CITALOPRAM AMNEAL citalopram (as hydrobromide) 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

citalopram hydrobromide, Quantity: 12.495 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

citalopram hydrobromide

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

14, 7, 28, 56, 84

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression

Product summary:

Visual Identification: White to off white, round, plain, film coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-02-12

Patient Information leaflet

160527 Citalopram Amneal CMI v1
Page 1 of 8
CITALOPRAM AMNEAL
_FILM-COATED TABLETS _
_Contains the active ingredients citalopram hydrobromide _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet contains answers
to some common questions
about Citalopram AMNEAL.
It does not contain all the
information that is known
about Citalopram AMNEAL.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risk of you
using this medicine against
the benefits he/she expects it
will 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 CITALOPRAM
AMNEAL IS USED FOR
Citalopram AMNEAL 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 AMNEAL 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.
Citalopram AMNEAL 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 CITALOPRAM
AMNEAL.
BEFORE YOU

Summary of Product characteristics

CITALOPRAM AMNEAL
FILM-COATED TABLETS
1 of 22
NAME OF THE MEDICINE
Citalopram hydrobromide
CHEMICAL NAME:
1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-
carbonitrilehydrobromide. The active is present as a racemate.
CAS number:
[59729-32-7]
Molecular formula:
C
20
H
21
FN
2
O, HBr
Molecular weight:
405.3
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 diethylether. No
polymorphic forms have
been detected.
The
tablets
contain
the
following
excipients:
lactose,
maize
starch,
purified
water,
microcrystalline cellulose, croscarmellose sodium, magnesium stearate,
hypromellose,
titanium dioxide, purified talc, macrogol 400.
CITALOPRAM AMNEAL
FILM-COATED TABLETS
2 of 22
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Biochemical and behavioral 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
inhibitors (SSRI) yet developed, with no, or minimal effect on
noradrenaline (NA),
dopamine (DA) and gamma aminobutyric acid (GABA) uptake. In comparison
with other
Selective Serotonin Reuptake Inhibitors (SSRls) the decreasing order
of selectivity is
escitalopram, citalopram, sertraline, paroxetine, fluvoxamine and
f1uoxeline. The clinical
relevance of this in vitro finding has not been established.
In contrast to many tricyclic antidepressants and some of the newer
SSRls 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 receptors, β-adrenoceptors, histamine H
1
, muscarine
cholinergic, benzodiazepine, and opioid receptors. A series of
functional
_in vitro _
tests in
isolated organs as well as functi