IDAPREX 8 perindopril erbumine 8mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

perindopril erbumine, Quantity: 8 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: hydrophobic colloidal silica anhydrous; lactose monohydrate; chlorophyllin-copper complex; magnesium stearate; microcrystalline cellulose

Administration route:

Oral

Units in package:

10 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The treatment of hypertension; and the treatment of heart failure. In such patients it is recommended that IDAPREX be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of IDAPREX has not been demonstrated for New York Heart Association Category IV patients); and patients with established coronary artery disease (See Clinical Trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

Product summary:

Visual Identification: Green, round, biconvex, uncoated tablets engraved with an open heart symbol on one face and the Servier logo on the other face.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2003-11-11

Patient Information leaflet

IDAPREX (PERINDOPRIL ERBUMINE)
1
IDAPREX® 2
IDAPREX® 4
IDAPREX® 8
_perindopril (pronounced per-in-do-pril) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about IDAPREX. It does
not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or nurse. If you get any
side effects, talk to your doctor,
pharmacist or nurse. This includes
any possible side effects not listed in
this leaflet.
All medicines have risks and
benefits. Your doctor has weighed
the risks of taking IDAPREX against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, PHARMACIST OR NURSE. KEEP
THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IDAPREX IS
The name of your medicine is
IDAPREX. The medicine contains
the active ingredient perindopril
erbumine. Perindopril belongs to a
group of medicines called
angiotensin converting enzyme
(ACE) inhibitors.
WHAT IDAPREX IS
USED FOR
IDAPREX is available only with a
doctor's prescription.
IDAPREX lowers high blood
pressure, a condition which doctors
call hypertension.
Everyone has blood pressure. This
pressure helps get your blood all
around the body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. You have
high blood pressure when your blood
pressure stays higher than is needed,
even when you are calm or relaxed.
There are usually no symptoms of
high blood pressure. The only way of
knowing that you have it is to have
your blood pressure checked on a
regular basis. If high blood pressure
is not treated it can lead to serious
health problems. You may feel fine
and have no symptoms, but
eventually it can cause stroke, heart
disease and kidney failure.
IDAPREX helps lower your blood
pressure.
You may be prescribed IDAPREX
for heart failure. Heart failure means
that the heart muscle cannot pump
blood strongly enough to supply all
the blood needed throughout the
body.

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - IDAPREX (PERINDOPRIL ERBUMINE)
Version: 17
1/24
AUSTRALIAN PRODUCT INFORMATION
IDAPREX (PERINDOPRIL ERBUMINE) UNCOATED TABLETS
1
NAME OF THE MEDICINE
Perindopril erbumine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each IDAPREX 2 tablet contains 2 mg of perindopril erbumine. Each
IDAPREX 4 tablet contains 4 mg of
perindopril erbumine. Each IDAPREX 8 tablet contains 8 mg of
perindopril erbumine.
Excipient with known effect: contains sugars as lactose. For the full
list of excipients, _see section 6.1 - List of _
_excipients_.
3
PHARMACEUTICAL FORM
IDAPREX 2: Round biconvex white uncoated tablets. IDAPREX 4:
Rod-shaped biconvex scored white
uncoated tablets. IDAPREX 8: Round biconvex green uncoated tablets
with a Servier logo on one face and a
heart logo on the other face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
IDAPREX is indicated for:
•
the treatment of hypertension;
•
the treatment of heart failure. In such patients it is recommended
that IDAPREX be given with a diuretic
and/or digoxin under close medical supervision. (The safety and
efficacy of IDAPREX has not been
demonstrated for New York Heart Association Category IV patients); and
•
patients with established coronary artery disease (_see section 5.1 -
Pharmacodynamic properties_) who
are stable on concomitant therapy and have no heart failure to reduce
the risk of non-fatal myocardial
infarction or cardiac arrest.
4.2
D
OSE AND METHOD OF ADMINISTRATION
HYPERTENSION
The usual starting dose is one IDAPREX 4 (4 mg) tablet once daily,
taken in the morning. Optimum control
of blood pressure is achieved by increasing the dose, titrating it
against the blood pressure to a maximum
of one IDAPREX 8 (8 mg) tablet once daily.
A starting dose of one IDAPREX 2 (2 mg) tablet once daily is
recommended in the following patients who
may be at risk of ACE inhibitor-induced hypotension:
•
_Combination with a Diuretic _
The administration of IDAPREX to patients under current treatment with
a diuretic may induce
hypotension a