Riik: Malta
keel: inglise
Allikas: Malta Medicines Authority
ROSUVASTATIN
Resolution Chemicals Limited
C10AA07
ROSUVASTATIN
FILM-COATED TABLET
ROSUVASTATIN 20 mg
POM
LIPID MODIFYING AGENTS
Authorised
2014-12-23
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ROSUVASTATIN 5 MG FILM-COATED TABLETS ROSUVASTATIN 10 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. 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 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 can be caused by a disease called atherosclerosis. Atherosclerosis is due to build up of fatty deposits in your arteries. Page 2 of 9 Page 3 of 9 WHY IS IT IMPORTANT TO KEEP TAKING ROSUVASTATIN? Rosuvastatin is used to correct the levels of fatty substances in Lugege kogu dokumenti
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rosuvastatin 20mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20mg rosuvastatin (as rosuvastatin zinc). Excipient with known effect: Each tablet contains 242.4mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Round, slightly biconvex, white or almost white, 9.0 mm diameter tablet, with a stylized ‘E’ and ‘593’ engraved on one side and ‘no engraving on the other side. , 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 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. Rosuvastatin film-coated tablets may be given at any time of day, with or without food. TREATMENT OF HYPERCHOLESTEROLAEMIA Page 2 of 18 The recommended start dose is 5 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 leve Lugege kogu dokumenti