国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Eplerenone
Pfizer Healthcare Ireland
C03DA; C03DA04
Eplerenone
25 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Aldosterone antagonists; eplerenone
Marketed
2004-08-20
Page 1 of 8 2020-0061520 & 2018-0039847 PACKAGE LEAFLET: INFORMATION FOR THE USER INSPRA ® 25 MG FILM-COATED TABLETS INSPRA® 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 INSPRA is and what it is used for 2. What you need to know before you take INSPRA 3. How to take INSPRA 4. Possible side effects 5. How to store INSPRA 6. Contents of the pack and other information 1. WHAT INSPRA IS AND WHAT IT IS USED FOR INSPRA 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. INSPRA 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 B EFORE YOU TAKE INSPRA DO NOT TAKE INSPRA 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) Page 2 of 8 2020-0061520 & 2018-0039847 if you are taking groups of drugs which help you to excrete excessive body fluid (potassium sparing diuretics) if you have severe kidney dis 完全なドキュメントを読む
Health Products Regulatory Authority 22 April 2021 CRN009Y2R Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT INSPRA 25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg of eplerenone. Excipients 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). For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). 25 mg tablet: yellow tablet with stylized "Pfizer" on one side of tablet, "NSR" over "25"on the 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. _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 serum potassium level (see Table 1). Eplerenone therapy should usually be started within 3-14 days after an acute MI. _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 完全なドキュメントを読む