XALEXA 20 (Paroxetine Tablets 20 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PAROXETINE HYDROCHLORIDE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

PAROXETINE HYDROCHLORIDE

Unit dalam pakej:

3 x 10's tablet Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

XALEZA TABLETS
Paroxetine hydrochloride hemihydrate 20mg
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET
1.
What Paroxetine is used for
2.
How Paroxetine works
3.
Before you use Paroxetine
4.
How to use Paroxetine
5.
While you are using Paroxetine
6.
Side effects
7.
Storage and Disposal of Paroxetine
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT PAROXETINE IS USED FOR
Paroxetine is used to treat:

Depression

Obsessive-compulsive disorder
(repetitive, obsessive thoughts
with uncontrollable behaviour)

Panic disorder with and without
agoraphobia (fear of public and
open spaces)

Social anxiety or social phobia
(fear or avoidance of social
situations)

Generalised anxiety disorder
(generally feeling very anxious
or nervous)

Post-traumatic stress disorder
(anxiety:
caused by a traumatic
event)
HOW PAROXETINE WORKS
This medicine belongs to a group known
as selective serotonin reuptake inhibitor
(SSRI) antidepressants, which act by
inhibiting the neuronal uptake of
serotonin in the central nervous system,
thereby relieving the symptoms of
depression. Serotonin is one of several
brain chemicals called amines which are
involved in controlling mood.
BEFORE
YOU
USE
PAROXETINE_ _
_When you must not use it _
_Pregnancy and Breast-feeding: _
Ask your doctor or pharmacist for advice
before taking any medicine.
As there might be a small increased risk
of
birth
defects
(cardiovascular
malformation)
when
taking
Paroxetine
during
the
first
three
months
of
pregnancy.
It
is
important,
that
you
informed your doctor if you are planning
to
get
pregnant
or
if
you
are
already
pregnancy.
In
the
general
population,
about 1 in 100 babies are born with a
heart defect. This increased to about 2 in
100
babies
in
mothers
who
took
Paroxetine.
Your
doctor
will
have
to
decide
whether
treatment
with
Paroxetine
is
clearly
necessary
or
whether
an
alternative
treatment
is
possible for you.
You
should
not
discontinue
treatment
with Paroxetine abruptly.
Ma

Ciri produk

1.
PRODUCT NAME
XALEXA 20 (Paroxetine Tablets 20 mg)
2.
NAME AND STRENGTH OF ACTIVE INGREDIENT (S)
Paroxetine Tablets 20 mg
3.
PRODUCT DESCRIPTION
White to off-white coloured film –coated modified
capsule shaped, biconvex tablets debossed with
‘56’ on one side and ‘C’ with a deep break line on
the other side. Each film-coated tablet contains:
Paroxetine Hydrochloride Hemihydrate Ph. Eur.
equivalent to Paroxetine 20 mg.
4.
PHARMACODYNAMICS
/
PHARMACOKINETICS
PHARMACODYNAMICS
Paroxetine is a potent and selective inhibitor of
5-hydroxytryptamine
(5-HT,
serotonin)
reuptake
and its antidepressant action and efficacy in the
treatment of OCD, Social Anxiety disorder / Social
Phobia,
General Anxiety Disorder, Post-traumatic
Stress Disorder and panic disorder is thought to
be related
to its specific inhibition of 5-HT uptake
in brain neurons.
Paroxetine is chemically unrelated to the tricyclic,
tetracyclic
and
other
available
antidepressants.
Paroxetine
has
low
affinity
for
muscarinic
cholinergic
receptors
and
animal
studies
have
indicated
only
weak
anti-cholinergic
properties.
Paroxetine does not impair psychomotor function
and does not
potentiate the depressant effects of
ethanol.
In the treatment of depressive disorders, Paroxetine
exhibits
comparable
efficacy
to
standard
antidepressants.
Morning dosing with Paroxetine does not have any
detrimental effect on either the quality or
duration
of sleep. Moreover, patients are likely to experience
improved sleep as they respond to
Paroxetine
therapy.
Dose response:
In the fixed doses there is a flat dose response
curve,
providing
no
suggestion
of
advantage
in
terms
of
efficacy
for
using
higher
than
the
recommended doses.
Long-term efficacy:
The long-term efficacy of Paroxetine in treating
social anxiety disorder and generalised anxiety
disorder and Post-traumatic Stress Disorder has
not been sufficiently demonstrated.
PHARMACOKINETICS
Absorption:
Paroxetine
is
well
absorbed
after
oral
dosing
and
undergoes
first-pass
metabolism.
Due
to
first-pass
metabolism, the amo