Eplerenone Rowex 50 mg film-coated tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Eplerenone

Saadav alates:

Rowex Ltd

ATC kood:

C03DA; C03DA04

INN (Rahvusvaheline Nimetus):

Eplerenone

Annus:

50 milligram(s)

Ravimvorm:

Film-coated tablet

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Aldosterone antagonists; eplerenone

Volitamisolek:

Marketed

Loa andmise kuupäev:

2011-11-25

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPLERENONE ROWEX 25 MG FILM-COATED TABLETS
EPLERENONE ROWEX 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 Rowex is and what it is used for
2.
What you need to know before you take Eplerenone Rowex
3.
How to take Eplerenone Rowex
4.
Possible side effects
5.
How to store Eplerenone Rowex
6.
Contents of the pack and other information
1.
WHAT EPLERENONE ROWEX IS AND WHAT IT IS USED FOR
Eplerenone Rowex contains the active substance eplerenone. 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 medicines 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 ROWEX
DO NOT TAKE EPLERENONE ROWEX:

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 MEDICINES WHICH HELP YOU TO EXCRETE
EX

Toote omadused

Health Products Regulatory Authority
21 February 2023
CRN00D5WR
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eplerenone Rowex 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of eplerenone.
Excipient with known effect
Each film-coated tablet contains 67.8 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Light yellow, round, biconvex film-coated tablet, with a diameter of
about 8 mm. The tablet is 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 (CV) mortality and
morbidity in stable patients with left ventricular dysfunction (LVEF
≤40 %) and clinical evidence of heart failure
after recent myocardial infarction (MI).

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. The maximum dose regimen is 50 mg
daily.
_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 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 MI.
_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