Ülke: Hollanda
Dil: Hollandaca
Kaynak: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EZETIMIB ; ROSUVASTATINE CALCIUM 0-WATER SAMENSTELLING overeenkomend met ; ROSUVASTATINE
Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)
C10BA06
EZETIMIB ; ROSUVASTATIN CALCIUM 0-WATER COMPOSITION corresponding to ; ROSUVASTATIN
Capsule, hard
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 CHOLECOMB CALCIUM 10 MG/10 MG HARDE CAPSULES CHOLECOMB CALCIUM 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 Cholecomb calcium is and what it is used for 2. What you need to know before you take Cholecomb calcium 3. How to take Cholecomb calcium 4. Possible side effects 5. How to store Cholecomb calcium 6. Contents of the pack and other information 1. WHAT CHOLECOMB CALCIUM IS AND WHAT IT IS USED FOR Cholecomb calcium 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. Cholecomb calcium 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 causing them to narrow. Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart atta Belgenin tamamını okuyun
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cholecomb calcium 10 mg/10 mg harde capsules Cholecomb calcium 20 mg/10 mg harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cholecomb calcium 10 mg/10 mg hard capsules Each capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. Cholecomb calcium 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. Cholecomb calcium 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). Cholecomb calcium 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 Cholecomb calcium 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 Cholecomb calcium 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 Cholecomb calcium. The recommended daily dose is one capsule of the given strength with or without food. 2 Cholecomb calcium are not suitable for initial therapy. Treatment initiation or dose adjustment if necessary, should only be done with the monocomponents and after sett Belgenin tamamını okuyun