Šalis: Malta
kalba: anglų
Šaltinis: Malta Medicines Authority
ROSUVASTATIN
Sigillata Limited (Ireland) Inniscarra, Main Street, Rathcoole, Co. Dublin D24 E029 , Ireland
C10AA07
ROSUVASTATIN 10 mg
FILM-COATED TABLET
ROSUVASTATIN 10 mg
POM
LIPID MODIFYING AGENTS
Withdrawn
2012-04-09
Page 1 of 9 PACKAGE LEAFLET Page 2 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ TINTAROS 5 MG FILM-COATED TABLETS, TINTAROS 10 MG FILM-COATED TABLETS, TINTAROS 20 MG FILM-COATED TABLETS, TINTAROS 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 Tintaros is and what it is used for 2. What you need to know before you take Tintaros 3. How to take Tintaros 4. Possible side effects 5. How to store Tintaros 6. Contents of the pack and other information 1. WHAT TINTAROS IS AND WHAT IT IS USED FOR Tintaros belongs to a group of medicines called statins. You have been prescribed Tintaros because: - You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Tintaros 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 cholestrol-lowering diet and exercise while you are taking Tintaros. 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 a build up of fatty deposits in your arteris. WHY IT IS IMPORTANT TO KEEP TAKING TINTAROS Tintaros is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholester Perskaitykite visą dokumentą
Page 1 of 21 _ _ SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 21 1. NAME OF THE MEDICINAL PRODUCT_ _ Tintaros 5 mg film-coated tablets. Tintaros 10 mg film-coated tablets. Tintaros 20 mg film-coated tablets. Tintaros 40 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 10 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 20 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 40 mg rosuvastatin (as rosuvastatin calcium). Excipients with known effect: Each 5 mg tablet contains 32,15 mg lactose monohydrate. Each 10 mg tablet contains 64,30 mg lactose monohydrate. Each 20 mg tablet contains 128,60 mg lactose monohydrate. Each 40 mg tablet contains 257,21 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 5mg tablets: White, round, 5.5mm, biconvex, film-coated tablets with “ST 1” engraved on one side. 10mg tablets: Pink, round, 7mm, biconvex, film-coated tablets with “ST 2” engraved on one side. 20mg tablets: Pink, round, 9mm, biconvex, film-coated tablets with “ST 3” engraved on one side. 40mg tablets: Pink, oval, 16mm x 8mm, biconvex, film-coated tablets with “ST 4” engraved on one side. Page 3 of 21 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TREATMENT OF HYPERCHOLESTEROLAEMIA Tintaros is indicated in 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. Tintaros is indicated in 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 Tintaros is indicated in prevention of major cardiovascular Perskaitykite visą dokumentą