Država: Nizozemska
Jezik: nizozemščina
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ATORVASTATINE CALCIUM 3-WATER 43,3 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 40 mg/stuk ; EZETIMIB 10 mg/stuk
Egis Pharmaceuticals Kereszturi ut 30-38 H-1106 BUDAPEST (HONGARIJE)
ATORVASTATINE CALCIUM 3-WATER 43,3 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 40 mg/stuk ; EZETIMIB 10 mg/stuk
Capsule, hard
CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; SACCHAROSE ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; SACCHAROSE ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; SACCHAROSE ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EZETIMIBE/ATORVASTATINE EGIS 10 MG/10 MG HARDE CAPSULES EZETIMIBE/ATORVASTATINE EGIS 10 MG/20 MG HARDE CAPSULES EZETIMIBE/ATORVASTATINE EGIS 10 MG/40 MG HARDE CAPSULES ezetimibe and atorvastatin 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 Ezetimibe/Atorvastatine Egis is and what it is used for 2. What you need to know before you take Ezetimibe/Atorvastatine Egis 3. How to take Ezetimibe/Atorvastatine Egis 4. Possible side effects 5. How to store Ezetimibe/Atorvastatine Egis 6. Contents of the pack and other information 1. WHAT EZETIMIBE/ATORVASTATINE EGIS IS AND WHAT IT IS USED FOR Ezetimibe/Atorvastatine Egis contains two different active substances in one capsule. One of the active substances is ezetimibe, the other active substance is atorvastatin, belonging to the group of so called statins. Ezetimibe/Atorvastatine Egis is a medicine used in adults 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 ve Preberite celoten dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ezetimibe/Atorvastatine Egis 10 mg/10 mg harde capsules Ezetimibe/Atorvastatine Egis 10 mg/20 mg harde capsules Ezetimibe/Atorvastatine Egis 10 mg/40 mg harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ezetimibe/Atorvastatine Egis 10 mg/10 mg harde capsules Each hard capsule contains 10 mg ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate). Ezetimibe/Atorvastatine Egis 10 mg/20 mg harde capsules Each hard capsule contains 10 mg ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate). Ezetimibe/Atorvastatine Egis 10 mg/40 mg harde capsules Each hard capsule contains 10 mg ezetimibe and 40 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipient with known effect Each Ezetimibe/Atorvastatine Egis 10 mg/10 mg capsule contains 13 mg sucrose. Each Ezetimibe/Atorvastatine Egis 10 mg/20 mg capsule contains 26 mg sucrose. Each Ezetimibe/Atorvastatine Egis 10 mg/40 mg capsule contains 51.5 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules, hard Ezetimibe/Atorvastatine Egis 10 mg/10 mg hard capsules: Unmarked self-closing size 0, hard gelatin capsule with caramel coloured cap and yellow coloured body, filled with pellets and a tablet. The length of the capsule is about 21.7 mm. Ezetimibe/Atorvastatine Egis 10 mg/20 mg hard capsules: Unmarked self-closing size 0, hard gelatin capsule with reddish brown coloured cap and yellow coloured body, filled with pellets and a tablet. The length of the capsule is about 21.7 mm. Ezetimibe/Atorvastatine Egis 10 mg/40 mg hard capsules: Unmarked self-closing size 0, hard gelatin capsule with dark brown coloured cap and yellow coloured body, filled with pellets and a tablet. The length of the capsule is about 21.7 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ezetimibe/Atorvastatine Egis hard capsules are indicated as adjunct to diet as substitution therapy for treatment of adults with primary hypercholesterol Preberite celoten dokument