Eplerenone Krka 25 mg film-coated tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Eplerenone

זמין מ:

KRKA, d.d., Novo mesto

קוד ATC:

C03DA; C03DA04

INN (שם בינלאומי):

Eplerenone

כמות:

25 milligram(s)

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Aldosterone antagonists; eplerenone

מצב אישור:

Marketed

תאריך אישור:

2018-08-24

עלון מידע

1.3.1
Eplerenone
SPC, Labeling and Package Leaflet
IE
SmPCPIL127376_1
19.02.2019 – Updated: 19.02.2019
Page 1 of 8
PACKAGE LEAFLET
1.3.1
Eplerenone
SPC, Labeling and Package Leaflet
IE
SmPCPIL127376_1
19.02.2019 – Updated: 19.02.2019
Page 2 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPLERENONE KRKA 25 MG FILM-COATED TABLETS
EPLERENONE KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Eplerenone Krka
3.
How to take Eplerenone Krka
4.
Possible side effects
5.
How to store Eplerenone Krka
6.
Contents of the pack and other information
1.
WHAT EPLERENONE KRKA IS AND WHAT IT IS USED FOR
Eplerenone Krka
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 Krka
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 KRKA
DO NOT TAKE EPLERENONE KRKA:
-
if you are allergic to eplerenone or any of the other ingredients o

מאפייני מוצר

Health Products Regulatory Authority
21 August 2019
CRN008Y6L
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eplerenone Krka 25 mg Film-Coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg eplerenone.
Excipient with known effect: lactose monohydrate
Each film-coated tablet contains 34.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (Tablet)
Yellow, round, biconvex, film-coated tablets, marked 25 on one side.
Dimensions: diameter 6 mm.
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 weeks; taking into
account the serum potassium level (see T