APO-PERINDOPRIL ARGININE perindopril arginine 2.5 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

perindopril arginine

Available from:

Apotex Pty Ltd

INN (International Name):

perindopril arginine

Authorization status:

Registered

Patient Information leaflet

APO-PERINDOPRIL
ARGININE
_Contains the active ingredient perindopril arginine_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about perindopril arginine.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Perindopril Arginine tablets.
It contains the active ingredient
perindopril arginine.
Perindopril belongs to a group of
medicines called angiotensin
converting enzyme (ACE) inhibitors.
It is used to treat high blood pressure,
heart failure or coronary artery
disease.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HIGH BLOOD PRESSURE_
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

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-
PERINDOPRIL ARGININE (PERINDOPRIL ARGININE)
TABLETS
1
NAME OF THE MEDICINE
Perindopril Arginine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg, 5 mg or 10 mg perindopril arginine, as
the active ingredient.
3
PHARMACEUTICAL FORM
2.5 MG TABLETS:
White coloured, round shaped, biconvex, film coated tablets, with
engraved “APO” on one side
and “2.5” on the other side.
5 MG TABLETS:
Light green coloured, capsule-shaped, biconvex, film coated tablets,
with notch and engraved
“APO” on one side and “P 5” on the other side.
10 MG TABLETS:
Green coloured, round shaped, biconvex, film coated tablets, with
engraved “APO” on one
side and “P 10” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
The treatment of hypertension.
•
The treatment of heart failure. In such patients it is recommended
that perindopril
arginine be given with a diuretic and/or digoxin under close medical
supervision. (The
safety and efficacy of perindopril arginine 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, 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Perindopril Arginine tablets are intended for oral administration.
HYPERTENSION
The usual starting dose is one perindopril arginine
5 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 arginine
10 mg tablet once daily.
A starting dose of one perindopril arginine
2.5 mg tablet per day is recommended in the
following patients who may be at risk of ACE inhibitor-induced
hypotension:
2
Combination with a Diuretic
The administration of perindopril arginine to patients currently
treat