CANDESARTAN AN candesartan cilexetil 32 mg tablet bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
candesartan cilexetil, Quantity: 32 mg
Available from:
Amneal Pharma Australia Pty Ltd
INN (International Name):
Candesartan cilexetil
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: lactose monohydrate; macrogol 8000; hyprolose; carmellose calcium; magnesium stearate; maize starch; iron oxide red
Administration route:
Oral
Units in package:
30 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Treatment of hypertension.,Treatment of patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction <=40percent) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.
Product summary:
Visual Identification: Light pink, round, biconvex uncoated mottled tablets debossed with L294 on one side and break line on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 12 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Registered
Authorization date:
2013-05-02
Patient Information leaflet
_Candesartan AN tablets – Consumer Medicine Information _
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_Doc ID: 46.AN.M.1.0 _
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_Page 1 _
CANDESARTAN AN TABLETS
_Candesartan cilexetil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
CANDESARTAN AN.
It
does
not
contain
all
of
the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the
risks
of
you
taking
CANDESARTAN AN 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 CANDESARTAN
AN IS USED FOR
CANDESARTAN AN belongs to
a group of medicines known as
angiotensin-II
receptor
antagonists.
CANDESARTAN AN is used to
treat:
high
blood
pressure,
also
called hypertension
heart
failure,
usually
in
combination
with
other
medicines.
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
hypertension
(high
blood
pressure)
which
means
your
blood pressure stays high, even
when you are calm and relaxed.
Regular blood pressure checks
are the only way of knowing that
you
have
hypertension.
There
are
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.
CANDESARTAN
AN
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 with
no
symptoms,
but
as
the
condition
progresses
Read the complete document
Summary of Product characteristics
_Candesartan AN tablets Product Information _
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_ Scentia Pharmaceuticals Pty Ltd _
Doc ID: 46.AN.P.1.0
Page 1
CANDESARTAN AN
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_(CANDESARTAN CILEXETIL TABLETS) _
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PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is candesartan cilexetil.
CHEMICAL
NAME:
(1_RS_)-1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl
2-ethoxy-1-[[2′-(1_H_-tetrazol-5-
yl)biphenyl-4-yl]methyl]-1_H_-benzimidazole-7-carboxylate
MOLECULAR FORMULA: C
33
H
34
N
6
O
6
MOLECULAR WEIGHT: 610.67
CAS REGISTRY NUMBER: 145040-37-5
DESCRIPTION
Candesartan cilexetil 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 CANDESARTAN AN.
CANDESARTAN AN tablets come in four strengths and contain 4 mg, 8 mg,
16 mg or 32 mg of
candesartan cilexetil. The tablets also contain lactose, carmellose
calcium, maize starch, macrogol
8000, hydroxypropylcellulose, magnesium stearate and Pigment Blend
PB-24880 Pink (ARTG
108327).. The tablets are gluten free.
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,
_Candesartan AN tablets Product Information _
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_ Scentia Pharmaceuticals Pty Ltd _
Doc ID: 46.AN.P.1.0
Page 2
regulation of salt and water homeostasis and stimulation of cell
growth, are mediated via the type 1
(AT
1
) receptor.
Candesartan cilexetil 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 recep
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