PERINDOPRIL AND INDAPAMIDE-GH 4/1.25 mg TABLETS perindopril erbumine 4mg and indapamide hemihydrate1.25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

indapamide hemihydrate,perindopril erbumine

Available from:

Lupin Australia Pty Limited

INN (International Name):

indapamide hemihydrate,Perindopril erbumine

Authorization status:

Registered

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
PERINDOPRIL AND INDAPAMIDE-GH 4/1.25
(PERINDOPRIL ERBUMINE AND INDAPAMIDE HEMIHYDRATE) TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Perindopril and Indapamide-GH
4/1.25 mg tablets. 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
Perindopril and Indapamide-GH
4/1.25 mg tablets 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 PERINDOPRIL AND
INDAPAMIDE-GH 4/1.25 IS
USED FOR
The name of your medicine is
Perindopril and Indapamide-GH
4/1.25 mg tablets. 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).
YOU HAVE BEEN PRESCRIBED
PERINDOPRIL AND INDAPAMIDE-
GH 4/1.25 MG TABLETS FOR HIGH
BLOOD PRESSURE.
Perindopril and Indapamide-GH
4/1.25 mg tablets are available
only with a doctor's prescription.
There is no evidence that
Perindopril and Indapamide-GH
4/1.25 mg tablets are addictive.
_WHY PERINDOPRIL AND _
_INDAPAMIDE-GH 4/1.25 MG _
_TABLETS 4/1.25 MG 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 dis

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – PERINDOPRIL AND
INDAPAMIDE-GH 4/1.25
(PERINDOPRIL ERBUMINE AND INDAPAMIDE HEMIHYDRATE) TABLET
1
NAME OF THE MEDICINE
Perindopril erbumine and indapamide hemihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril
and
Indapamide
GH
4/1.25
mg
tablets
containing
perindopril
erbumine
4
mg
and
indapamide hemihydrate 1.25 mg
List of excipients with known effect: Lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Perindopril and Indapamide GH 4/1.25 mg tablets are white to
off-white; capsule shaped uncoated
tablets, plain on both sides.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF HYPERTENSION: Treatment should not be initiated with this
combination.
4.2 DOSE AND METHOD OF ADMINISTRATION
Note that Perindopril and Indapamide GH is not available in a 2/0.625
mg strength. Other brands should
be used if this dose strength is required.
One Perindopril and Indapamide GH 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 dose in the elderly should always be one tablet of the
perindopril 2 mg/ indapamide 0.625 mg
fixed dose combination product daily, and patients should be monitored
closely during the initial stages
of treatment.
Perindopril and Indapamide GH 4/1.25 v5.0
Page 2 of 35
(perindopril erbumine and indapamide hemihydrate) tablet
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 one