INSPRA 25 mg film-coated tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Eplerenone

MAH:

Pfizer Healthcare Ireland

ATC_code:

C03DA; C03DA04

INN:

Eplerenone

dosage:

25 milligram(s)

pharmaceutical_form:

Film-coated tablet

prescription_type:

Product subject to prescription which may be renewed (B)

therapeutic_area:

Aldosterone antagonists; eplerenone

authorization_status:

Marketed

authorization_date:

2004-08-20

PIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
INSPRA
® 25 MG FILM-COATED TABLETS
INSPRA® 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
INSPRA
is and what it is used for
2.
What you need to know before
you take
INSPRA
3.
How to take
INSPRA
4.
Possible side effects
5.
How to store
INSPRA
6.
Contents of the pack and other information
1.
WHAT INSPRA IS AND WHAT IT IS USED FOR
INSPRA
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.
INSPRA
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 B
EFORE YOU TAKE INSPRA
DO NOT TAKE INSPRA

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 (hyperkalemia)
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2020-0061520 & 2018-0039847

if you are taking groups of drugs which help you to excrete excessive
body fluid
(potassium sparing diuretics)

if you have severe kidney dis

SPC

Health Products Regulatory Authority
22 April 2021
CRN009Y2R
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
INSPRA 25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of eplerenone.
Excipients with known effect
Each 25 mg tablet contains 33.9 mg of lactose equivalent to 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 (tablet).
25 mg tablet: yellow tablet with stylized "Pfizer" on one side of
tablet, "NSR" over "25"on the other side of tablet.
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