Eplerenone 25mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Eplerenone

Tersedia dari:

Medical Valley Invest AB

Kode ATC:

C03DA04

INN (Nama Internasional):

Eplerenone

Dosis:

25mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 02020300; GTIN: 5060570900341

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
Eplerenone 25 mg
film-coated tablets
Eplerenone 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 Eplerenone tablet is and what it is used for
2. What you need to know before you take
Eplerenone tablets
3. How to take Eplerenone tablets
4. Possible side effects
5. How to store Eplerenone tablets
6. Contents of the pack and other information 1. WHAT EPLERENONE TABLET IS
AND WHAT IT IS USED FOR
Eplerenone tablet 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 tablet 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 TABLETS
DO NOT TAKE EPLERENONE TABLETS
-
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

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Eplerenone 25 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of eplerenone.
Excipients with known effect:
Each 25 mg tablet contains 36,625 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Round, yellow and biconvex film-coated tablets, with approximately 6.0
mm of
diameter.
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: _
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 to the target dose of 50 mg once
daily
preferably within 4 weeks; taking into account the serum potassium
level (see Table 1
and section 4.4).
Patients with a serum potassium of > 5.0 mmol/L should not be st