SEROXAT TABLET 20 mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Paroxetine Hydrochloride Hemihydrate 22.8 mg eqv paroxetine

Tilgængelig fra:

GLAXOSMITHKLINE PTE LTD

ATC-kode:

N06AB05

Dosering:

20 mg

Lægemiddelform:

TABLET, FILM COATED

Sammensætning:

Paroxetine Hydrochloride Hemihydrate 22.8 mg eqv paroxetine 20 mg

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

GlaxoSmithKline Pharmaceuticals S.A.

Autorisation status:

ACTIVE

Autorisation dato:

1992-06-09

Indlægsseddel

 
1 

SEROXAT
 
PAROXETINE HYDROCHLORIDE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains paroxetine hydrochloride equivalent
to 20 mg paroxetine free base. 
PHARMACEUTICAL FORM 
_20 mg tablets:_

White, film-coated, oval-shaped biconvex tablet debossed
with ‘20’ on one 
side and a break bar on the other. 
CLINICAL PARTICULARS 
INDICATIONS 
ADULTS 
DEPRESSION: 
Treatment of symptoms of depressive illness of all types
including reactive and severe 
depression and depression
accompanied by anxiety. Following an initial satisfactory 
response, continuation with _SEROXAT_ therapy is effective
in preventing relapse of 
Depression. 
ANXIETY DISORDERS: 
Treatment of symptoms and prevention of relapse of Obsessive
Compulsive Disorder (OCD). 
Treatment of symptoms and prevention of relapse of Panic
Disorder With or Without 
Agoraphobia. 
Treatment of Social Anxiety Disorder/Social Phobia.  
Treatment of symptoms and prevention of relapse of Generalised
Anxiety Disorder. 
Treatment of Post-Traumatic Stress Disorder. 
CHILDREN AND ADOLESCENTS (LESS THAN 18 YEARS) 
ALL INDICATIONS: 
_SEROXAT_ is not indicated for use in children or
adolescents aged less than 18 years (_see _
_Warnings and Precautions_). 
Controlled clinical studies in children and adolescents with
major depressive disorder failed 
to demonstrate efficacy, and do not
support the use of _SEROXAT_ in the treatment of 
depression in this population_ _(_see
Warnings and Precautions_). 
The safety and efficacy of _SEROXAT_ in children aged less
than 7 years has not been studied. 

2 
DOSAGE AND ADMINISTRATION 
ADULTS 
For oral administration. 
It is recommended that _SEROXAT_ be administered once
daily in the morning with food. 
The tablets should be swallowed rather than chewed. 
As with all antidepressant drugs, dosage should be reviewed and
adjusted if�

Produktets egenskaber

1
SEROXAT
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
_SEROXAT_
20 mg tablets: White, film-coated, oval shaped, biconvex tablets with
a break
line on one side.
Each
_SEROXAT _
tablet contains paroxetine hydrochloride hemihydrate equivalent to 20
mg paroxetine free base.
CLINICAL INFORMATION
INDICATIONS
ADULTS
MAJOR DEPRESSIVE DISORDER:
_SEROXAT_
is indicated for the treatment of major depressive disorder (MDD).
Results of studies in which patients received
_SEROXAT_
treatment for up to one year
indicate that
_SEROXAT_
is effective in preventing the relapse of depressive symptoms.
ANXIETY DISORDERS:
Treatment of symptoms and prevention of relapse of Obsessive
Compulsive Disorder
(OCD).
Treatment of symptoms and prevention of relapse of Panic Disorder With
or Without
Agoraphobia.
Treatment of Social Anxiety Disorder/Social Phobia.
Treatment of symptoms and prevention of relapse of Generalised Anxiety
Disorder.
Treatment of Post-Traumatic Stress Disorder.
CHILDREN AND ADOLESCENTS (LESS THAN 18 YEARS)
ALL INDICATIONS:
_SEROXAT_
is not indicated for use in children or adolescents aged less than 18
years (
_see _
_Warnings and Precautions_
).
Controlled clinical studies in children and adolescents with major
depressive disorder
failed to demonstrate efficacy, and do not support the use of
_SEROXAT_
in the treatment
of depression in this population
_ _
(
_see Warnings and Precautions_
).
2
The safety and efficacy of
_SEROXAT_
in children aged less than 7 years has not been
studied.
DOSAGE AND ADMINISTRATION
Pharmaceutical form: film-coated tablet
ADULTS
For oral administration.
It is recommended that
_SEROXAT_
be administered once daily in the morning with food.
Tablets:
_ _
The tablets should be swallowed rather than chewed. The 20 mg tablets
have
functional break lines to allow for breaking the tablets in half to
yield 10 mg doses if
needed.
As with all antidepressant drugs, dosage should be reviewed and
adjusted if necessary
within 2 to 3 weeks of initiation of therapy and thereafter