Country: Малта
Језик: Енглески
Извор: Medicines Authority
KRKA DD Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia
C10AA07
ROSUVASTATIN 40 mg
FILM-COATED TABLET
ROSUVASTATIN 40 mg
POM
LIPID MODIFYING AGENTS
Authorised
2023-12-06
Page 1 of 9 PACKAGE LEAFLET Page 2 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER SORVASTA 5 MG FILM-COATED TABLETS SORVASTA 10 MG FILM-COATED TABLETS SORVASTA 20 MG FILM-COATED TABLETS SORVASTA 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 Sorvasta is and what it is used for 2. What you need to know before you take Sorvasta 3. How to take Sorvasta 4. Possible side effects 5. How to store Sorvasta 6. Contents of the pack and other information 1. WHAT SORVASTA IS AND WHAT IT IS USED FOR Sorvasta belongs to a group of medicines called statins. You have been prescribed Sorvasta because: - You have a HIGH CHOLESTEROL LEVEL . This means you are AT RISK FROM A HEART ATTACK OR STROKE . Sorvasta 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 Sorvasta. 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 you arteries. WHY IS IT IMPORTANT TO KEEP TAKING SORVASTA? Sorvasta is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol. Pag Прочитајте комплетан документ
Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 20 1. NAME OF THE MEDICINAL PRODUCT Sorvasta 5 mg film-coated tablets Sorvasta 10 mg film-coated tablets Sorvasta 20 mg film-coated tablets Sorvasta 40 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg rosuvastatin (as rosuvastatin calcium). Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium). Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium). Each film-coated tablet contains 40 mg rosuvastatin (as rosuvastatin calcium). Excipient with known effect: Each 5 mg film-coated tablet contains 20.0 mg lactose. Each 10 mg film-coated tablet contains 40.0 mg lactose. Each 20 mg film-coated tablet contains 80.0 mg lactose. Each 40 mg film-coated tablet contains 160.0 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 5 mg film-coated tablets: Brown red, round, slightly biconvex, film-coated tablets with bevelled edges, engraved with number 5 on one side of the tablet (diameter: 6 mm). 10 mg film-coated tablets: Brownish yellow, round, slightly biconvex, film-coated tablets with bevelled edges, engraved with number 10 on one side of the tablet (diameter: 8 mm). 20 mg film-coated tablets: White or almost white, round, slightly biconvex film-coated tablets with bevelled edges, engraved with number 20 on one side of the tablet (diameter: 10 mm). 40 mg film-coated tablets: Brownish yellow, biconvex, capsule-shaped film-coated tablets, engraved with number 40 on one side of the tablet (dimensions: 16 mm x 9 mm). _ _ 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 inade Прочитајте комплетан документ