Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EPLERENON 50 mg/stuk
Pfizer B.V. Rivium Westlaan 142 2909 LD CAPELLE A/D IJSSEL
C03DA04
EPLERENON 50 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Eplerenone
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
NLD 24C01 1 NLD 24C01 PACKAGE LEAFLET: INFORMATION FOR THE USER EPLERENON VIATRIS 25 MG, FILMOMHULDE TABLETTEN EPLERENON VIATRIS 50 MG, FILMOMHULDE TABLETTEN eplerenone 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 EPLERENON VIATRIS is and what it is used for 2. What do you need to know before you take EPLERENON VIATRIS 3. How to take EPLERENON VIATRIS 4. Possible side effects 5. How to store EPLERENON VIATRIS 6. Contents of the pack and other information 1. WHAT EPLERENON VIATRIS IS AND WHAT IT IS USED FOR EPLERENONE belongs to a group of medicines known as selective aldosterone blocking agents. These blocking agents inhibit the action of aldosterone, a substance produced within the body, which controls your blood pressure and heart function. High levels of aldosterone can cause changes in your body that lead to heart failure. EPLERENONE is used to treat your heart failure to prevent worsening and reduce hospitalisations if you have: 1. had a recent heart attack, in combination with other drugs that are used to treat your heart failure, or 2. have persistent, mild symptoms despite the treatment you have been receiving so far. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPLERENON VIATRIS DO NOT TAKE EPLERENON VIATRIS: − if you are allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6) − if you have high levels of potassium in your blood (hyperkalemia) − if you are taking groups of drugs which help you to excrete excessive body fluid (potassium Lees het volledige document
NLD 24C01 1 NLD 24C01 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Eplerenon Viatris 25 mg, filmomhulde tabletten. Eplerenon Viatris 50 mg, filmomhulde tabletten. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg of eplerenone. Each tablet contains 50 mg of eplerenone. Excipient(s) with known effect Each 25 mg tablet contains 33.9 mg of lactose equivalent to 35.7 mg of lactose monohydrate (see section 4.4). Each 50 mg tablet contains 67.8 mg of lactose equivalent to 71.4 mg of lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). _25 mg: _Yellow, debossed, arc-diamond shaped, film-coated tablet with ‘VLE’ on one side of tablet, ‘NSR’ over ‘25’ on other side of tablet. _50 mg: _Yellow, debossed, arc-diamond shaped, film-coated tablet with ‘VLE’ on one side of tablet, ‘NSR’ over ‘50’ on other side of tablet. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Eplerenone is indicated: • in addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular (CV) mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤ 40 %) and clinical evidence of heart failure after recent myocardial infarction (MI). • in addition to standard optimal therapy, to reduce the risk of CV mortality and morbidity in adult patients with New York Heart Association (NYHA) class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30%) (see section 5.1). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ For the individual adjustment of dose, the strengths of 25 mg and 50 mg are available. The maximum dose regimen is 50 mg daily. _ _ NLD 24A08 2 _For post-MI heart failure patients_ The recommended maintenance dose of eplerenone is 50 mg once daily (OD). Treatment should be initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks, taking into account the s Lees het volledige document