Eplerenone 25 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Eplerenone

Available from:

Morningside Healthcare (Malta) Limited

ATC code:

C03DA; C03DA04

INN (International Name):

Eplerenone

Dosage:

25 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Aldosterone antagonists; eplerenone

Authorization status:

Not marketed

Authorization date:

2013-04-05

Summary of Product characteristics

Health Products Regulatory Authority
18 December 2020
CRN00C254
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eplerenone 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 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.
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).
Patients with a serum potassium of > 5,0 mmol/l should not be started
on eplerenone