APO-IRBESARTAN HCTZ 300/12.5 irbesartan and hydrochlorothiazide 300/12.5mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
23-11-2021
Summary of Product characteristics
(SPC)
20-04-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
irbesartan, Quantity: 300 mg; hydrochlorothiazide, Quantity: 12.5 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Hydrochlorothiazide,Irbesartan
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: lactose monohydrate; povidone; magnesium stearate; croscarmellose sodium; iron oxide yellow; iron oxide red; titanium dioxide; hypromellose; macrogol 4000
Administration route:
Oral
Units in package:
30s
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
For the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.
Product summary:
Visual Identification: Peach coloured, oval shaped, biconvex, film coated tablet, debossed with "L184" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2013-09-26
Patient Information leaflet
APO- IRBESARTAN HCTZ TABLETS
1
APO-IRBESARTAN HCTZ
TABLETS
_Irbesartan and hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about irbesartan HCTZ. It
does not contain all the available
information. It 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 using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Irbesartan HCTZ is used to treat high
blood pressure (hypertension).
Everyone has blood pressure. This
pressure helps get your blood all
around your 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 which means
your blood pressure stays high, even
when you are calm and relaxed.
There are usually no symptoms of
high blood pressure. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regularly basis.
_HOW IT WORKS _
This product contains both irbesartan
and hydrochlorothiazide (HCTZ).
Both medicines reduce blood
pressure in different ways.
Irbesartan belongs to a group of
medicines known as angiotensin-II
receptor antagonists. Angiotensin II
is a substance produced in the body
which causes blood vessels to
tighten. Irbesartan blocks
angiotensin-II and therefore relaxes
your blood vessels. This helps to
lower your blood pressure.
HCTZ belongs to the class of
medicines known as diuretics.
Diuretics cause an increase in the
volume of urine. They also help with
lowering blood pressure particularly
when combined with other blood
pressure reducing medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may h
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
APO-IRBESARTAN HCTZ
(IRBESARTAN/HYDROCHLOROTHIAZIDE) TABLETS
1
NAME OF THE MEDICINE
Irbesartan and Hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg or 300 mg irbesartan and 12.5 mg or 25 mg
hydrochlorothiazide,
as the active ingredients.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
150/12.5 MG TABLETS: peach, oval, biconvex film-coated tablet debossed
with "L183" on one
side and plain on the other side.
300/12.5 MG TABLETS: peach, oval, biconvex film-coated tablet debossed
with "L184" on one
side and plain on the other side.
300/25 MG TABLETS: pinkish brown, oval, biconvex film-coated tablet
debossed with "L185" on
one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Irbesartan/hydrochlorothiazide is indicated for the treatment of
hypertension. Treatment should
not be initiated with this fixed-dose combination.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Irbesartan HCTZ tablets are intended for oral administration.
DOSAGE
Irbesartan/hydrochlorothiazide should not be initiated as first-line
therapy. The daily dose can
be administered with or without food.
REPLACEMENT THERAPY
The combination may be substituted for the titrated components at the
same dose level.
DOSE TITRATION BY CLINICAL EFFECT
When clinically appropriate, direct change from monotherapy to the
fixed combinations may
be considered:
Irbesartan 150 mg/hydrochlorothiazide 12.5 mg may be administered to
patients whose blood
pressure is not adequately controlled with hydrochlorothiazide or
irbesartan 150 mg alone.
2
Irbesartan 300 mg/hydrochlorothiazide 12.5 mg may be administered to
patients insufficiently
controlled by irbesartan 300 mg or by irbesartan 150
mg/hydrochlorothiazide 12.5 mg.
Irbesartan 300 mg/hydrochlorothiazide 25 mg may be administered to
patients insufficiently
controlled by irbesartan 300 mg/hydrochlorothiazide 12.5 mg.
Doses
higher
th
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