Inspra 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Eplerenone

Available from:

Waymade Healthcare Plc

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

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
INSPRA
® 25 MG AND 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 INSPRA is and what it is used for
2.
What you need to know before you take INSPRA
3.
How to take INSPRA
4.
Possible side effects
5.
How to store INSPRA
6.
Contents of the pack and other information
1. WHAT INSPRA IS AND WHAT IT IS USED FOR
INSPRA 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.
INSPRA 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 INSPRA
DO NOT TAKE INSPRA
-
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 disease
-
if you are taking medicines that are used to treat fungal infection
(ket

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
INSPRA 50 mg film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of eplerenone.
Excipients 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 tablet: yellow tablet with stylised “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
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 m