Eplerenone Bluefish 25 mg film-coated tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Eplerenone

Dostupno od:

Bluefish Pharmaceuticals AB

ATC koda:

C03DA; C03DA04

INN (International ime):

Eplerenone

Doziranje:

25 milligram(s)

Farmaceutski oblik:

Film-coated tablet

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

Aldosterone antagonists; eplerenone

Status autorizacije:

Marketed

Datum autorizacije:

2013-11-29

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPLERENONE BLUEFISH 25 MG FILM-COATED TABLETS
EPLERENONE BLUEFISH 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 or
nurse.
−
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
or nurse. This includes any possible
side effects not listed in this leaflet See section 4.
WHAT IS IN THIS LEAFLET
1. What Eplerenone Bluefish
is and what it is used for
2. What you need to know before you take Eplerenone Bluefish
3. How to take Eplerenone Bluefish
4. Possible side effects
5. How to store Eplerenone Bluefish
6. Contents of the pack and other information
1. WHAT EPLERENONE BLUEFISH IS AND WHAT IT IS USED FOR
Eplerenone Bluefish 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 Bluefish 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 BLUEFISH
DO NOT TAKE EPLERENONE BLUEFISH
•
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 (hyperkalaemia)
2
•
if you are taking groups of medicines which help you to excrete
e

Svojstava lijeka

Health Products Regulatory Authority
11 October 2023
CRN00D0H6
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eplerenone Bluefish 25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of eplerenone.
Each tablet contains 50 mg of eplerenone.
Excipient with known effect:
Each 25mg tablet contains 35.7mg of lactose(as monohydrate) (see
section 4.4).
Each 50mg tablet contains 71.4mg of lactose(as monohydrate) (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, engraved with "E25" on
one side with dimensions of 2.6 ± 0.2 mm thickness and
6.1 ± 0.1mm diameter
50 mg tablet: yellow, round biconvex tablets, engraved with "E50" on
one side with dimensions of 3.3 ± 0.2 mm thickness and
8.1 ± 0.1mm 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 (CV) mortality and
morbidity in stable patients with left ventricular dysfunction (LVEF
40 %) and clinical evidence of heart failure after
recent myocardial infarction (MI).

in addition to standard optimal therapy, to reduce the risk of CV
mortality and morbidity in adult patients with
New York Heart Association (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-MI 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 a