EPLERENONE ACTAVIS 25 Milligram Film Coated Tablet

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

EPLERENONE

Fáanlegur frá:

Actavis Group PTC ehf

ATC númer:

C03DA04

INN (Alþjóðlegt nafn):

EPLERENONE

Skammtar:

25 Milligram

Lyfjaform:

Film Coated Tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Aldosterone antagonists

Leyfisstaða:

Authorised

Leyfisdagur:

2013-08-09

Upplýsingar fylgiseðill

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EPLERENONE 25 MG & 50 MG TABLETS PIL - IRELAND
Black
BBBA0526
S.Anson
16.02.17
09.03.17
S.Anson
160 x 330
9pts
Synthon ES
16.02.17
20.02.17
4
EPLERENONE ACTAVIS 25 MG 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 IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
EPLERENONE ACTAVIS
3
HOW TO TAKE EPLERENONE ACTAVIS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE EPLERENONE ACTAVIS
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT EPLERENONE ACTAVIS IS 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 hospitalisation if you have:
1. had a recent heart attack, in combination with other d

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eplerenone Actavis 25 mg, film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of eplerenone.
Excipient with known effect:
Each 25 mg tablet contains 35.7 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, with a
diameter of about 6 mm. The tablets are debossed
with ‘E9RN’ on one side and ‘25’ 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 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-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 into
account the seru