Država: Malta
Jezik: engleski
Izvor: Medicines Authority
ROSUVASTATIN
Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain
C10AA07
ROSUVASTATIN 10 mg
FILM-COATED TABLET
ROSUVASTATIN 10 mg
POM
LIPID MODIFYING AGENTS
Authorised
2017-05-26
1 B. PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ROSUVASTATIN GALENICUM 5 MG FILM-COATED TABLETS ROSUVASTATIN GALENICUM 10 MG FILM-COATED TABLETS ROSUVASTATIN GALENICUM 20 MG FILM-COATED TABLETS ROSUVASTATIN GALENICUM 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 childrens 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. WHY IT IS IMPORTANT TO KEEP TAKING ROSUVASTATIN Rosuvastatin Galenicum is used to co Pročitajte cijeli dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Rosuvastatin Galenicum 5 mg film-coated tablets. Rosuvastatin Galenicum 10 mg film-coated tablets. Rosuvastatin Galenicum 20 mg film-coated tablets. Rosuvastatina Galenicum 40 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 mg: Each tablet contains 5 mg rosuvastatin (as rosuvastatin calcium). 10 mg: Each tablet contains 10 mg rosuvastatin (as rosuvastatin calcium). 20 mg: Each tablet contains 20 mg rosuvastatin (as rosuvastatin calcium). 40 mg: Each tablet contains 40 mg rosuvastatin (as rosuvastatin calcium). Excipient(s) with known effect 5 mg: lactose 16.6 mg; sunset yellow FCF (E110); tartrazine (E102) and indigo carmine (E132). 10 mg: lactose 33.3 mg; sunset yellow FCF (E110); tartrazine (E102); indigo carmine (E132) and Allura red AC (E129). 20 mg: lactose 66.5 mg; sunset yellow FCF (E110); tartrazine (E102); indigo carmine (E132) and Allura red AC (E129). 40 mg: lactose 133.0 mg; sunset yellow FCF (E110); tartrazine (E102); indigo carmine (E132) and Allura red AC (E129). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 5 mg: Film-coated tablet. Yellow, round, biconvex film-coated tablets 10 mg: Film-coated tablet. Pink, round, biconvex film – coated tablets. 20 mg: Film-coated tablet. Pink, oval, biconvex film-coated tablets, with score line on the one side The tablet can be divided into equal doses. 40 mg: Film-coated tablet. Pink, oblong, biconvex film-coated tablets, with score line on the one side The tablet can be divided into equal doses. 3 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. Adults, adolescents and children aged 6 Pročitajte cijeli dokument