APO-CANDESARTAN HCTZ 32/12.5 candesartan cilexetil 32 mg & hydrochlorothiazide 12.5 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
30-07-2021
Summary of Product characteristics
(SPC)
30-07-2021
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
hydrochlorothiazide, Quantity: 12.5 mg; candesartan cilexetil, Quantity: 32 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Candesartan cilexetil,Hydrochlorothiazide
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: hyprolose; magnesium stearate; maize starch; lactose monohydrate; carmellose calcium; macrogol 8000; iron oxide yellow
Administration route:
Oral
Units in package:
30 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
The treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.
Product summary:
Visual Identification: Light yellow, oval biconvex uncoated mottled tablets debossed with 'L3' & '04' on either side of break line on one side & break line on one other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-07-16
Patient Information leaflet
APO-CANDESARTAN HCTZ TABLETS
1
APO-CANDESARTAN
HCTZ TABLETS
_Contains the active ingredient candesartan cilexetil and
hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about candesartan cilexetil
and hydrochlorothiazide (HCTZ). It
does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
Ask your doctor or pharmacist:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
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.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Candesartan HCTZ tablets. It
contains the active ingredients
candesartan cilexetil and
hydrochlorothiazide.
It is used to treat:
•
high blood pressure, also called
hypertension.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
They may differ from the
information contained in this leaflet.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
Candesartan cilexetil is a type of
medicine called an angiotensin II
receptor inhibitor (or antagonist). It
mainly works by causing relaxation
of blood vessels.
Hydrochlorothiazide is a type of
medicine called a diuretic. It works
by reducing the amount of excess
fluid in the body.
Using these two medicines together
wil
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
APO- CANDESARTAN HCTZ (CANDESARTAN CILEXETIL
AND HYDROCHLOROTHIAZIDE) TABLETS
1
NAME OF THE MEDICINE
Candesartan cilexetil and hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
16
mg
or
32
mg
candesartan
cilexetil
and
12.5
mg
or
25
mg
hydrochlorothiazide as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Sugars as lactose monohydrate.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CANDESARTAN HCTZ 16/12.5 TABLETS
Light pink, oval shape, biconvex, uncoated, mottled tablets debossed
with ‘L3’ and ’02’ on
either side of breakline on one side and break line on other side
CANDESARTAN HCTZ 32/12.5 MG TABLET
Light yellow, oval biconvex uncoated mottled tablets debossed with
'L3' & '04' on either side of
break line on one side & break line on one other side
CANDESARTAN HCTZ 32/25 MG TABLET
Light pink, oval biconvex uncoated mottled tablets debossed with 'L3'
& '04' on either side of
break line on one side & break line on one other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Candesartan HCTZ is indicated for the treatment of hypertension.
Treatment should not be
initiated with these fixed dose combinations.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- candesartan HCTZ are intended for oral administration.
DOSAGE
The dose of Candesartan HCTZ must be determined by careful titration
of the dose of each of
the individual components.
The recommended dose is 1 tablet once daily. Candesartan HCTZ may be
taken with or
without food. The tablets should not be divided.
Candesartan HCTZ 16/12.5 may be administered in patients whose blood
pressure is not
optimally controlled with hydrochlorothiazide alone or candesartan 16
mg monotherapy.
2
Candesartan HCTZ 32/12.5 or 32/25 may be administered in patients
whose blood pressure
is not optimally controlled with hydrochlorothiazide alone or
candesartan 32 mg monotherapy,
or
at
a
lower
dose
of
Candesartan
HCTZ.
Dose
titration
of
candesartan
cilexetil
is
recomm
Read the complete document
