Eplerenone 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Eplerenone

Available from:

Upjohn UK Ltd

ATC code:

C03DA04

INN (International Name):

Eplerenone

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020300; GTIN: 5013457010978

Patient Information leaflet

Page 1 of 8
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 B
EFORE 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)
Page 2 of 8

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

Summary of Product characteristics

OBJECT 1
EPLERENONE 50MG FILM COATED TABLETS
Summary of Product Characteristics Updated 17-May-2017 | Pfizer
Limited
1. Name of the medicinal product
Eplerenone 50 mg film-coated tablets.
2. Qualitative and quantitative composition
Each tablet contains 50 mg of eplerenone.
Excipient(s) with known effect
Each 50 mg 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.
_50 mg_ : Yellow, debossed, arc-diamond shaped, film-coated tablet
with stylized “Pfizer” on one side of
tablet, “NSR” over “50”on the other side of tablet.
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 acute MI.
_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 preferabl