APX-PERINDOPRIL ARGININE perindopril arginine 5 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

perindopril arginine, Quantity: 5 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

INN (International Name):

perindopril arginine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; hydrophobic colloidal silica anhydrous; macrogol 6000; sodium starch glycollate; maltodextrin; lactose monohydrate; Colour

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APX-PERINDOPRIL ARGININE is indicated for: the treatment of hypertension; and the treatment of heart failure. In such patients it is recommended that APX-PERINDOPRIL ARGININE be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of APX-PERINDOPRIL ARGININE 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: Light-green, rod-shaped film-coated tablet engraved with Servier logo one one face and scored on both edges; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-02-16

Patient Information leaflet

APX-PERINDOPRIL ARGININE
1
APX-PERINDOPRIL
ARGININE
_2.5; 5; 10 _
_perindopril (pronounced per-in-do-pril) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about APX-
PERINDOPRIL ARGININE. 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 APX-
PERINDOPRIL ARGININE 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 APX-
PERINDOPRIL
ARGININE IS
The name of your medicine is APX-
PERINDOPRIL ARGININE. The
medicine contains the active
ingredient perindopril arginine.
Perindopril belongs to a group of
medicines called angiotensin
converting enzyme (ACE) inhibitors.
WHAT APX-
PERINDOPRIL
ARGININE IS USED
FOR
APX-PERINDOPRIL ARGININE is
available only with a doctor's
prescription.
APX-PERINDOPRIL ARGININE
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. APX-
PERINDOPRIL ARGININE helps
lower your blood pressure.
You may be prescribed APX-
PERINDOPRIL

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – APX-PERINDOPRIL ARGININE
(PERINDOPRIL ARGININE)
Version: 1
1/26
AUSTRALIAN PRODUCT INFORMATION
APX-PERINDOPRIL ARGININE (PERINDOPRIL ARGININE) FILM-
COATED TABLETS
1
NAME OF THE MEDICINE
Perindopril arginine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-PERINDOPRIL ARGININE tablet contains 2.5 mg, 5 mg, or 10 mg of
perindopril arginine.
Excipient with known effect: sugars as lactose
For the full list of excipients, _see section 6.1 - List of
excipients_.
3
PHARMACEUTICAL FORM
APX-PERINDOPRIL ARGININE 2.5 mg is a white, round, convex, film-coated
tablet.
APX-PERINDOPRIL ARGININE 5 mg is a light-green, rod-shaped,
film-coated tablet engraved with a
logo on one face and scored on both edges.
APX-PERINDOPRIL ARGININE 10 mg is a green, round, biconvex film-coated
tablet with a
logo on
one face and a
logo on the other face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
APX-PERINDOPRIL ARGININE is indicated for:
•
the treatment of hypertension;
•
the treatment of heart failure. In such patients it is recommended
that APX-PERINDOPRIL
ARGININE be given with a diuretic and/or digoxin under close medical
supervision. (The safety
and efficacy of APX-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_) 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 APX-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 APX-PERINDOPRIL ARGININE 10 mg
tablet once daily.
AUSTRALIAN PRODUCT INFORMATION – APX-PERINDOPRIL ARGININE
(PERINDOPRIL ARGININE)
Version: 1
2/26
A starting dose of one APX-PERINDOPRIL ARGININE 2.5 mg tablet onc