Eplerenone Accord 25 mg film-coated tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Eplerenone

Saadav alates:

Accord Healthcare Ireland Ltd.

ATC kood:

C03DA; C03DA04

INN (Rahvusvaheline Nimetus):

Eplerenone

Annus:

25 milligram(s)

Ravimvorm:

Film-coated tablet

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Aldosterone antagonists; eplerenone

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2013-08-09

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPLERENONE ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Eplerenone Accord
3.
How to take Eplerenone Accord
4.
Possible side effects
5.
How to store Eplerenone Accord
6.
Contents of the pack and other information
1.
WHAT EPLERENONE ACCORD 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 hospitalisations if you have:
-
had a recent 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 ACCORD
DO NOT TAKE EPLERENONE ACCORD

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, (potassium sparing
diuretics) or “SALT TABLETS” (potassium supplements).

if

Toote omadused

Health Products Regulatory Authority
07 January 2020
CRN009GWY
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eplerenone Accord 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