Inspra 50 mg film-coated tablets

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Eplerenone

Доступно од:

Imbat Limited

АТЦ код:

C03DA; C03DA04

INN (Међународно име):

Eplerenone

Дозирање:

50 milligram(s)

Фармацеутски облик:

Film-coated tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Aldosterone antagonists; eplerenone

Статус ауторизације:

Authorised

Датум одобрења:

2013-09-13

Информативни летак

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
INSPRA
® 50MG 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

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Inspra 50mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50mg of eplerenone.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Spain:_
Yellow, film-coated tablet,
marked with 'NSR'
over '50'
on one side of the tablet and plain on the reverse.
4 CLINICAL PARTICULARS
As per PA0822/020/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/020/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet Core
Lactose monohydrate
Microcrystalline cellulose (E460)
Croscarmellose sodium (E468)
Hypromellose (E464)
Sodium lauryl sulphate
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)
6.2 INCOMPATIBILITIES
Not applicable.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_1_
_/_
_0_
_6_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_2_
_1_
_6_
_1_
_9_
_3_
_0_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
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
No special precautions for storage.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips.
Pa