Inspra 25 mg film-coated tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Eplerenone

MAH:

Imbat Limited

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:

Authorised

authorization_date:

2009-11-06

PIL

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
INSPRA
® 25MG FILM-COATED TABLETS
(eplerenone)
Your medicine is available using the above name but will be
referred to as INSPRA throughout this leaflet.
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)

if you have severe kidney

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Inspra 25mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg eplerenone.
Excipient(s): lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Poland_
Yellow tablet with stylized “Pfizer” on one side of the tablet,
“NSR” over “25” on the other side of the tablet.
_Product imported from Spain:_
Yellow tablet marked with 'NSR'
over '25'
on one side of the tablet and plain on the reverse.
4 CLINICAL PARTICULARS
As per PA0822/020/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/020/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet Core
Lactose monohydrate
Microcrystalline cellulose (E460)
Croscarmellose sodium (E468)
Hypromellose (E464)
Sodium laurilsulfate
Talc (E553b)
Magnesium stearate (E470b)
Tablet coating
_Opadry yellow:_
Hypromellose (E464)
Titanium dioxide (E171)
Macrogol 400
Polysorbate 80 (E433)
Iron oxide yellow (E172)
Iron oxide red (E172)
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6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strips and outer carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medic