Seroxat CR Tablet 12.5mg

Land: Maleisië

Taal: Engels

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

Werkstoffen:

Paroxetine hydrochloride hemihydrate

Beschikbaar vanaf:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Algemene Internationale Benaming):

Paroxetine hydrochloride hemihydrate

Eenheden in pakket:

30Tablet Tablets

Geproduceerd door:

GLAXOSMITHKLINE INC.

Bijsluiter

_ _
_ _
_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

Productkenmerken

CONFIDENTIAL
[GSK logo]
SEROXAT CR
Paroxetine hydrochloride hemihydrate
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each SEROXAT CR (controlled release) tablet contains paroxetine hydrochloride
hemihydrate equivalent to 12.5 mg or 25 mg paroxetine free base.
PHARMACEUTICAL FORM
12.5 mg tablets: Yellow, round, biconvex tablets with GSK engraved on one side and
12.5 on the other side.
25 mg tablets: Pink, round, biconvex tablets with GSK engraved on one side and 25 on the
other side.
CLINICAL PARTICULARS
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.