Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ROSUVASTATINE CALCIUM 0-WATER SAMENSTELLING overeenkomend met ; ROSUVASTATINE
Stada Arzneimittel AG
C10AA07
ROSUVASTATIN CALCIUM 0-WATER COMPOSITION corresponding to ; ROSUVASTATIN
Filmomhulde tablet
CELLULOSE, GEPOEDERD (E 460) ; COPOVIDON ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Rosuvastatin
Hulpstoffen: CELLULOSE, GEPOEDERD (E 460); COPOVIDON; CROSPOVIDON (E 1202); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2015-02-12
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Rosuvastatine STADA 5mg, filmomhulde tabletten Rosuvastatine STADA 10mg, filmomhulde tabletten Rosuvastatine STADA 20mg, filmomhulde tabletten 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 PRODUCT NAME is and what it is used for 2. What you need to know before you take PRODUCT NAME 3. How to take PRODUCT NAME 4. Possible side effects 5. How to store PRODUCT NAME 6. Contents of the pack and other information 1. WHAT PRODUCT NAME IS AND WHAT IT IS USED FOR PRODUCT NAME contains the active ingredient rosuvastatin, which belongs to a group of medicines called statins. YOU HAVE BEEN PRESCRIBED PRODUCT NAME BECAUSE: You have a high cholesterol level. This means you are at risk from a heart attack or stroke. PRODUCT NAME 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 PRODUCT NAME. 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 PRODUCT NAME PRODUCT NAME is used to correct the levels of fatty substances in the bloo Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rosuvastatine STADA 5mg, filmomhulde tabletten Rosuvastatine STADA 10mg, filmomhulde tabletten Rosuvastatine STADA 20mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 mg: Each film-coated tablet contains 5 mg rosuvastatin (as rosuvastatin calcium). Excipient with known effect: Each tablet contains 41 mg lactose monohydrate. 10 mg: Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium). Excipient with known effect: Each tablet contains 83 mg lactose monohydrate. 20 mg: Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium). Excipient with known effect: Each tablet contains 165 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. PRODUCT NAME 5 mg are white, round, biconvex film-coated tablets with a diameter of 5 mm. PRODUCT NAME 10 mg are white, round, biconvex film-coated tablets with a diameter of 7 mm. PRODUCT NAME 20 mg are white, round, biconvex film-coated tablets with a diameter of 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 inadequate. Adults, adolescents and children aged 6 years or older with 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 p Lees het volledige document