Eplerenone 50 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Eplerenone

Available from:

Morningside Healthcare Ltd

ATC code:

C03DA; C03DA04

INN (International Name):

Eplerenone

Dosage:

50 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Aldosterone antagonists; eplerenone

Authorization status:

Not marketed

Authorization date:

2013-04-05

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
04 February 2019
CRN008NNP
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eplerenone 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of eplerenone.
Excipients with known effect:
Each 50 mg tablet contains 73.25 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