Deprilept Tablets 10 mg

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

ESCITALOPRAM OXALATE

Disponible desde:

RANBAXY (MALAYSIA) SDN. BHD.

Designación común internacional (DCI):

ESCITALOPRAM OXALATE

Unidades en paquete:

14Tablet Tablets; 14Tablet Tablets

Fabricado por:

Sun Pharmaceutical Industries Limited

Información para el usuario

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
DEPRILEPT TABLETS
_ _
_ _
Escitalopram Oxalate (10mg, 20mg)
WHAT IS IN THIS LEAFLET
1.
What
DEPRILEPT
is used for
2.
How DEPRILEPT
works
3.
Before you use
DEPRILEPT
4.
How to use DEPRILEPT
5.
While you are using
DEPRILEPT
6.
Side effects
7.
Storage
and
disposal
of
DEPRILEPT
8.
Product description
9.
Manufacturer
and
Product
registration holder
10.
Date of revision
WHAT DEPRILEPT IS USED FOR
DEPRILEPT
is used to treat:

depression
(major
depressive
episodes
)

anxiety disorders (such as panic
disorder, social anxiety disorder)
HOW DEPRILEPT WORKS
DEPRILEPT
contains
escitalopram
which belongs to a group of medicines
called
SSRIs
(selective
serotonin
reuptake
inhibitors)
which
are
antidepressants.
They
are
thought
to
work
by
their
actions on serotonin-system in the brain
by
increasing
the
serotonin
level.
Disturbance in the serotonin levels are
thought to be responsible for depression
and related diseases.
Ask
your
doctor
if
you
have
any
questions
about
why
DEPRILEPT
have been prescribed for you.
BEFORE YOU USE DEPRILEPT
_- When you must not use it _
Do not take
DEPRILEPT
if you are:

Allergic
(hypersensitive)
to
escitalopram, citalopram or any of
the
other
ingredients
of
DEPRILEPT
as
mentioned
in
PRODUCT DESCRIPTION

An allergic reaction may include:

rash,

itching

swelling
of
face,
lips
or
hands/feet

breathing difficulties

Taking medicines that belong to
a
group
called
monoamine
oxidase inhibitors (MAOIs) e.g.
moclobemide (used for treatment
of
depression),
linezolid
(antibiotic) and selegiline (used
to treat Parkinson’s disease).

Taking
pimozide
(antipsychotic
medicine
used
to
treat
certain
mental disorders).

Born with or have had an episode
of abnormal heart rhythm.

Taking other medicines that are
known to affect the heart’s rhythm
(such as phenothiazine medicines,
pimozide,
haloperidol,
sparfloxacin,
moxifloxacin,
erythromycin,
pentamidine,
halofantrine,
astemizole,
mizolastine or certain
medicines
for irregular

Ficha técnica

1
_For the use of a Registered Medical Practitioner_ _or a Hospital or a
Laboratory Only. _
PRESCRIBING INFORMATION
DEPRILEPT TABLETS (10/20 MG)
(ESCITALOPRAM OXALATE TABLETS 10MG/20MG)
COMPOSITION
DEPRILEPT TABLETS 10 MG
EACH FILM COATED TABLET CONTAINS
Escitalopram oxalate 12.78 mg
equivalent to Escitalopram ........... 10 mg
Inactive components:
DEPRILEPT TABLETS 20 MG
Each film coated tablet contains
Escitalopram oxalate 25.55 mg
equivalent to Escitalopram ........... 20 mg
_INACTIVE COMPONENTS: _
_Microcrystalline Cellulose (PH101, Lactose Monohydrate, Copovidone
(Plasdone-S-630), Maize Starch _
_(Purity 21), Purified water, Silicified MCC (Prosolv SMCC 90),
Croscarmellose Sodium (AC-DI-SOL), _
_Purified Talc, Colloidal anhydrous silica, Magnesium stearate, Opadry
White OY-S-58910 _
PRODUCT DESCRIPTION
DEPRILEPT TABLETS 10 MG
White to off white oval biconvex film coated tablets debossed with 'E'
and '8' on either side of the eye
breakline on one side and plain on the other side.
DEPRILEPT TABLETS 20 MG
White to off white oval biconvex film coated tablets debossed with 'E'
and '9' on either side of the eye
breakline on one side and plain on the other side.
DESCRIPTION
DEPRILEPT contain escitalopram oxalate, which is an orally
administered selective serotonin reuptake
inhibitor
(SSRI).
Escitalopram
is
the
pure
S-enantiomer
(single
isomer)
of
the
racemic
bicyclic
phthalane derivative citalopram. Escitalopram oxalate is designated
S-(+)-1[3-(dimethyl-amino)propyl]-
1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following
structural formula.
2
STRUCTURAL FORMULA ESCITALOPRAM OXALATE
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES
Pharmacotherapeutic group: antidepressants, selective serotonin
reuptake inhibitors ATC-code: N 06
AB 10
_PHARMACODYNAMICS _
Escitalopram is a selective inhibitor of serotonin (5-HT) re-uptake
with high affinity for the primary
binding site. It also binds to an allosteric site on the serotonin
transporter, with a 1000-fold lower affinity.
Escitalopram has no or low affinity f