Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Simvastatin
Bluefish Pharmaceuticals AB
C10AA; C10AA01
Simvastatin
40 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; simvastatin
Marketed
2008-11-21
PACKAGE LEAFLET: INFORMATION FOR THE USER SIMVASTATIN BLUEFISH 10 MG FILM-COATED TABLETS SIMVASTATIN BLUEFISH 20 MG FILM-COATED TABLETS SIMVASTATIN BLUEFISH 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 Simvastatin Bluefish is and what it is used for 2. What you need to know before you take Simvastatin Bluefish 3. How to take Simvastatin Bluefish 4. Possible side effects 5. How to store Simvastatin Bluefish 6. Contents of the pack and other information 1. WHAT SIMVASTATIN BLUEFISH IS AND WHAT IT IS USED FOR Simvastatin Bluefish contains the active substance simvastatin. Simvastatin Bluefish 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 Bluefish raises levels of “good” cholesterol (HDL cholesterol). Simvastatin Bluefish 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 becaus Прочитајте комплетан документ
Health Products Regulatory Authority 11 May 2023 CRN00DCFH Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Simvastatin Bluefish 40mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg simvastatin. Excipient(s) with known effect: Lactose monohydrate One film-coated tablet contains 280 mg lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-Coated Tablet. Pink, round and biconvex film-coated tablets with “A” debossed on one side and “03” on the other side. 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 (such as 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 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 on a standard cholesterol-lowerin Прочитајте комплетан документ