Eplerenone Actavis Tablet, film coated 50mg

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

EPLERENONE

Disponible des:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Codi ATC:

C03DA04

Designació comuna internacional (DCI):

EPLERENONE 50 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

EPLERENONE 50 mg

tipo de receta:

POM

Área terapéutica:

DIURETICS

Estat d'Autorització:

Withdrawn

Data d'autorització:

2016-02-17

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPLERENONE ACTAVIS 25 AND 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 Actavis tablets are and what it is used for
2.
What you need to know before you take Eplerenone Actavis tablets
3.
How to take Eplerenone Actavis tablets
4.
Possible side effects
5.
How to store Eplerenone Actavis tablets
6.
Contents of the pack and other information
1.
WHAT EPLERENONE ACTAVIS TABLETS ARE AND WHAT IT IS USED FOR
Eplerenone 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 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 ACTAVIS TABLETS
DO NOT TAKE EPLERENONE ACTAVIS 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 (hyperkalaemia).

if you are taking GROUPS OF DRUGS WHICH HELP YOU TO EXCRETE EXCESSIVE
BODY FLUID, (potassi

Fitxa tècnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Eplerenone Actavis 25 mg, film-coated tablets
Eplerenone Actavis 50 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of eplerenone.
Each tablet contains 50 mg of eplerenone.
Excipient with known effect:
Each 25 mg tablet contains 35.7 mg of lactose monohydrate (see section
4.4).
Each 50 mg tablet contains 71.4 mg of lactose monohydrate (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
25 mg tablet: light yellow, round, biconvex film-coated tablet,
debossed with ‘E9RN’ on one side and ‘25’
on the other side.
50 mg tablet: light yellow, round, biconvex film-coated tablet,
debossed with ‘E9RN’ on one side and ‘50’
on the 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
2
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 NY