País: Països Baixos
Idioma: neerlandès
Font: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ROSUVASTATINE CALCIUM 0-WATER 20,8 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 20 mg/stuk
Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)
C10AA07
ROSUVASTATINE CALCIUM 0-WATER 20,8 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 20 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRINATRIUMCITRAAT 2-WATER (E 331),
Oraal gebruik
Rosuvastatin
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); TRINATRIUMCITRAAT 2-WATER (E 331);
2017-06-02
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ROSUVASTATINE DENK 5 MG, FILMOMHULDE TABLETTEN ROSUVASTATINE DENK 10 MG, FILMOMHULDE TABLETTEN ROSUVASTATINE DENK 20 MG, FILMOMHULDE TABLETTEN ROSUVASTATINE DENK 40 MG 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 [Invented name] is and what it is used for 2. What you need to know before you take [Invented name] 3. How to take [Invented name] 4. Possible side effects 5. How to store [Invented name] 6. Contents of the pack and other information 1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR [Invented name] belongs to a group of medicines called statins. You have been prescribed [Invented name] because: • You have a HIGH CHOLESTEROL LEVEL . This means you are AT RISK FROM A HEART ATTACK OR STROKE . [Invented 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 [Invented 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 [INVENTED NAME] [Invented name] is used to correct Llegiu el document complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rosuvastatine Denk 5 mg, filmomhulde tabletten Rosuvastatine Denk 10 mg, filmomhulde tabletten Rosuvastatine Denk 20 mg, filmomhulde tabletten Rosuvastatine Denk 40 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Invented name] 5 mg film-coated tablets: Each film-coated tablet contains 5 mg rosuvastatin (as rosuvastatin calcium). [Invented name] 10 mg film-coated tablets: Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium). [Invented name] 20 mg film-coated tablets: Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium). [Invented name] 40 mg film-coated tablets: Each film-coated tablet contains 40 mg rosuvastatin (as rosuvastatin calcium). Excipient with known effect: lactose monohydrate. [Invented name] 5 mg film-coated tablets: Each film-coated tablet contains 41.572 mg lactose monohydrate. [Invented name] 10 mg film-coated tablets: Each film-coated tablet contains 83.145 mg lactose monohydrate. [Invented name] 20 mg film-coated tablets: Each film-coated tablet contains 166.29 mg lactose monohydrate. [Invented name] 40 mg film-coated tablets: Each film-coated tablet contains 332.58 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. [Invented name] 5 mg film-coated tablets: White or almost white, round and biconvex film-coated tablets, engraving “5” on the one side, with a diameter of 4.9 mm – 5.3 mm. [Invented name] 10 mg film-coated tablets: White or almost white, round and biconvex film-coated tablets, engraving “10” on the one side, with a diameter of 6.9 mm – 7.3 mm. [Invented name] 20 mg film-coated tablets: White or almost white, round and biconvex film-coated tablets, engraving “20” on the one side, with a diameter of 8.9 mm – 9.3 mm. [Invented name] 40 mg film-coated tablets: White or almost white, oblong and biconvex film-coated tablets, with a width of 6.4 mm – 6.8 mm and a le Llegiu el document complet