Eplerenon Viatris 25 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

EPLERENON 25 mg/stuk

Beschikbaar vanaf:

Pfizer B.V. Rivium Westlaan 142 2909 LD CAPELLE A/D IJSSEL

ATC-code:

C03DA04

INN (Algemene Internationale Benaming):

EPLERENON 25 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Eplerenone

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

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NLD 24C01
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPLERENON VIATRIS 25 MG, FILMOMHULDE TABLETTEN
EPLERENON VIATRIS 50 MG, FILMOMHULDE TABLETTEN
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 EPLERENON VIATRIS is and what it is used for
2.
What do you need to know before you take EPLERENON VIATRIS
3.
How to take EPLERENON VIATRIS
4.
Possible side effects
5.
How to store EPLERENON VIATRIS
6.
Contents of the pack and other information
1.
WHAT EPLERENON VIATRIS IS AND WHAT IT IS USED FOR
EPLERENONE 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 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 EPLERENON VIATRIS
DO NOT TAKE EPLERENON VIATRIS:
−
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

Productkenmerken

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NLD 24C01
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Eplerenon Viatris 25 mg, filmomhulde tabletten.
Eplerenon Viatris 50 mg, filmomhulde tabletten.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of eplerenone.
Each tablet contains 50 mg of eplerenone.
Excipient(s) 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).
Each 50 mg tablet contains 67.8 mg of lactose equivalent to 71.4 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: _Yellow, debossed, arc-diamond shaped, film-coated tablet with
‘VLE’ on one side of tablet,
‘NSR’ over ‘25’ on other side of tablet.
_50 mg: _Yellow, debossed, arc-diamond shaped, film-coated tablet with
‘VLE’ on one side of tablet,
‘NSR’ over ‘50’ on 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.
_ _
NLD 24A08
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_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 s