CHEMMART CANDESARTAN candesartan cilexetil 32 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
15-09-2014
Summary of Product characteristics
(SPC)
03-07-2018
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
candesartan cilexetil
Available from:
Apotex Pty Ltd
INN (International Name):
Candesartan cilexetil
Authorization status:
Registered
Patient Information leaflet
CHEMMART CANDESARTAN
TABLETS
_Contains the active ingredient candesartan cilexetil_
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. 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.
You can also download the most up
to date leaflet from
www.apotex.com.au.
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. It contains
the active ingredient candesartan
cilexetil.
It is used to treat:
•
high blood pressure, also called
hypertension.
•
heart failure - increase survival,
reduce hospitalisation and
improve symptoms. It is used in
combination with other medicines
to treat your condition.
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.
There is no evidence that this
medicine is addictive.
_HOW IT WORKS_
Candesartan is a type of medicine
called an angiotensin II receptor
inhibitor (or antagonist).
HYPERTENSION:
All people have blood pressure. This
pressure helps to push blood all
around your body. Your blood
pressure changes during th
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Summary of Product characteristics
Product Information – Australia
Chemmart Candesartan Tablets
Page 1
CHEMMART CANDESARTAN TABLETS
NAME OF THE MEDICINE
Candesartan cilexetil
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:
610.7
CAS Registry Number:
145040-37-5
DESCRIPTION
It is a white to off white powder and is practically insoluble in
water. It has a pKa of 6.3, corresponding to
deprontonation of the tetrazole ring. The partition coefficient of
candesartan cilexetil is as follows:
pH of Aqueous
Layer
Partition Coefficient (K at 20°C)
Ethyl Ether
1-Octanol
1.1
> 1000
> 1000
6.9
> 1000
> 1000
8.9
141
> 1000
K =
Concentration of Candesartan cilexetil in the organic layer
Concentration of Candesartan cilexetil in the aqueous layer
Three polymorphic forms have been identified; crystal form I, crystal
form II and an amorphous form.
Crystalline form I is used in Chemmart Candesartan.
Each Candesartan tablet contains candesartan cilexetil as the active
ingredient. In addition, each
Candesartan tablet contains the following inactive ingredients:
lactose, carmellose calcium, maize starch ,
macrogol 8000, hydroxypropylcellulose, magnesium stearate and Pigment
Blend PB-24880 Pink (ARTG
108327) which contains iron oxide red and lactose. 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, heart failure
and other cardiovascular disorders. It
Product Information – Australia
Chemmart Candesartan Tablets
Page 2
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 (AT
1
) receptor.
Can
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