PERINDOPRIL AN perindopril erbumine 2mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
30-06-2020
Summary of Product characteristics
(SPC)
30-06-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
perindopril erbumine
Available from:
Servier Laboratories Australia Pty Ltd
INN (International Name):
Perindopril erbumine
Authorization status:
Registered
Patient Information leaflet
PERINDOPRIL AN (PERINDPRILL ERBUMINE)
1
PERINDOPRIL AN 2 MG
PERINDOPRIL AN 4 MG
PERINDOPRIL AN 8 MG
_perindopril (pronounced per-in-do-pril) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about PERINDOPRIL AN.
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 PERINDOPRIL
AN 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 PERINDOPRIL
AN IS
The name of your medicine is
PERINDOPRIL AN. The medicine
contains the active ingredient
perindopril erbumine. Perindopril
belongs to a group of medicines
called angiotensin converting
enzyme (ACE) inhibitors.
WHAT PERINDOPRIL
AN IS USED FOR
PERINDOPRIL AN is available only
with a doctor's prescription.
PERINDOPRIL AN 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.
PERINDOPRIL AN helps lower
your blood pressure.
You may be prescribed
PERINDOPRIL AN for heart failure.
Heart failure means that the heart
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Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION - PERINDOPRIL AN (PERINDOPRIL ERBUMINE)
Version: 9
1/24
AUSTRALIAN PI
PERINDOPRIL AN (PERINDOPRIL ERBUMINE) UNCOATED TABLETS
1
NAME OF THE MEDICINE
Perindopril erbumine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PERINDOPRIL AN 2 tablet contains 2 mg of perindopril erbumine.
Each PERINDOPRIL AN 4 tablet
contains 4 mg of perindopril erbumine. Each PERINDOPRIL AN 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
PERINDOPRIL AN 2: Round biconvex white uncoated tablets.
PERINDOPRIL AN 4: Rod-shaped biconvex scored white uncoated tablets.
PERINDOPRIL AN 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
PERINDOPRIL AN is indicated for:
•
the treatment of hypertension; and
•
the treatment of heart failure. In such patients it is recommended
that PERINDOPRIL AN be given with a
diuretic and/or digoxin under close medical supervision. (The safety
and efficacy of PERINDOPRIL AN
has not been demonstrated for New York Heart Association Category IV
patients).
4.2
D
OSE AND METHOD OF ADMINISTRATION
HYPERTENSION
The usual starting dose is one PERINDOPRIL AN 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 PERINDOPRIL AN 8 (8 mg) tablet once daily.
A starting dose of one PERINDOPRIL AN 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 PERINDOPRIL AN to patients under current
treatment with a diuretic may induce
hypotension and sometimes, but more rarely, acute renal failure, at
the beginning of the treatment.
Monitoring of plasma creatinine is recommended during the first mo
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