Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Simvastatin
Phoenix Healthcare Distribution Ltd
C10AA01
Simvastatin
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000
PACKAGE LEAFLET: INFORMATION FOR THE USER SIMVADOR 10MG, 20MG, 40MG AND 80MG 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. • Simvador is used to lower levels of cholesterol and triglycerides in your blood and can help reduce your risk of developing coronary heart disease. (See Section 1 ’What Simvador is and what it is used for’). • Simvador can cause serious muscle problems in a very small number of patients. If you suf fer from unexplained pain, tenderness or weakness in your muscles STOP TAKING the medicine and talk to your doctor at once. • DO NOT TAKE this medicine if you are already taking medicines for fungal infections (such as itraconazole, ketoconazole, voriconazole or posaconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir and saquinavir), medicines for Hepatitis C virus infection (such as boceprevir or telaprevir), antibiotics (such as erythromycin, clarithromycin, telithromycin), nefazodone which is used to treat depression, gemfibrozil used for lowing cholesterol, ciclosporin a medicine often used in organ transplant patients, danazol a man-made hormone used to treat endometriosis, fusidic acid (if you are taking, or in the last 7 days have taken) used to treat bacterial infections. (See Section 2 ‘Taking other medicines’). • If you are pregnant or trying to get pregnant or breast feeding you MUST NOT take Simvador (See Section 2 ’Before you take Simvador’). • If you have high blood pressure, high levels of fats or sugars in your blood o Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Simvastatin 10 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of the active ingredient simvastatin. Excipient with known effect: Lactose monohydrate (tablet core and tablet coat) 72.03 mg per film-coated tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Simvastatin 10 mg film-coated tablets are presented as “dark peach to pink” coloured, oval shaped, film-coated tablets with “G” on one side and “SM” scoreline “10” on the other 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 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 Prečítajte si celý dokument