Country: Netherlands
Language: Dutch
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ROSUVASTATINE CALCIUM 0-WATER SAMENSTELLING overeenkomend met ; ROSUVASTATINE
Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN
C10AA07
ROSUVASTATIN CALCIUM 0-WATER COMPOSITION corresponding to ; ROSUVASTATIN
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Rosuvastatin
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2016-08-22
MODULE 1.3 Product Information Version: 2019-09 MODULE 1.3.1 Package Leaflet Replaces: 2019-04 1 PACKAGE LEAFLET: INFORMATION FOR THE USER ROSUVASTATIN APOTEX 5 MG FILMOMHULDE TABLETTEN ROSUVASTATIN APOTEX 10 MG FILMOMHULDE TABLETTEN ROSUVASTATIN APOTEX 20 MG FILMOMHULDE TABLETTEN ROSUVASTATIN APOTEX 40 MG FILMOMHULDE TABLETTEN Rosuvastatin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Apotex is and what it is used for 2. What you need to know before you take Rosuvastatin Apotex 3. How to take Rosuvastatin Apotex 4. Possible side effects 5. How to store Rosuvastatin Apotex 6. Contents of the pack and other information 1. WHAT ROSUVASTATIN APOTEX IS AND WHAT IT IS USED FOR Rosuvastatin Apotex 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 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 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 y Read the complete document
MODULE 1.3 Product Information Version: 2019-09 MODULE 1.3.1 Summary of Product Characteristics Replaces : 2019-4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rosuvastatine Apotex 5 mg filmomhulde tabletten Rosuvastatine Apotex 10 mg filmomhulde tabletten Rosuvastatine Apotex 20 mg filmomhulde tabletten Rosuvastatine Apotex 40 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rosuvastatine Apotex 5 mg filmomhulde tabletten : Each film- coated tablet contains 5.20 mg rosuvastatin calcium equivalent to 5 mg rosuvastatin. Excipient(s) with known effect: Lactose monohydrate. Each tablet contains 68.70 mg lactose monohydrate. Rosuvastatine Apotex 10 mg filmomhulde tabletten : Each film- coated tablet contains 10.40 mg rosuvastatin calcium equivalent to 10 mg rosuvastatin. Excipient(s) with known effect: Lactose monohydrate. Each tablet contains 100.45 mg lactose monohydrate. Rosuvastatine Apotex 20 mg filmomhulde tabletten : Each film- coated tablet contains 20.79 mg rosuvastatin calcium equivalent to 20 mg rosuvastatin. Excipient(s) with known effect: Lactose monohydrate. Each tablet contains 200.91 mg lactose monohydrate. Rosuvastatine Apotex 40 mg filmomhulde tabletten : Each film- coated tablet contains 41.60 mg rosuvastatin calcium equivalent to 40 mg rosuvastatin. Excipient(s) with known effect: Lactose monohydrate. Each tablet contains 180.10 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM filmcoated tablet Rosuvastatine Apotex 5 mg filmomhulde tabletten are yellow, (6.35 mm)_ _ round, biconvex, film coated tablets, engraved ‘APO’ on one side and ’ROS’ over ‘5’ on the other side. Rosuvastatine Apotex 10 mg filmomhulde tabletten are pink, (7.14mm) round, biconvex, film- coated tablets, engraved ‘APO’ on one side and ’ROS’ over ‘10’ on the other side. Rosuvastatine Apotex 20 mg filmomhulde tabletten are pink, (9.52 mm) round, biconvex, film- coated tablets, engraved ‘APO’ on one side and ’ROS Read the complete document