APL-CITALOPRAM 40 citalopram (as hydrobromide) 40 mg film-coated tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

citalopram hydrobromide, Quantity: 49.96 mg (Equivalent: citalopram, Qty 40 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

citalopram hydrobromide

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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 7 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:

Licence status A

Authorization date:

2012-07-26

Patient Information leaflet

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

Summary of Product characteristics

Product Information:
APL-CITALOPRAM 10, 20 & 40 (Citalopram Hydrobromide Tablets 10mg, 20mg
& 40mg)
Ver 1.2
Page 1 of 19
PRODUCT INFORMATION
APL-CITALOPRAM 10 (10MG CITALOPRAM AS CITALOPRAM HYDROBROMIDE)
APL-CITALOPRAM 20 (20MG CITALOPRAM AS CITALOPRAM HYDROBROMIDE)
APL-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,
microcrystalline cellulose,
Magnesium stearate & Opadry Complete Film Coat 03B58902 White (PI
number: 4503).
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,