SEROXAT CR TABLET 25 mg

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

Paroxetine HCl Hemihydrate 28.51mg equv. to Paroxetin HCl

Dostupné s:

GLAXOSMITHKLINE PTE LTD

ATC kód:

N06AB05

Dávkování:

25mg

Léková forma:

TABLET, EXTENDED RELEASE

Složení:

Paroxetine HCl Hemihydrate 28.51mg equv. to Paroxetin HCl 25mg

Podání:

ORAL

Druh předpisu:

Prescription Only

Výrobce:

Bora Pharmaceutical Services Inc.

Stav Autorizace:

ACTIVE

Datum autorizace:

2004-08-30

Informace pro uživatele

 
1 

 SEROXAT™ CR 
PAROXETINE HYDROCHLORIDE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_SEROXAT_ CR tablets
12.5 mg and 25 mg contain paroxetine hydrochloride equivalent
to 
12.5 mg and 25 mg paroxetine free base, respectively. 

PHARMACEUTICAL FORM 
_12.5 mg tablets:_ Yellow, with GSK engraved
on one side and 12.5 on the other side. 
_25 mg tablets:_ Pink, 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. 
_SEROXAT_ CR has not been systematically evaluated beyond 12 weeks
in controlled 
clinical trials and the physician who elects to
use _SEROXAT_ CR for extended periods 
should periodically re-evaluate the long-term usefulness of the
drug for the individual 
patients. 
PREMENSTRUAL DYSPHORIC DISORDER: 
_SEROXAT_ CR tablets are indicated for the
treatment of premenstrual dysphoric disorder 
(PMDD). 
The effectiveness of _SEROXAT_ CR in long-term use, i.e. for
more than 3 menstrual 
cycles, has not been
systematically evaluated in controlled trials. Therefore, the
physician 
who elects to use _SEROXAT_ CR for extended periods should
periodically re-evaluate the 
long-term usefulness of the drug for the individual patient._  _
SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA: 
_SEROXAT_ CR Tablets are indicated for the treatment of Social
Anxiety Disorder, also 
known as Social Phobia.  
The effectiveness of _SEROXAT_ CR tablets in the
long-term treatment of Social Anxiety 
Disorder/Social Phobia, i.e. for more than 12 weeks, has not been
evaluated in adequate 
and well-controlled trials. Therefore, the physician who
elects to prescribe _SEROXAT_ CR 

2 
for extended periods should
periodically re-evaluate the long-term usefulness of the drug 
for the ind

Charakteristika produktu

1 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
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).
_SEROXAT_
CR has not been systematically evaluated beyond 12 weeks in controlled
clinical trials and the physician who elects to use
_SEROXAT_
CR for extended periods
should periodically re-evaluate the long-term usefulness of the drug
for the individual
patients.
PREMENSTRUAL DYSPHORIC DISORDER:
_SEROXAT_
CR tablets are indicated for the treatment of premenstrual dysphoric
disorder
(PMDD).
The effectiveness of
_SEROXAT_
CR in long-term use, i.e. for more than 3 menstrual
cycles, has not been systematically evaluated in controlled trials.
Therefore, the physician
who elects to use
_SEROXAT_
CR for extended periods should periodically re-evaluate the
long-term usefulness of the drug for the individual patient.
_ _
SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA:
_SEROXAT_
CR tablets are indicated for the treatment of Social Anxiety Disorder,
also
known as Social Phobia.
The effectiveness of
_SEROXAT_
CR tablets in the long-term treatment of Social Anxiety
Disorder/Social Phobia, i.e. for more than 12 weeks, has not been
evaluated in adequate
and well-controlled trials. Therefore, the physician who elects to
prescribe
_SEROXAT_
CR
2
for extended periods should periodically re-evaluate the long-term
usefulness of the drug
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 Prec