Eplerenone 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Eplerenone

Available from:

Zentiva Pharma UK Ltd

ATC code:

C03DA04

INN (International Name):

Eplerenone

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020300; GTIN: 5000283657408

Patient Information leaflet

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 is and what it is used for
2. What 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:
−
had a recent heart attack, in combination
with other drugs that are used to treat
your heart failure, or
−
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 live

Summary of Product characteristics

OBJECT 1
EPLERENONE 25 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 08-Nov-2017 | Zentiva
1. Name of the medicinal product
Eplerenone 25 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 25 mg eplerenone.
Excipient with known effect:
Each tablet contains 34.5 mg lactose 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 coloured, round, biconvex film-coated tablets
with a diameter approximately 6 mm
and thickness approximately 3.0 mm.
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