Inspra 50mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

EPLERENONE

Available from:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC code:

C03DA04

INN (International Name):

EPLERENONE 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

EPLERENONE 50 mg

Prescription type:

POM

Therapeutic area:

DIURETICS

Authorization status:

Withdrawn

Authorization date:

2008-09-12

Patient Information leaflet

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PACKAGE LEAFLET
PAGE 2 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
INSPRA 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 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 BEFORE 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)

if you are taking groups of drugs which help you to excrete excessive
body fluid, (potassium
sparing diuretics) or “salt tablets” (potassium supplements)

if you have severe kidney disease
PAGE 3 OF 8

i

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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NAME OF THE MEDICINAL PRODUCT
INSPRA 25 mg film-coated tablets.
INSPRA 50 mg film-coated tablets.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of eplerenone.
Each tablet contains 50 mg of eplerenone.
Excipients with known effect:
Each 25 mg tablet contains 35.7 mg of lactose monohydrate (see section
4.4).
Each 50 mg tablet contains 71.4 mg of lactose monohydrate (see section
4.4).
For the full list of excipients see section 6.1.
PHARMACEUTICAL FORM
Film-coated tablet.
25 mg tablet: yellow tablet with stylized “Pfizer” on one side of
tablet, “NSR” over “25”on the
other side of tablet.
50 mg tablet: yellow tablet with stylized “Pfizer” on one side of
tablet, “NSR” over “50”on the
other side of tablet.
CLINICAL PARTICULARS
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).
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_
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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