CITALOPRAM AN citalopram hydrobromide 20 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

citalopram hydrobromide, Quantity: 24.98 mg (Equivalent: citalopram, Qty 20 mg)

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

citalopram hydrobromide

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; lactose monohydrate; copovidone; microcrystalline cellulose; purified water; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For Treatment of Major Depression

Product summary:

Visual Identification: White coloured, biconvex, capsule shaped film coated tablets debossed with A on one side and with a score line in between 0 and 6 on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2010-10-21

Patient Information leaflet

_Citalopram AN tablets – Consumer Medicine Information _
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_Citalopram AN CMI v 3 _
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_Page 1 _
CITALOPRAM AN TABLETS
_Citalopram hydrobromide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start CITALOPRAM
AN.
This
leaflet
answers
some
common
questions
about
CITALOPRAM AN. It does not
contain
all
the
available
information.
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
CITALOPRAM
AN
against
the
benefits it is expected to 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 CITALOPRAM
AN IS USED FOR
CITALOPRAM
AN
is
used
to
treat depression.
It
belongs
to
a
group
of
medicines
called
selective
serotonin
reuptake
inhibitors
(SSRIs).
They
are
thought
to
work by their actions on brain
chemicals called amines which
are involved in controlling mood.
Depression is longer lasting or
more
severe
than
the
"low
moods" everyone has from time
to
time
due
to
the
stress
of
everyday life. It is thought to be
caused by a chemical imbalance
in
parts
of
the
brain.
This
imbalance
affects
your
whole
body and can cause emotional
and physical symptoms such as
feeling
low
in
spirit,
loss
of
interest
in
activities,
being
unable
to
enjoy
life,
poor
appetite or overeating, disturbed
sleep,
often
waking
up
early,
loss of sex drive, lack of energy
and feeling guilty over nothing.
CITALOPRAM AN corrects this
chemical
imbalance
and
may
help
relieve
the
symptoms
of
depression.
Your
doctor,
however,
may
prescribe it for another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
ABOUT
WHY
CITALOPRAM
AN
HAS
BEEN
PRESCRIBED FOR YOU.
This medicine is only available
with a doctor's prescription.
CITALOPRAM
AN
is
not
addictive.
However,
if
you
suddenly stop taking it, you may
get side effects.
TELL YOUR DOCTOR IF YOU GET ANY
SIDE
EFFECTS
AFTER
STOPPING
AUROCITALOPR

Summary of Product characteristics

_Citalopram AN tablets Product Information Amneal Pharma Australia Pty
Ltd _
Citalopram AN PI v3
Page 1 of 18
CITALOPRAM AN
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_(CITALOPRAM HYDROBROMIDE TABLETS) _
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PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of medicine is Citalopram as Citalopram hydrobromide.
CHEMICAL NAME:
1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-
carbonitrile, monohydrobromide
MOLECULAR FORMULA:
C
20
H
21
FN
2
O.HBr
MOLECULAR WEIGHT:
405.3
CAS REGISTRY NUMBER: _[59729-32-7]_
DESCRIPTION
Citalopram Hydrobromide is a white to almost white, crystalline
powder.
Citalopram hydrobromide is sparingly soluble in water, soluble in
ethanol (96%), freely soluble in
chloroform and very slightly soluble in diethylether. No polymorphic
forms have been detected.
Citalopram AN tablets contain 10mg, 20mg or 40mg citalopram (as
citalopram hydrobromide)
INACTIVE:
Lactose
monohydrate,
Maize
starch,
Copovidone,
Croscarmellose
sodium,
Microcrystalline cellulose,
Magnesium stearate, Hypromellose, Macrogol 400 & Titanium dioxide.
PHARMACOLOGY
_PHARMACOLOGICAL ACTIONS_
Biochemical and behavioural studies have shown that citalopram is a
potent inhibitor of serotonin
(5-HT)-uptake. Tolerance to the inhibition of 5-HT-uptake is not
induced by long-term treatment
with citalopram.
On the basis of in vitro studies, citalopram is one of the most
selective Serotonin Reuptake Inhibitor
(SSRI) yet developed, with no, or minimal effect on noradrenaline
(NA), dopamine (DA) and
gamma aminobutyric acid (GABA) uptake. In comparison with other SSRIs
the decreasing order of
selectivity is escitalopram, citalopram, sertraline, paroxetine,
fluvoxamine and fluoxetine. The
_Citalopram AN tablets Product Information Amneal Pharma Australia Pty
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Citalopram AN PI v3
Page 2 of 18
clinical relevance of this in vitro finding has not been established.
In contrast to many tricyclic antidepressants and some of the newer
SSRIs, citalopram has no or
very low affinity for a series of receptors including 5-HT
1A
, 5-HT
2
, DA D
1
and DA D
2
receptors,