País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Eplerenone
Morningside Healthcare Ltd
C03DA; C03DA04
Eplerenone
25 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Aldosterone antagonists; eplerenone
Not marketed
2013-04-05
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, pharmacist or nurse. ! 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET 1. What Eplerenone Tablets are and what they are used for 2. What you need to know before you take Eplerenone Tablets 3. How to take Eplerenone Tablets 4. Possible side effects 5. How to store Eplerenone Tablets 6. Contents of the pack and other information 1. WHAT EPLERENONE TABLETS ARE AND WHAT THEY ARE USED FOR Eplerenone Tablets belong to a group of medicines called selective aldosterone antagonists. These antagonists inhibit the action of aldosterone, a substance produced within the body which helps to control your blood pressure and heart function. High levels of aldosterone can cause changes in your body that lead to heart failure. Eplerenone Tablets can help prevent worsening heart failure after a heart attack, in combination with other drugs that are used to treat your heart failure or have persistent, mild symptoms despite the treatment you have been receiving so far. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPLERENONE TABLETS DO NOT TAKE EPLERENONE TABLETS ! if you are allergic to Eplerenone Tablets 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 medicines which help you to excrete excessive body fluid, such as potassium sparing diuretics or potassium supplements ! if you have severe kidney disease ! if you have severe liver disease ! if you are taking medicines that are used to treat fungal infection (ketoconazole or it Leer el documento completo
Health Products Regulatory Authority 04 February 2019 CRN008NNP Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eplerenone 25mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg of eplerenone. Excipients with known effect: Each 25 mg tablet contains 36.625 mg of lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Round, yellow and convex film-coated tablets. 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 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. 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 four 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. Health Products Regulatory Authority 04 February 2019 CRN008NNP Page 2 of 15 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 serum potassium level (see Table 1 and section 4.4). Patient Leer el documento completo