PREXUM COMBI 5/1.25 perindopril arginine / indapamide hemihydrate film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

perindopril arginine, Quantity: 5 mg; indapamide hemihydrate, Quantity: 1.25 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

INN (International Name):

indapamide hemihydrate,perindopril arginine

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30 tablet (commercial presentation)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. Treatment should not be initiated with this combination.

Product summary:

Visual Identification: White, rod-shaped film-coated tablet (8mm long and 4mm wide).; 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:

Registered

Authorization date:

2012-08-13

Patient Information leaflet

PREXUM COMBI LD
2.5/0.625; PREXUM
COMBI 5/1.25
_perindopril (pronounced per-in-do-pril) and indapamide (pronounced
in-dap-a-mide)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about PREXUM COMBI.
It does not contain all the available
information about this medicine.
Reading this leaflet does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking PREXUM
COMBI against the expected benefits
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PREXUM
COMBI IS
The name of your medicine is
PREXUM COMBI. The medicine
contains the active ingredients
perindopril arginine and indapamide
hemihydrate. Perindopril belongs to a
group of medicines called
angiotensin converting enzyme
(ACE) inhibitors. Indapamide
belongs to a group of medicines
called diuretics (a type of "water"
tablet).
WHAT PREXUM
COMBI IS USED FOR
YOU HAVE BEEN PRESCRIBED
PREXUM COMBI FOR HIGH BLOOD
PRESSURE.
PREXUM COMBI is available only
with a doctor's prescription.
There is no evidence that PREXUM
COMBI is addictive.
_WHY PREXUM COMBI IS_
_USED FOR HIGH BLOOD_
_PRESSURE_
Everyone has blood pressure. This
pressure helps to circulate blood all
around the body. Your blood
pressure may be different at different
times of the day, depending on how
busy or stressed you are. You have
high blood pressure (also known as
hypertension) when your blood
pressure stays higher than is needed,
even when you are calm and relaxed.
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 COMBI helps to lower
your blood pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PREXUM
COMBI HAS BEEN PRESCRIBED FOR
YOU.
BEFORE YOU TAKE
PREXUM COMBI
There are some people who should
not

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
PREXUM COMBI (PERINDOPRIL ARGININE / INDAPAMIDE HEMIHYDRATE)
Version: 10
1/36
AUSTRALIAN PRODUCT INFORMATION
PREXUM COMBI (PERINDOPRIL ARGININE / INDAPAMIDE
HEMIHYDRATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Perindopril arginine / indapamide hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active components of PREXUM COMBI are perindopril arginine and
indapamide hemihydrate. Each
PREXUM COMBI LD 2.5/0.625 tablet contains 2.5 mg of perindopril
arginine and 0.625 mg of
indapamide hemihydrate. Each PREXUM COMBI 5/1.25 tablet contains 5 mg
of perindopril arginine and
1.25 mg of indapamide hemihydrate.
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 COMBI LD 2.5/0.625 is a white rod-shaped film-coated tablet
with an embossed line on both
faces. PREXUM COMBI 5/1.25 is a white, rod-shaped film-coated tablet.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PREXUM COMBI 5/1.25
Treatment of hypertension. Treatment should not be initiated with this
combination.
PREXUM COMBI LD 2.5/0.625
Treatment of hypertension.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment should be started at the normal dose of one PREXUM COMBI LD
2.5/0.625 tablet per day as
a single dose, preferably to be taken in the morning before a meal.
In cases where target blood pressure is not achieved, the dose should
be titrated to one tablet of PREXUM
COMBI 5/1.25 daily.
ELDERLY PATIENTS
Renal insufficiency is commonly observed in elderly people. Care
should therefore be taken when
prescribing perindopril-containing medicines to elderly hypertensive
patients.
The initial dose in the elderly should always be one tablet of PREXUM
COMBI LD 2.5/0.625 daily,
and patients should be monitored closely during the initial stages of
treatment.
AUSTRALIAN PRODUCT INFORMATION
PREXUM COMBI (PERINDOPRIL ARGININE / INDAPAMIDE HEMIHYDRATE)
Version: 10
2/36
Particular care should be taken in elderly patients with cong