastatin
40 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; simvastatin
Marketed
2003-07-25
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER SIMTAN 5 MG FILM-COATED TABLETS SIMTAN 10 MG FILM-COATED TABLETS SIMTAN 20 MG FILM-COATED TABLETS SIMTAN 40 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 Simtan is and what it is used for 2. What you need to know before you take Simtan 3. How to take Simtan 4. Possible side effects 5. How to store Simtan 6. Contents of the pack and other information 1. WHAT SIMTAN IS AND WHAT IT IS USED FOR Simtan contains the active substance simvastatin. Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, simvastatin raises levels of “good” cholesterol (HDL cholesterol). Simvastatin 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. Triglyc Read the complete document
Health Products Regulatory Authority 04 March 2024 CRN00DHJ6 Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Simtan 40 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains simvastatin 40 mg Excipient with known effect: Each film-coated tablet contains 298.0 mg Lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. The film-coated tablets can be divided into equal doses. Simtan 40 mg film-coated tablets: White, oblong, biconvex, film-coated tablet, scored on one side and embossed with "SVT" and "40". 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Treatment of primary hypercholesterolaemia (HoFH) 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 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 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 sections 4.4 and 5.1). Hypercholesterolaemia The patient should be placed o Read the complete document