Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Rosuvastatin calcium
DSM Sinochem Pharmaceuticals Netherlands B.V.
C10AA; C10AA07
Rosuvastatin calcium
20 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; rosuvastatin
Not marketed
2016-10-14
ROSUVASTATIN 5 MG, 10 MG, 20 MG, 40 MG FILM-COATED TABLET 1.3.1 SMPC, LABELLING AND PACKAGE LEAFLET DSM SINOCHEM PHARMACEUTICALS NETHERLANDS B.V Version no. 1.4 Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER ROSUVASTATIN5 MG FILM-COATED TABLETS ROSUVASTATIN Đọc toàn bộ tài liệu10 MG FILM-COATED TABLETS ROSUVASTATIN 20 MG FILM-COATED TABLETS ROSUVASTATIN 40 MG FILM-COATED TABLETS ROSUVASTATIN 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 or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Rosuvastatin is and what it is used for 2. What you need to know before you take Rosuvastatin 3. How to take Rosuvastatin 4. Possible side effects 5. How to store Rosuvastatin 6. Contents of the pack and other information. 1. WHAT ROSUVASTATIN IS AND WHAT IT IS USED FOR Rosuvastatin belongs to a group of medicines called statins. YOU HAVE BEEN PRESCRIBED ROSUVASTATIN BECAUSE: - You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Rosuvastatin is used in adults, adolescents and children 6 years or older to treat high cholesterol. You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking Rosuvastatin . Or - You have other factors that increase your risk of having a heart attack, stroke or related health problems. Heart attack, stroke and other problems
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rosuvastatin DSM Sinochem 20 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of rosuvastatin (as Rosuvastatin Calcium). Excipients with known effect: Each film-coated tablet contains 160.00 mg of lactose monohydrate, sunset yellow FCF (E110) and Allura Red AC (E129). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Pink, round, biconvex, film-coated tablets, embossed ‘R’ on one side and ‘20’ on the other side and 9.0 mm±0.5 mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Treatment of hypercholesterolaemia_ Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. _Prevention of Cardiovascular Events_ Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event (see Section 5.1), as an adjunct to correction of other risk factors. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose should be individualised according to the goal of therapy and patient response, using current consensus guidelines. _Treatment of hypercholesterolaemia_ The recommended start dose is 5 mg or 10 mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's cholesterol level and future cardiovascular risk Đọc toàn bộ tài liệu