CANDELEM candesartan cilexetil 8 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
12-12-2016
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
candesartan cilexetil, Quantity: 8 mg
Available from:
Alembic Pharmaceuticals Australia Pty Ltd
INN (International Name):
Candesartan cilexetil
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: hyprolose; lactose monohydrate; maize starch; macrogol 8000; magnesium stearate; carmellose calcium; 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 292 on one side and break line on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-05-02
Patient Information leaflet
CTAN/122016/CMI-1
1
CTAN
_contains the active ingredient candesartan cilexetil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CTAN.
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 CTAN against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to read it
again.
WHAT CTAN IS USED FOR
CTAN belongs to a group of
medicines known as angiotensin-II
receptor antagonists.
CTAN is used to treat:
high blood pressure, also called
hypertension; and
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.
CTAN 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, patients may feel short
of breath or may get tired easily
after light physical activity such as
walking. Some patients m
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Summary of Product characteristics
CTAN
Candesartan cilexetil 4 mg, 8 mg, 16 mg & 32 mg tablets
_ _
_PRODUCT INFORMATION_
_ _
NAME OF THE MEDICINE
Candesartan
cilexetil.
The
chemical
name
for
candesartan
cilexetil
is
(1RS)-1-
[[(Cyclohexyloxy)carbonyl]oxy]ethyl2-ethoxy-1-[[2′-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-enzimidazole-
7-carboxylate.
Its structural formula is:
C
33
H
34
N
6
O
6
Molecular weight: 611
CAS No.: 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 CTAN.
CTAN tablets come in four strengths and contain 4 mg, 8 mg, 16 mg or
32 mg of candesartan
cilexetil. The tablets also contain lactose monohydrate, carmellose
calcium, maize starch, macrogol
8000, hyprolose, magnesium stearate and Pigment Blend PB-24880 Pink
(ARTG 108327) which
contains iron oxide red and lactose monohydrate. 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, regulation of salt
and water homeostasis and stimulation of cell growth, are mediated via
the type 1 (AT
1
) receptor.
CTAN – Product information
Page 2 of 13
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
receptor antagonist, selective for AT
1
receptors, with tight binding to and slow dissociation from the
receptor. It has no agonist activity.
Candesartan
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