AURO-CANDESARTAN 8 candesartan cilexetil 8 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
09-12-2015
Summary of Product characteristics
(SPC)
09-12-2015
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
Candesartan cilexetil
Available from:
Aurobindo Pharma Australia Pty Ltd
INN (International Name):
Candesartan cilexetil
Patient Information leaflet
AURO-CANDESARTAN™ 4, 8, 16 AND 32
CONSUMER MEDICINE INFORMATION
Candesartan cilexetil tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
AURO-CANDESARTAN.
It does not contain all the information that is known about
AURO-CANDESARTAN. 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 taking AURO-
CANDESARTAN 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 need to read it again.
WHAT AURO-CANDESARTAN IS USED FOR
Candesartan cilexetil is a type of medicine called an angiotensin II -
receptor antagonist (or blocker).
AURO-CANDESARTAN is used to treat high blood pressure, also called
hypertension.
AURO-CANDESARTAN is also used to treat heart failure. It is used in
combination with other
medicines to treat your condition.
HYPERTENSION:
All people have blood pressure. This pressure helps to push blood all
around your body. Your blood
pressure changes during the day, depending on how busy you are or how
you are feeling.
You have hypertension (high blood pressure) when your blood pressure
stays higher than is needed,
even when you are calm and relaxed.
Regular blood pressure checks are the only way of knowing that you
have hypertension. There are
usually no symptoms of hypertension and you may feel fine. If
hypertension is not treated, serious
health problems such as stroke or heart attack and heart or kidney
failure may occur.
AURO-CANDESARTAN lowers blood pressure by dilating (expanding) small
blood vessels from the
heart, letting the blood be pumped around the body more easily.
HEART FAILURE:
Heart failure means that the heart muscle cannot pump blood strongly
enough to supply all the blood
needed throughout the body. Heart failure is not the same as heart
attack and does not mean that
the heart stops working.
Heart failure may start off wit
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Summary of Product characteristics
Page 1 of 14
PRODUCT INFORMATION
AURO-CANDESARTAN 4, 8, 16 AND 32
TABLETS
NAME OF THE MEDICINE
Active ingredient:
candesartan cilexetil
Chemical name:
(1RS)-1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl 2-ethoxy-1-[[2′-(1H-
tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylate.
CAS number:
145040-37-5
Molecular weight:
611
Molecular formula:
C
33
H
34
N
6
O
6
Chemical structure:
DESCRIPTION
It is a white or almost white powder and is practically insoluble in
water, freely soluble in methylene
chloride and slightly soluble in anhydrous ethanol. Three polymorphic
forms have been identified;
crystal form I, crystal form II and an amorphous form. Crystalline
form I is used in
AURO-
CANDESARTAN.
AURO-CANDESARTAN is available as tablets containing 4 mg, 8 mg, 16 mg
or 32 mg of
candesartan cilexetil.
AURO-CANDESARTAN tablets contain the following inactive ingredients:
lactose, carmellose
calcium, hydroxypropylcellulose, magnesium stearate, aluminium
magnesium silicate, propylene
glycol, iron oxide red (8 mg only) & iron oxide yellow (16 & 32 mg
only).
PHARMACOLOGY
PHARMACODYNAMICS
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
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.
Page 2 of 14
Candesartan is a
prodrug suitable for
oral use.
It is rapidly converted to the active drug,
candesartan, by ester hydrolysis during absorption from the
gastrointestinal tract. Candesartan is
an angiotensin II receptor antagonist, selective for AT
1
receptors, with tight binding to and slow
dissociation from the receptor. It has no agonist activity.
Candesartan does not inhibit angiotensin converting enzyme (ACE),
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