Eplerenone 25mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Eplerenone

Disponibil de la:

Teva UK Ltd

Codul ATC:

C03DA04

INN (nume internaţional):

Eplerenone

Dozare:

25mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 02020300; GTIN: 5017007018834

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 is and what it is used for
2. What do you need to know before you take
EPLERENONE
3. How to take EPLERENONE
4. Possible side effects
5. How to store EPLERENONE
6. Contents of the pack and other information
1.
WHAT EPLERENONE 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
EPLERENONE
DO NOT TAKE EPLERENONE
–
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 have severe kidney disease
–
if you have severe liver

Caracteristicilor produsului

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