ESCICOR 10 escitalopram (as oxalate) 10mg tablet blister pack

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

escitalopram oxalate, Quantity: 12.776 mg (Equivalent: escitalopram, Qty 10 mg)

Disponibbli minn:

Accord Healthcare Pty Ltd

INN (Isem Internazzjonali):

escitalopram oxalate

Għamla farmaċewtika:

Tablet, film coated

Kompożizzjoni:

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

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

28 Tablets in a pack

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Visual Identification: White to off-white, oval, biconvex film-coated tablets with breakline on one side and plain on other side having approximate dimensions, length about 8.0 mm and width about 5.5 mm.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2011-02-16

Fuljett ta 'informazzjoni

ESCICOR 10 & 20
CONSUMER MEDICINE INFORMATION VERSION 1.3
2012 Page: 1 of 6
ESCICOR 10 & 20
Escitalopram film-coated tablets 10 and 20 mg
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet contains answers to
some
common
questions
about
Escicor Tablets.
It
does
not
contain
all
the
information that is known about
Escicor Tablets. 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 ESCICOR IS USED
FOR
Escicor Tablets are 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.
Escicor
Tablets
corrects
this
chemical
imbalance
and
may
help
relieve
the
symptoms
of
depression.
Escicor
Tablets
may
also
be
used to treat patients who may
avoid and/or are fearful of social
situations.
Escicor
Tablets
may
also
be
used to treat patients who have
excessive anxiety and worry.
Escicor
Tablets
may
also
be
used to treat irrational fears or
obsessional behavior (obsessive-
compulsive
disorder).
Obsessive-compulsive
disorder
involves having both obsessions
and compulsions. Obsessions are
unwanted
thoughts
that
occ

Karatteristiċi tal-prodott

Escicor 10 and 20 Version 2.0
2011 Page 1 of 34
PRODUCT INFORMATION
ESCICOR 10/20
(ESCITALOPRAM FILM-COATED TABLETS 10/20 MG)
NAME OF THE MEDICINE
Escitalopram oxalate
Chemical name:-
_S-_
(
_+_
)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-
dihydroisobenzofuran-5-carbonitrile hydrogen oxalate
Structural formula:
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.
Escicor 10 and 20 Version 2.0
2011 Page 2 of 34
_Escicor 10 _
are white to off white, oval, biconvex, film-coated tablets with
breakline on
one side and plain on the other side having approximate dimensions
length about 8.0 mm
and width about 5.5 mm.
_Escicor 20 _
are white to off white, oval, biconvex, film-coated tablets with
breakline on
one side and plain on the other side having approximate dimensions,
length about 11.5
mm and width about 7.0 mm.
_Escicor _
also
contains
the
following
excipients:
microcrystalline
cellulose,
colloidal
anhydrous
silica,
purified
talc,
croscarmellose
sodium,
magnesium
stearate,
hypromellose, macrogol 400 and titanium dioxide.
PHARMACOLOGY
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.
In contrast to many