البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
EPLERENONE
Actavis Group PTC ehf
C03DA04
EPLERENONE
50 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Aldosterone antagonists
Authorised
2013-08-09
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@Actavis.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item no: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. EPLERENONE 25 MG & 50 MG TABLETS PIL - IRELAND Black BBBA0526 S.Anson 16.02.17 09.03.17 S.Anson 160 x 330 9pts Synthon ES 16.02.17 20.02.17 4 EPLERENONE ACTAVIS 25 MG 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 IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPLERENONE ACTAVIS 3 HOW TO TAKE EPLERENONE ACTAVIS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE EPLERENONE ACTAVIS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT EPLERENONE ACTAVIS 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 hospitalisation if you have: 1. had a recent heart attack, in combination with other d اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eplerenone Actavis 50 mg, film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of eplerenone. Excipient with known effect: 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. 50 mg tablet: light yellow, round, biconvex film-coated tablet, with a diameter of about 8 mm. The tablets are 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 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. _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 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 NYHA class II (chronic) heart failure:_ For chronic heart failure NYHA class II patients, treatment should be initiated at a dose of 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks; taking into account the ser اقرأ الوثيقة كاملة