CELICA citalopram (as hydrobromide) 20 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

citalopram hydrobromide

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

citalopram hydrobromide

Patient Information leaflet

CELICA CMI V8 Jan 2012
1
CELICA
_CITALOPRAM (AS CITALOPRAM HYDROBROMIDE) 20 MG TABLETS_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
CELICA.
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 using
CELICA against the benefits it
is expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the
medicine. You may need to
read it again.
WHAT CELICA IS USED FOR
CELICA 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.
CELICA 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 it has
been prescribed for you.
This medicine is only available
with a doctor's prescription.
CELICA 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
CELICA.
BEFORE YOU TAKE CELICA
_ _
_WHEN YOU MUST NOT TAKE IT_
Do not take CELICA if you
have a condition called
congenital long QT syndrome.
At high doses, CELICA can
cause changes in the way that

Summary of Product characteristics

CELICA PI V8 Jan 2012
CELICA TABLETS
NAME OF THE MEDICINE
Citalopram hydrobromide
CHEMICAL NAME:
1-(3-dimethylaminopropyl)-1-(4-flurophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile
hydrobromide. The active is
present as a racemate.
CAS NUMBER:
[59729-32-7]
MOLECULAR FORMULA:
C
20
H
21
FN
2
O
1
HBr
MOLECULAR WEIGHT:
405.32
STRUCTURAL FORMULA:
DESCRIPTION
Citalopram hydrobromide is a fine white to off-white, crystalline
material.
Citalopram hydrobromide is sparingly soluble in water, soluble in
ethanol (96%), freely soluble in chloroform and very
slightly soluble in diethyl ether. No polymorphic forms have been
detected.
Each film-coated tablet of CELICA contains 20 mg citalopram (as
hydrobromide) and the following excipients: lactose,
maize starch, copovidone, croscarmellose sodium, microcrystalline
cellulose, magnesium stearate and Opadry complete
film coating system 03B58902 white.
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 SSRI’s 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.
CELICA PI V8 Jan 2012
Page 2 of 16
In contrast to many tricyclic antidepressants and some of the newer
SSRIs , citalopram has no or very low affinity for a
series of receptors including5-HT
1a
, 5-HT
2
, DA D
1
and DA D
2
receptors, α1 receptors , α2 receptors , β-andrenoceptors,
histamine H1, muscarine cholinergic, benzodiazepine, and opioid
receptors. A series of functional _in vitro_ tests in
isolated organs as well as functional _in viv