AURO-CITALOPRAM 20 citalopram (as hydrobromide) 20 mg film-coated 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:

Strides Pharma Science Pty Ltd

INN (International Name):

citalopram hydrobromide

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; maize starch; copovidone; microcrystalline cellulose; lactose monohydrate; 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: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2010-01-11

Patient Information leaflet

AURO-CITALOPRAM
CONSUMER MEDICINE INFORMATION
Ver 1.2
AURO-CITALOPRAM 10, 20 & 40
Citalopram hydrobromide
CONSUMER MEDICINE INFORMATION
AURO-CITALOPRAM
Page 1 of 6
WHAT IS IN THIS LEAFLET?
Please
read
this
leaflet
carefully
before
you
start
AURO-
CITALOPRAM.
This
leaflet
answers
some common
questions
about
AURO-
CITALOPRAM.
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
AURO-CITALOPRAM
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
AURO-CITALOPRAM IS
USED FOR
AURO-CITALOPRAM 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.
AURO-CITALOPRAM 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
AURO-
CITALOPRAM
HAS
BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
AURO-CITALOPRAM
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
AURO-
CITALOPR

Summary of Product characteristics

Product Information:
AURO-CITALOPRAM 10, 20 & 40 (Citalopram Hydrobromide Tablets 10mg,
20mg & 40mg)
Ver 1.3
Page 1 of 18
PRODUCT INFORMATION
AURO-CITALOPRAM 10 (10MG CITALOPRAM AS CITALOPRAM HYDROBROMIDE)
AURO-CITALOPRAM 20 (20MG CITALOPRAM AS CITALOPRAM HYDROBROMIDE)
AURO-CITALOPRAM 40 (40MG CITALOPRAM AS CITALOPRAM HYDROBROMIDE)
NAME OF THE MEDICINE
The name of medicine is Citalopram as Citalopram hydrobromide.
O
CH
2
CH
2
CH
2
N
CH
3
CH
3
F
NC
HBr
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.
INACTIVE: Lactose, Maize starch, Copovidone, Croscarmellose sodium,
Cellulose microcrystalline,
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
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, α
1
receptors, α
2
recep