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

Authorization status:

Registered

Patient Information leaflet

CELICA CMI V9
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 your hear

Summary of Product characteristics

CELICA PI V9 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 CELICA film-coated tablet contains 20 mg citalopram (as
hydrobromide) and the following excipients:
microcrystalline cellulose, croscarmellose sodium, hypromellose,
lactose, macrogol 400, magnesium stearate, maize
starch, titanium dioxide, pregelatinised maize starch and purified
talc.
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 V9
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 a