PERINDOPRIL AND INDAPAMIDE AN 4/1.25 perindopril erbumine 4mg / indapamide hemihydrate 1.25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

indapamide hemihydrate,perindopril erbumine

Available from:

Servier Laboratories Australia Pty Ltd

INN (International Name):

indapamide hemihydrate,Perindopril erbumine

Authorization status:

Registered

Patient Information leaflet

PERINDOPRIL AND INDAPAMIDE AN 4/1.25
1
PERINDOPRIL AND
INDAPAMIDE AN 4/1.25
_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 PRINDOPRIL AND
INDAPAMIDE AN 4/1.25. 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 PRINDOPRIL
AND INDAPAMIDE AN 4/1.25
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 PRINDOPRIL
AND INDAPAMIDE AN
4/1.25 IS
The name of your medicine is
PRINDOPRIL AND INDAPAMIDE
AN 4/1.25. The medicine contains
the active ingredients perindopril
erbumine 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 PRINDOPRIL
AND INDAPAMIDE AN
4/1.25 IS USED FOR
YOU HAVE BEEN PRESCRIBED
PRINDOPRIL AND
INDAPAMIDE AN 4/1.25 FOR HIGH
BLOOD PRESSURE.
PRINDOPRIL AND INDAPAMIDE
AN 4/1.25 is available only with a
doctor's prescription.
There is no evidence that
PRINDOPRIL AND INDAPAMIDE
AN 4/1.25 is addictive.
_WHY PRINDOPRIL AND _
_INDAPAMIDE AN 4/1.25 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,

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
PERINDOPRIL AND INDAPAMIDE AN 4/1.25 (PERINDOPRIL ERBUMINE /
INDAPAMIDE HEMIHYDRATE)
Version: 12
1/36
AUSTRALIAN PI - PERINDOPRIL AND INDAPAMIDE AN 4/1.25
(PERINDOPRIL ERBUMINE / INDAPAMIDE HEMIHYDRATE) UNCOATED
TABLETS
1
NAME OF THE MEDICINE
Perindopril erbumine / indapamide hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active components of PERINDOPRIL AND INDAPAMIDE AN 4/1.25 are
perindopril erbumine and
indapamide hemihydrate. Each PERINDOPRIL AND INDAPAMIDE AN 4/1.25
tablet contains 4 mg of
perindopril erbumine 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
PERINDOPRIL AND INDAPAMIDE AN 4/1.25 is a white rod-shaped uncoated
tablet.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of hypertension. Treatment should not be initiated with this
combination.
4.2
D
OSE AND METHOD OF ADMINISTRATION
One PERINDOPRIL AND INDAPAMIDE AN 4/1.25 tablet per day as a single
dose, preferably to be taken in
the morning.
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 daily dose in the elderly should always be at a low dose
or with one component only, and
patients should be monitored closely during the initial stages of
treatment.
Particular care should be taken in elderly patients with congestive
heart failure who have renal and/or
hepatic insufficiency (see_ section 4.4 - Special warnings and
precautions for use_).
PATIENTS WITH RENAL INSUFFICIENCY
In cases of severe renal insufficiency (creatinine clearance below 30
mL/min), the treatment is
contraindicated.
In patients with moderate renal insufficiency (creatinine clearance
30-60 mL/min), the maximum dose
should be a low dose or with one component only.
In patients with a creatinine clearance greater than 60 mL/min, no
do