PREXUM 2.5 perindopril arginine 2.5 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

perindopril arginine, Quantity: 2.5 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

INN (International Name):

perindopril arginine

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PREXUM is indicated for: the treatment of hypertension; and the treatment of heart failure. In such patients it is recommended that PREXUM be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of PREXUM 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: White, round, convex, film-coated tablet; 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:

2013-02-12

Patient Information leaflet

PREXUM
® 2.5
PREXUM
® 5
PREXUM
® 10
_perindopril (pronounced per-in-do-pril)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about PREXUM. 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 PREXUM 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 PREXUM IS
The name of your medicine is
PREXUM. The medicine contains
the active ingredient perindopril
arginine. Perindopril belongs to a
group of medicines called
angiotensin converting enzyme
(ACE) inhibitors.
WHAT PREXUM IS
USED FOR
PREXUM is available only with a
doctor's prescription.
PREXUM 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. PREXUM
helps lower your blood pressure.
You may be prescribed PREXUM
for heart failure. Heart failure means
that the heart muscle cannot pump
blood strongly enough to supply all
the blood needed throughout the
body. Heart failure is not the same as
heart a

Summary of Product characteristics

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