Ülke: Hollanda
Dil: Hollandaca
Kaynak: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 20,8 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 20 mg/stuk
Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)
C10BA06
EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 20,8 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 20 mg/stuk
Capsule, hard
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Rosuvastatin and ezetimibe
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GELATINE (E 441); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMLAURILSULFAAT (E 487); POVIDON K 25 (E 1201); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2018-04-25
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ROSUVASTATINE CALCIUM/EZETIMIBE EGIS 10 MG/10 MG HARDE CAPSULES ROSUVASTATINE CALCIUM/EZETIMIBE EGIS 20 MG/10 MG HARDE CAPSULES rosuvastatin and ezetimibe 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 Rosuvastatine calcium/ezetimibe Egis is and what it is used for 2. What you need to know before you take Rosuvastatine calcium/ezetimibe Egis 3. How to take Rosuvastatine calcium/ezetimibe Egis 4. Possible side effects 5. How to store Rosuvastatine calcium/ezetimibe Egis 6. Contents of the pack and other information 1. WHAT ROSUVASTATINE CALCIUM/EZETIMIBE EGIS IS AND WHAT IT IS USED FOR Rosuvastatine calcium/ezetimibe Egis contains two different active substances in one capsule. One of the active substances is rosuvastatin, belonging to the group of so-called statins, the other active substance is ezetimibe. Rosuvastatine calcium/ezetimibe Egis is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in your blood. In addition, it also raises levels of “good” cholesterol (HDL cholesterol). This medicine works to reduce your cholesterol in two ways: it reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. _ _ For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blo Belgenin tamamını okuyun
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rosuvastatine calcium/ezetimibe Egis 10 mg/10 mg harde capsules Rosuvastatine calcium/ezetimibe Egis 20 mg/10 mg harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rosuvastatine calcium/ezetimibe Egis 10 mg/10 mg hard capsules Each capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. Rosuvastatine calcium/ezetimibe Egis 20 mg/10 mg hard capsules Each capsule contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. Rosuvastatine calcium/ezetimibe Egis 10 mg/10 mg hard capsules: Unmarked self-closing Coni Snap type, size 0, hard gelatin capsule with yellow coloured cap and yellow coloured body filled with two tablets. The length of the capsule is about 21.7 mm (± 0.3 mm). Rosuvastatine calcium/ezetimibe Egis 20 mg/10 mg hard capsules: Unmarked self-closing Coni Snap type, size 0, hard gelatin capsule with caramel coloured cap and yellow coloured body filled with two tablets. The length of the capsule is about 21.7 mm (± 0.3 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rosuvastatine calcium/ezetimibe Egis is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Rosuvastatine calcium/ezetimibe Egis is indicated in adult patients whose hypercholesterolemia is adequately controlled with separately administered monocomponent preparations of the same doses as the recommended combination. The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Rosuvastatine calcium/ezetimibe Egis. The recommended daily dose is one capsule of the given strength with or without food. Belgenin tamamını okuyun