Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Malta Medicines Authority
ROSUVASTATIN
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
C10AA07
ROSUVASTATIN 20 mg
FILM-COATED TABLET
ROSUVASTATIN 20 mg
POM
LIPID MODIFYING AGENTS
Authorised
2013-02-12
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER ROSUVASTATIN AUROBINDO 5 MG FILM-COATED TABLETS ROSUVASTATIN AUROBINDO 10 MG FILM-COATED TABLETS ROSUVASTATIN AUROBINDO 20 MG FILM-COATED TABLETS ROSUVASTATIN AUROBINDO 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 Aurobindo is and what it is used for 2. What you need to know before you take Rosuvastatin Aurobindo 3. How to take Rosuvastatin Aurobindo 4. Possible side effects 5. How to store Rosuvastatin Aurobindo 6. Contents of the pack and other information 1. WHAT ROSUVASTATIN AUROBINDO IS AND WHAT IT IS USED FOR Rosuvastatin Aurobindo belongs to a group of medicines called statins. YOU HAVE BEEN PRESCRIBED ROSUVASTATIN AUROBINDO BECAUSE: • You have a HIGH CHOLESTEROL LEVEL . This means you are AT RISK FROM A HEART ATTACK OR STROKE . Rosuvastatin Aurobindo 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 doing 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 Aurobindo. 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 Izlasiet visu dokumentu
Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rosuvastatin Aurobindo 5 mg film-coated tablets Rosuvastatin Aurobindo 10 mg film-coated tablets Rosuvastatin Aurobindo 20 mg film-coated tablets Rosuvastatin Aurobindo 40 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg, 10 mg, 20 mg or 40 mg rosuvastatin (as rosuvastatin calcium). Excipients with known effect Each 5 mg tablet contains 22.939 mg lactose monohydrate, 0.007 mg allura red AC and 0.006 mg Sunset yellow FCF. Excipients with known effect Each 10 mg tablet contains 45.878 mg lactose monohydrate, 0.015 mg allura red AC and 0.013 mg Sunset yellow FCF. Excipients with known effect Each 20 mg tablet contains 91.755 mg lactose monohydrate, 0.029 mg allura red AC and 0.025 mg Sunset yellow FCF. Excipients with known effect Each 40 mg tablet contains 183.510 mg lactose monohydrate, 0.059 mg allura red AC and 0.051 mg Sunset yellow FCF. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Rosuvastatin Aurobindo tablets 5 mg: Pink coloured, oval shaped, biconvex film-coated tablets, debossed with ‘J’ on one side and ‘53’ on the other side. The size is 5.8 mm X 3.8 mm. Rosuvastatin Aurobindo tablets 10 mg: Pink coloured, round shaped [diameter 5.8 mm], biconvex film-coated tablets, debossed with ‘J’ on one side and ‘54’ on the other side. Rosuvastatin Aurobindo tablets 20 mg: Pink coloured, round shaped [diameter 7.4 mm], biconvex film-coated tablets, debossed with ‘J’ on one side and ‘55’ on the other side. Rosuvastatin Aurobindo tablets 40 mg: Page 2 of 20 Pink coloured, oval shaped, biconvex film-coated tablets, debossed with ‘J’ on one side and ‘56’ on the other side. The size is 12.1 mm X 7 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 except heterozygous familial hypercho Izlasiet visu dokumentu