Država: Nizozemska
Jezik: nizozemski
Izvor: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EZETIMIB 10 mg/stuk ; ROSUVASTATINE ZINK 5,34 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 5 mg/stuk
Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)
C10BA06
EZETIMIB 10 mg/stuk ; ROSUVASTATINE ZINK 5,34 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 5 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) ; 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) ; 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); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMLAURILSULFAAT (E 487); POVIDON K 25 (E 1201); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ROSUVASTATINE/EZETIMIBE EGIS 5 MG/10 MG HARDE CAPSULES ROSUVASTATINE/EZETIMIBE EGIS 10 MG/10 MG HARDE CAPSULES ROSUVASTATINE/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/ezetimibe EGIS is and what it is used for 2. What you need to know before you take Rosuvastatine/ezetimibe EGIS 3. How to take Rosuvastatine/ezetimibe EGIS 4. Possible side effects 5. How to store Rosuvastatine/ezetimibe EGIS 6. Contents of the pack and other information 1. WHAT ROSUVASTATINE/EZETIMIBE EGIS IS AND WHAT IT IS USED FOR Rosuvastatine/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/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 blood vessels causin Pročitajte cijeli dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rosuvastatine/ezetimibe EGIS 5 mg/10 mg harde capsules Rosuvastatine/ezetimibe EGIS 10 mg/10 mg harde capsules Rosuvastatine/ezetimibe EGIS 20 mg/10 mg harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rosuvastatine/ezetimibe EGIS 5 mg/10 mg hard capsules Each capsule contains 5 mg of rosuvastatin (as rosuvastatin zinc) and 10 mg of ezetimibe. Rosuvastatine/ezetimibe EGIS 10 mg/10 mg hard capsules Each capsule contains 10 mg of rosuvastatin (as rosuvastatin zinc) and 10 mg of ezetimibe. _ _ Rosuvastatine/ezetimibe EGIS 20 mg/10 mg hard capsules Each capsule contains 20 mg of rosuvastatin (as rosuvastatin zinc) and 10 mg of ezetimibe. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. Rosuvastatine/ezetimibe EGIS 5 mg/10 mg hard capsules: Unmarked self-closing Coni Snap type, size 0, hard gelatin capsule with yellow coloured cap and white coloured body filled with two tablets: one piece of white or almost white round, flat and bevel-edged _Ezetimibe 10 mg tablet _with a stylized E sign on one side of the tablet and 612 code on the other side; one piece of white or almost white, round _Rosuvastatin _ _5 mg tablet_ with mark on one side of the tablet and no mark on the other side. The length of the capsule is about 21.7 mm (± 0.5 mm). Rosuvastatine/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: one piece of white or almost white round, flat and bevel-edged _Ezetimibe 10 mg tablet_ with a stylized E sign on one side of the tablet and 612 code on the other side; one piece of white or almost white round _Rosuvastatin _ _10 mg tablet_ with mark on one side of the tablet and no mark on the other side. The length of the capsule is about 21.7 mm (± 0.5 mm). Rosuvastatine/ezetimibe EGIS 20 mg/10 mg hard capsules: Unmarked self-closing Coni Snap type, size 0, hard gelatin ca Pročitajte cijeli dokument