CILOPAM-S escitalopram (as oxalate) 5 mg tablet blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

escitalopram oxalate, Quantity: 6.37 mg (Equivalent: escitalopram, Qty 5 mg)

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

escitalopram oxalate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: purified talc; microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; titanium dioxide; magnesium stearate; macrogol 400; hypromellose

Administration route:

Oral

Units in package:

56, 98, 28, 14

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression.,Treatment of social anxiety disorder (social phobia).,Treatment of generalised anxiety disorder.,Treatment of obsessive-compulsive disorder.

Product summary:

Visual Identification: White to off-white, circular, biconvex, film-coated tablet with 'C5' embossed on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-09-25

Patient Information leaflet

CILOPAM-S™
CONSUMER MEDICINE INFORMATION
Escitalopram oxalate, 5 mg, 10 mg & 20 mg tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
CILOPAM-S. It does not
contain all the information that is known about CILOPAM-S.
It does not take the place of talking to your doctor and pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking this
medicine against the benefits they expect it will 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 CILOPAM-S IS FOR
CILOPAM-S 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.
CILOPAM-S corrects this chemical imbalance and may help relieve the
symptoms of depression.
CILOPAM-S may also be used to treat patients who may avoid and/or are
fearful of social
situations.
CILOPAM-S may also be used to treat patients who have excessive
anxiety and worry.
CILOPAM-S may also be used to treat irrational fears or obsessional
behaviour (obsessive-
compulsive disorder). Obsessive-compulsive disorder involves having
both obsessions and
compulsions. Obsessions are unwanted thoughts that occur over and over
again. Compulsions are
the ongoing need to repeat certain actions as a result of these
tho

Summary of Product characteristics

Page 2 of 27
_ _
PRODUCT INFORMATION
CILOPAM-S
FILM-COATED TABLETS
NAME OF THE MEDICINE
The active ingredient in CILOPAM-S is escitalopram oxalate
The structural formula is:
Chemical name: S(+)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3
dihydroisobenzofuran-5-carbonitrile hydrogen oxalate.
CAS number: 219861-08-2
Molecular formula: C
20
H
21
FN
2
O, C
2
H
2
O
4
Molecular weight: 414.42
DESCRIPTION
Escitalopram is the active enantiomer (S-enantiomer) of citalopram.
Escitalopram oxalate is
a fine white to yellow, crystalline material.
Escitalopram oxalate is sparingly soluble in water, slightly soluble
in acetone, soluble in
ethanol and freely soluble in methanol. No polymorphic forms have been
detected.
CILOPAM-S tablets contain the following excipients: microcrystalline
cellulose, colloidal
anhydrous silica, purified talc, croscarmellose sodium, magnesium
stearate, hypromellose,
macrogol 400 and titanium dioxide.
PHARMACOLOGY
Pharmacological actions
Biochemical and behavioural studies have shown that escitalopram is a
potent inhibitor of
serotonin (5-HT)-uptake (_in vitro _IC
50
2nM).
The antidepressant action of escitalopram is presumably linked to the
potentiation of
serotonergic activity in the central nervous system (CNS) resulting
from its inhibitory effect
on the reuptake of 5-HT from the synaptic cleft.
Escitalopram is a highly selective Serotonin Reuptake Inhibitor
(SSRI). On the basis of _in _
_vitro _studies, escitalopram had no, or minimal effect on
noradrenaline (NA), dopamine (DA)
and gamma aminobutyric acid (GABA) uptake.
Page 3 of 27
In contrast to many tricyclic antidepressants and some of the SSRIs,
escitalopram 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
-, α
2
-, β-adrenoceptors, histamine H
1
, muscarine cholinergic, benzodiazepine,
and opioid receptors. A series of functional _ in vitro _ tests in
isolated organs as well as
functional _in vivo _tests have confirmed the lack of receptor
affinity.
Escitalopram has