Eplerenone Mylan 50 mg film-coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Eplerenone

Boleh didapati daripada:

McDermott Laboratories Ltd t/a Gerard Laboratories

Kod ATC:

C03DA; C03DA04

INN (Nama Antarabangsa):

Eplerenone

Dos:

50 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Aldosterone antagonists; eplerenone

Status kebenaran:

Not marketed

Tarikh kebenaran:

2013-11-08

Risalah maklumat

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28 Apr 2015
1/2
11:52
Eplerenone 25/50 mg All
Leaflet
626512
349889
626512
N/A
Unichem Labs
N/A
1
Black
Times
10 pt
10 pt
TBC
N/A
253148
1
Ireland
N/A
N/A
170 x 600mm
626512
1.
WHAT EPLERENONE MYLAN IS AND WHAT IT
IS USED FOR
Eplerenone Mylan 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 Mylan 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 EPLERENONE MYLAN
DO NOT TAKE EPLERENONE MYLAN:
•
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
•
if you have severe liver disease
•
if you are taking medicines that are used
to treat fungal infection (ketoconazole or
itraconazole)
•
if you are taking antiviral medication for
treating HIV (nelfinavir or ritonavir)
•
if you are taking antibiotics used to treat
bacterial infections (clarithromycin or
telithromycin)
•
if

Ciri produk

Health Products Regulatory Authority
19 October 2018
CRN008L6P
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eplerenone Mylan 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg eplerenone.
Excipient with known effect:
Each 50 mg tablet contains 71.04 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Eplerenone Mylan 50 mg film-coated tablets are yellow, film-coated,
round, biconvex
tablets, marked with ‘EP2’ on one side and ‘M’ on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eplerenone is indicated

in addition to standard therapy including beta-blockers, to reduce the
risk
of cardiovascular mortality and morbidity in stable patients with left
ventricular dysfunction (LVEF ≤ 40 %) and clinical evidence of heart
failure
after recent myocardial infarction.

in addition to standard optimal therapy, to reduce the risk of
cardiovascular mortality and morbidity in adult patients with 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.
_For post-myocardial infarction heart failure patients_
Health Products Regulatory Authority
19 October 2018
CRN008L6P
Page 2 of 16
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 myocardial infarction.
_For patients with NYHA class II (chronic) heart failure_
For chronic heart failure NYHA class II patients, treatment should be
initiated at a
dose of 25 mg once daily and titrated