EPLERENONE MEVON FILM-COATED TABLETS 50 MG

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Eplerenone

Saatavilla:

NOVEM PHARMA PRIVATE LIMITED

ATC-koodi:

C03DA04

Lääkemuoto:

TABLET, FILM COATED

Koostumus:

Eplerenone 50.000 mg

Antoreitti:

ORAL

Prescription tyyppi:

Prescription Only

Valmistaja:

Pharmathen S.A.

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2024-02-06

Valmisteyhteenveto

1
1. NAME OF THE MEDICINAL PRODUCT
Eplerenone MEVON 25 mg film-coated tablets
Eplerenone MEVON 50 mg film-coated tablets
2. 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 and 0.018
mmol (0.41 mg) of
sodium (see section 4.4).
Each 50 mg tablet contains 71.4 mg of lactose monohydrate and 0.035
mmol (0.81 mg) of
sodium (see section 4.4).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
25 mg tablet: yellow, round biconvex tablets, 6.1mm in diameter and
2.6mm in
thickness
engraved with “E25” on one side
50 mg tablet: yellow, round biconvex tablets, 8.1mm in diameter and
3.3mm in
thickness
engraved with “E50” on one side
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERTENSION
Eplerenone is indicated for the treatment of hypertension. In these
patients, eplerenone may
be used alone or in combination with other antihypertensive agents.
HEART FAILURE - POST-MYOCARDIAL INFARCTION (MI)
Eplerenone is indicated, in addition to standard therapy, to reduce
the risk of cardiovascular
mortality and cardiovascular hospitalization in stable patients with
left ventricular dysfunction
(left ventricular ejection fraction [LVEF]
≤
40%) and clinical evidence of heart failure after
recent MI.
NEW YORK HEART ASSOCIATION (NYHA) CLASS II (CHRONIC) HEART FAILURE
Eplerenone is indicated, in addition to standard optimal therapy to
reduce the risk of
cardiovascular mortality and hospitalization in heart failure adult
patients with NYHA class II
(chronic) heart failure and left ventricular systolic dysfunction
(LVEF
≤
30% or LVEF
≤
35% in addition to QRS duration of >130 msec) (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For the individual adjustment of dose, the strengths of 25 mg and 50
mg are available.
2
The maximum dose regimen is 50 mg daily for heart failure and 100 mg
daily for
hypertension.
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