CHEMMART 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)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
candesartan cilexetil,hydrochlorothiazide
Available from:
Apotex Pty Ltd
INN (International Name):
Candesartan cilexetil,Hydrochlorothiazide
Authorization status:
Registered
Patient Information leaflet
CHEMMART 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
Chemmart 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.
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
will lower your blood pressure more
effectively than using either one on
its own.
There is n
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Summary of Product characteristics
Product Information – Australia
Chemmart Candesartan HCTZ Tablets
Page 1
CHEMMART CANDESARTAN HCTZ TABLETS
NAME OF THE MEDICINE
Candesartan cilexetil and hydrochlorothiazide
CANDESARTAN
Chemical Name:
(±)-1-(cyclohexyloxycarbonyl-oxy) ethyl
2-ethoxy-1-[[2’-(1H-tetrazol-5-yl)
biphenyl-4-yl] methyl]-1H-benzimadozole-7-carboxylate
Structural Formula:
Molecular Formula:
C
33
H
34
N
6
O
6
Molecular Weight:
610.67
CAS Registry Number:
145040-37-5
HYDROCHLOROTHIAZIDE
Chemical Name:
6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulphonamide 1,
1-dioxide.
Structural Formula:
Molecular Formula:
C
7
H
8
N
3
S
2
O
4
Cl
Molecular Weight:
297.75
CAS Registry Number:
58-93-5
DESCRIPTION
Candesartan is a white to off white powder and is practically
insoluble in water. Hydrochlorothiazide is a
sulfonamide derived drug. It is a white, or almost white crystalline
powder and is very slightly soluble in
water.
Product Information – Australia
Chemmart Candesartan HCTZ Tablets
Page 2
Each tablet contains 16 mg or 32 mg candesartan cilexetil and 12.5 mg
or 25 hydrochlorothiazide as the
active ingredient.
In addition, each tablet contains the following inactive ingredients
lactose, carmellose calcium, starch –
maize, macrogol 8000, hydroxypropylcellulose, magnesium stearate,
Pigment Blend PB-24880 Pink (
16/12.5 mg and 32/25 mg tablets only) and iron oxide yellow in the
32/12.5 mg tablets only. The tablets
are gluten free.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Angiotensin II is the primary vasoactive hormone of the
renin-angiotensin-aldosterone system and plays a
significant role in the pathophysiology of hypertension and other
cardiovascular disorders. It also has an
important role in the pathogenesis of end organ hypertrophy and
damage. The major physiological effects
of
angiotensin
II,
such
as
vasoconstriction,
aldosterone
stimulation,
regulation
of
salt
and
water
homeostasis and stimulation of cell growth, are mediated via the type
1 (AT1) receptor.
Candesartan cilexetil is a prodrug suitable for oral use. It is
rapidly co
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