Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
EPLERENONE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
C03DA04
EPLERENONE 50 mg
FILM-COATED TABLET
EPLERENONE 50 mg
POM
DIURETICS
Withdrawn
2016-02-17
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EPLERENONE ACTAVIS 25 AND 50 MG FILM-COATED TABLETS 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 Eplerenone Actavis tablets are and what it is used for 2. What you need to know before you take Eplerenone Actavis tablets 3. How to take Eplerenone Actavis tablets 4. Possible side effects 5. How to store Eplerenone Actavis tablets 6. Contents of the pack and other information 1. WHAT EPLERENONE ACTAVIS TABLETS ARE 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 EPLERENONE ACTAVIS TABLETS DO NOT TAKE EPLERENONE ACTAVIS TABLETS 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 (hyperkalaemia). if you are taking GROUPS OF DRUGS WHICH HELP YOU TO EXCRETE EXCESSIVE BODY FLUID, (potassi Belgenin tamamını okuyun
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Eplerenone Actavis 25 mg, film-coated tablets Eplerenone Actavis 50 mg, film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg of eplerenone. Each tablet contains 50 mg of eplerenone. Excipient with known effect: Each 25 mg tablet contains 35.7 mg of lactose monohydrate (see section 4.4). Each 50 mg tablet contains 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. 25 mg tablet: light yellow, round, biconvex film-coated tablet, debossed with ‘E9RN’ on one side and ‘25’ on the other side. 50 mg tablet: light yellow, round, biconvex film-coated tablet, debossed with ‘E9RN’ on one side and ‘50’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eplerenone is indicated: in addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤ 40 %) and clinical evidence of heart failure after recent myocardial infarction. in addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult patients with 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. _ _ _For post-myocardial infarction 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 2 account the serum potassium level (see Table 1). Eplerenone therapy should usually be started within 3- 14 days after an acute myocardial infarction. _ _ _For patients with NY Belgenin tamamını okuyun