EPLERENONE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

EPLERENONE

Available from:

Accord Healthcare Limited

ATC code:

C03DA04

INN (International Name):

EPLERENONE

Dosage:

25 Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

oral use

Units in package:

blisters containing 10 x 1, 28 x 1, 30 x 1, 90 x 1 or 100 x 1 tablets.

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Accord Healthcare Limited

Therapeutic group:

aldosterone antagonists

Therapeutic area:

eplerenone

Therapeutic indications:

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 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%)

Authorization status:

Marketed

Authorization date:

2015-10-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPLERENONE 25 MG FILM-COATED TABLETS
EPLERENONE 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 side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Eplerenone tablet is and what is it 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 IS AND WHAT IS IT USED FOR
Eplerenone tablet 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 tablet 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 TABLETS
DO NOT TAKE EPLERENONE 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 (hyperkalemia)
-
if you are taking groups of drugs which help you to excrete excessive
body fluid, (potassium
sparing diuretics) or “salt tablet

Summary of Product characteristics

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 25mg tablet contains 19 mg of lactose monohydrate (see section
4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow diamond shaped biconvex film-coated tablets, debossed with
“E1” on one side and plain on other side. Length,
width and thickness of the film-coated tablet is 7.20 ±0.3 mm, 6.40
±0.3 mm and 3.15 ±0.3 mm respectively.
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
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-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 in