ESPLER eplerenone 25 mg tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

eplerenone, Quantity: 25 mg

Tilgængelig fra:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Eplerenone

Lægemiddelform:

Tablet, film coated

Sammensætning:

Excipient Ingredients: lactose monohydrate; sodium lauryl sulfate; hypromellose; magnesium stearate; macrogol 400; titanium dioxide; microcrystalline cellulose; polysorbate 80; iron oxide red; iron oxide yellow; purified talc; croscarmellose sodium

Indgivelsesvej:

Oral

Enheder i pakken:

120, 90, 20, 30, 60

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Eplerenone is indicated: - to reduce the risk of cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3-14 days of an acute myocardial infarction (see CLINICAL TRIALS and DOSAGE AND ADMINISTRATION). ; - 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 less than or equal to 30% or LVEF less than or equal to 35% in addition to QRS duration of greater than 130 msec), in addition to standard optimal therapy (see CLINICAL TRIALS).

Produkt oversigt:

Visual Identification: Beige, round, biconvex tablets, debossed '25' on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Licence status A

Autorisation dato:

2015-10-21

Indlægsseddel

1
ESPLER
_Eplerenone _
_ _
_ _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ESPLER.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ESPLER
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ESPLER IS USED
FOR
_WHAT ESPLER DOES_
•
THIS MEDICINE IS USED TO TREAT
HEART FAILURE IN PATIENTS WHO
HAVE EXPERIENCED A HEART
ATTACK.
A heart attack occurs when one of
the major blood vessels supplying
blood to your heart becomes blocked.
This means that your heart cannot
receive the oxygen it needs and
becomes damaged. This may lead to
further problems, such as heart
failure, irregular heart rhythms and
blood clots.
Heart failure means that the heart
muscle is weak and cannot pump
blood strongly enough to supply all
the blood needed throughout the
body. Heart failure is not the same as
heart attack, and may start off with
mild or no symptoms, but as the
condition progresses, patients may
feel short of breath or may get tired
easily after light physical activity
such as walking. Some patients may
wake up short of breath at night, or
have to prop their heads up during
sleep to avoid this problem. Fluid
may collect in different parts of the
body, often first noticed as swollen
ankles and feet.
•
THIS MEDICINE IS ALSO USED TO
REDUCE THE RISK OF DEATH OR NEED
FOR HOSPITALISATIONS DUE TO HEART
FAILURE IN PATIENTS WITH CHRONIC
HEART FAILURE.
_HOW ESPLER WORKS _
Your body makes a substance called
aldosterone. It is important for
regulating blood pressure and is one
of the factors involved in heart
function. Sometimes aldosterone can
cause changes in our body that lead
to heart failure. ESPLER works by
blocking the action of aldosterone,
and slowing the progr

Produktets egenskaber

1
AUSTRALIAN PRODUCT INFORMATION –
ESPLER (EPLERENONE) TABLETS
1
NAME OF THE MEDICINE
Eplerenone.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each eplerenone tablet contains 25 or 50 mg eplerenone
Contains lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eplerenone is supplied as film-coated tablets containing 25 or 50 mg
eplerenone.
25 MG TABLET: Beige, round, biconvex tablets, debossed "25" on one
side.
50 MG TABLET: Beige, round, biconvex tablets, debossed "50" on one
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Eplerenone is indicated:
•
to reduce the risk of cardiovascular death in combination with
standard therapy in patients
who have evidence of heart failure and left ventricular impairment
within 3-14 days of an
acute myocardial infarction (see section 5.1 CLINICAL TRIALS and
section 4.2 DOSE AND
METHOD OF ADMINISTRATION).
•
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% or LVEF
≤35% in addition to QRS duration of > 130 msec), in addition to
standard optimal therapy
(see section 5.1 CLINICAL TRIALS).
4.2
D
OSE AND METHOD OF ADMINISTRATION
FOR POST-MYOCARDIAL INFARCTION HEART FAILURE PATIENTS
Eplerenone is usually administered in combination with standard
therapies. The recommended dose
of eplerenone is 50 mg once daily. Treatment should be initiated at 25
mg once daily and titrated to
the target dose of 50 mg once daily within 4 weeks as tolerated by the
patient.
In the pivotal clinical study EPHESUS, eplerenone was added to
standard medical therapy within 3-14
days after an acute qualifying myocardial infarction. There is
evidence that the reduction in mortality
2
occurred mostly within the first 12 months of eplerenone treatment.
Patients with chronic heart
failure should be reassessed no longer than 12 months after commencing
therapy and options for
the management of chronic heart failure considered.
FOR