Eplerenone Mylan 25 mg film-coated tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Eplerenone

Доступна з:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Код атс:

C03DA; C03DA04

ІПН (Міжнародна Ім'я):

Eplerenone

Дозування:

25 milligram(s)

Фармацевтична форма:

Film-coated tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Aldosterone antagonists; eplerenone

Статус Авторизація:

Marketed

Дата Авторизація:

2013-11-08

інформаційний буклет

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPLERENONE MYLAN 25 MG FILM-COATED TABLETS
EPLERENONE MYLAN 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 Eplerenone Mylan is and what it is used for
2.
What you need to know before you take Eplerenone Mylan
3.
How to take Eplerenone Mylan
4.
Possible side effects
5.
How to store Eplerenone Mylan
6.
Contents of the pack and other information
1.
WHAT EPLERENONE MYLAN IS AND WHAT IT IS USED FOR
Eplerenone Mylan 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 Mylan
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 MYLAN
DO NOT TAKE EPLERENONE MYLAN:
-
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)

Характеристики продукта

Health Products Regulatory Authority
20 December 2022
CRN00D653
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eplerenone Mylan 25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg eplerenone.
Excipient with known effect:
Each 25 mg tablet contains 35.52 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Eplerenone Mylan 25 mg film-coated tablets are yellow, film-coated,
round, biconvex tablets, marked with ‘EP1’ on one side
and ‘M’ on other side.
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
cardiovascular mortality and morbidity in adult
patients with 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-myocardial infarction 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 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 i