Seroxat CR Tablet 25mg

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

Paroxetine hydrochloride hemihydrate

متاح من:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (الاسم الدولي):

Paroxetine hydrochloride hemihydrate

الوحدات في الحزمة:

30Tablet Tablets

المصنعة من قبل:

Bora Pharmaceutical Services Inc.

نشرة المعلومات

Consumer Medication Information Leaflet (RiMUP)
SEROXAT CR TABLET
Paroxetine hydrochloride hemihydrate (12.5 mg, 25mg)
1
What is in this leaflet
1.
What SEROXAT CR is used for
2.
How SEROXAT CR works
3.
Before you use SEROXAT CR
4.
How to use SEROXAT CR
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of SEROXAT
CR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
What SEROXAT CR is used for
In adults aged 18 years and over,
SEROXAT CR is used to treat:
 Depression
 A severe form of premenstrual
syndrome (premenstrual dysphoric
disorder), symptoms include
depression, severe mood changes,
irritability
 Panic attacks, including those caused
by a fear of open spaces (agoraphobia)
 Anxiety caused by situations such as
socialising or performance
These conditions can occur when the
amount of a substance called serotonin in
the brain is reduced.
How SEROXAT CR works
The active ingredient in SEROXAT CR
is paroxetine which belongs to a group of
medicines called SSRIs (selective
serotonin reuptake inhibitors).
Paroxetine works by increasing serotonin
levels in the brain.
Before you use SEROXAT CR
- When you must not use it
Do not use SEROXAT CR:

If you are allergic (hypersensitive) to
paroxetine or any other ingredients of
SEROXAT CR (see section Product
Description).

If you are taking or have recently taken
(within the last two weeks) medicines
for depression called monoamine
oxidase inhibitors (MAOIs).

If you are taking or have recently taken
(within the last two weeks) an
antibiotic called linezolid.

If you are taking or have recently taken
(within the last two weeks) a medicine
called methylthioninium chloride
(methylene blue).

If you are taking medicines called
thioridazine or pimozide (usually used
to treat schizophrenia).
If you think any of these apply to you,
don’t take SEROXAT CR until you have
checked with your doctor.
- Before you start to use it
Before you take SEROXAT CR your
doctor needs to know:
 If you have ever

خصائص المنتج

CONFIDENTIAL
[GSK logo]
SEROXAT CR
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
_SEROXAT CR_
12.5 mg tablets: Yellow, round, biconvex tablets with GSK engraved on
one side and
12.5 on the other side.
_SEROXAT CR_
25 mg tablets: Pink, round, biconvex tablets with GSK engraved on one
side and 25
on the other side.
Each
_SEROXAT _
CR (controlled release) tablet contains paroxetine hydrochloride
hemihydrate equivalent to 12.5 mg or 25 mg paroxetine free base.
CLINICAL INFORMATION
INDICATIONS
•
ADULTS
MAJOR DEPRESSIVE DISORDER:
_SEROXAT _
CR tablets are indicated for the treatment of major depressive
disorder (MDD).
PANIC DISORDER:
_SEROXAT _
CR tablets have been shown to be effective in the treatment of panic
disorder
with or without agoraphobia.
PREMENSTRUAL DYSPHORIC DISORDER:
_SEROXAT _
CR tablets are indicated for the treatment of premenstrual dysphoric
disorder
(PMDD).
Paroxetine has not been evaluated beyond 3 menstrual cycles in
controlled clinical trials for
the treatment of PMDD.
SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA:
_SEROXAT _
CR tablets have been shown to be effective in the treatment of Social
Anxiety
Disorder/Social Phobia.
The effectiveness of
_SEROXAT _
CR tablets in the long-term treatment of Social Anxiety
Disorder/Social Phobia has not been evaluated. Therefore, if
_SEROXAT _
CR tablets are to be
administered for extended periods in the treatment of Social Anxiety
Disorder/Social
CONFIDENTIAL
Phobia, the physician should periodically re-evaluate the long-term
usefulness of
_SEROXAT _
CR for the individual patient.
•
CHILDREN AND ADOLESCENTS (LESS THAN 18 YEARS)
ALL INDICATIONS:
_SEROXAT _
CR is not indicated for use in children or adolescents aged less than
18 years (
_see _
_Warnings and Precautions_
).
The efficacy of
_SEROXAT _
CR tablets has not been studied in children or adolescents aged
less than 18 years; however, controlled clinical studies with
_SEROXAT _
IR (immediate
release) tablets in children and adolescents with major depressive
disorder failed t