Nonpres tablets film-coated

Country: Armenia

Bahasa: Inggeris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

eplerenone

Boleh didapati daripada:

Adamed Pharma S.A.

Kod ATC:

C03DA04

INN (Nama Antarabangsa):

eplerenone

Dos:

50mg

Borang farmaseutikal:

tablets film-coated

Unit dalam pakej:

(20/2x10/) in blister, (30/3x10/) in blister

Jenis preskripsi:

Prescription

Status kebenaran:

Registered

Tarikh kebenaran:

2020-12-16

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
NONPRES, 25 MG FILM-COATED TABLETS
NONPRES, 50 MG FILM-COATED TABLETS
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 Nonpres is and what it is used for
2.
What you need to know before you take Nonpres
3.
How to take Nonpres
4.
Possible side effects
5.
How to store Nonpres
6.
Contents of the pack and other information
1.
WHAT NONPRES IS AND WHAT IT IS USED FOR
Nonpres 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.
Nonpres 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 NONPRES
DO NOT TAKE NONPRES
•
if you are allergic to eplerenone or to any 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

Ciri produk

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Nonpres, 25 mg film-coated tablets
Nonpres, 50 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg of eplerenone.
Excipient with known effect: each 25 mg film-coated tablet contains
35.7 mg of lactose
monohydrate (see section 4.4).
Each film-coated tablet contains 50 mg of eplerenone.
Excipient with known effect: each 50 mg film-coated tablet contains
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.
Nonpres, 25 mg film-coated tablets are beige, round, biconvex,
debossed "25" on one side.
Nonpres, 50 mg film-coated tablets are beige, round, biconvex,
debossed "50" on one 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.
Page 2 of 14
_ _
_ _
_For post-myocardial infarction 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 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 (c