CANDESARTAN HCTZ AN 16/12.5 candesartan cilexetil 16 mg & hydrochlorothiazide 12.5 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrochlorothiazide, Quantity: 12.5 mg; candesartan cilexetil, Quantity: 16 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Candesartan cilexetil,Hydrochlorothiazide

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; carmellose calcium; maize starch; lactose monohydrate; macrogol 8000; hyprolose; iron oxide red

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.

Product summary:

Visual Identification: Light pink, oval, biconvex uncoated mottled tablets debossed with 'L3' & '02' on either side of break line on one side & break line on one other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 6 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2012-12-05

Patient Information leaflet

_Candesartan HCTZ AN tablets – Consumer Medicine Information _
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_Doc ID: 45.AN.M.1.0 _
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_ _
_Page 1 _
CANDESARTAN HCTZ AN TABLETS
_Candesartan cilexetil and hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
CANDESARTAN HCTZ 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
HCTZ
AN
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 CANDESARTAN
HCTZ AN IS USED FOR
CANDESARTAN
HCTZ
AN
is
used
to
treat
high
blood
pressure,
also
called
hypertension.
CANDESARTAN
HCTZ
AN
contains
two
medicines,
candesartan
cilexetil
and
hydrochlorothiazide.
In
combination,
they
lower
your
blood pressure more than using
either one on its own.
Candesartan cilexetil belongs to
a group of medicines known as
angiotensin-II
receptor
antagonists. It works by relaxing
the blood vessels.
Hydrochlorothiazide is a diuretic.
It works by reducing the amount
of fluid in the body.
Your
doctor
will
have
explained
why
you
are
being
treated
with
Candesartan/
hydrochlorothiazide
tablets and told you what dose to
take.
Your
doctor
may
have
prescribed
CANDESARTAN
HCTZ AN for another reason.
Ask your doctor if you have any
questions
about
why
CANDESARTAN HCTZ AN has
been prescribed for you.
CANDESARTAN
HCTZ
AN
is
available
only
with
a
doctor's
prescription.
BEFORE YOU TAKE
CANDESARTAN
HCTZ AN
_WHEN YOU MUST NOT TAKE _
_IT _
DO
NOT
TAKE
CANDESARTAN
HCTZ AN IF YOU ARE ALLERGIC TO:

medicines
containing
candesartan cilexetil

other angiotensin II receptor
antagonists

any
sulphur
drugs
(sulphonamides)
such
as
some
antibiotics
or
some
medicines to treat diabetes

any of the ingredients listed
at the end of this leaflet.
Symptoms of an

Summary of Product characteristics

_Candesartan HCTZ AN tablets Product Information _
_ _
_Scentia Pharmaceuticals Pty Ltd _
Doc ID: 45.AN.P.1.1
Page 1
CANDESARTAN HCTZ AN 16/12.5, 32/12.5 & 32/25
_ _
_(CANDESARTAN CILEXETIL 16 MG & HYDROCHLOROTHIAZIDE 12.5 MG TABLETS _
_CANDESARTAN CILEXETIL 32 MG & HYDROCHLOROTHIAZIDE 12.5 MG TABLETS _
_CANDESARTAN CILEXETIL 32 MG & HYDROCHLOROTHIAZIDE 25 MG TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is candersartan cilexetil and
hydrochlorothiazide.
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: 611
CAS REGISTRY NUMBER: _[145040-37-5] _
HYDROCHLOROTHIAZIDE
CHEMICAL NAME:
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide
MOLECULAR FORMULA: C
7
H
8
ClN
3
O
4
S
2
MOLECULAR WEIGHT: 297.7
CAS REGISTRY NUMBER: _[58-93-5] _
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 HCTZ AN 16/12.5, 32/12.5 & 32/25.
_Candesartan HCTZ AN tablets Product Information _
_ _
_Scentia Pharmaceuticals Pty Ltd _
Doc ID: 45.AN.P.1.1
Page 2
Hydrochlorothiazide is a white, crystalline powder. It is very
slightly soluble in water, soluble in
acetone, sparingly soluble in ethanol (96 per cent).
It dissolves in dilute solutions of alkali
hydroxides.
Candesartan HCTZ AN 16/12.5, 32/12.5 & 32/25 tablets come in three
strengths and contain 16 mg
of candesartan cilexetil and 12.5 mg of hydrochlorothiazide, 32 mg of
candesartan cilexetil and
12.5 mg of hydrochlorothiazide or 32 mg of candesartan and 25 mg of
hydrochlorothiazide. The
tablets
also
contain
lactose,
carmellose
calcium,
maize
starch,
macrogol
8000,
hydroxypropylcell