SEROXAT

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

PAROXETINE AS HYDROCHLORIDE

Disponível em:

GLAXO SMITH KLINE (ISRAEL) LTD

Código ATC:

N06AB05

Forma farmacêutica:

COATED TABLETS

Composição:

PAROXETINE AS HYDROCHLORIDE 20 MG

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

GLAXO SMITH KLINE PHARMACEUTICALS S.A., POLAND

Área terapêutica:

PAROXETINE

Indicações terapêuticas:

Treatment of (in adults):­ Major Depressive Disorder ­ Obsessive Compulsive Disorder (OCD)­ Panic Disorder with and without agoraphobia­ Social Anxiety Disorders/Social phobia­ Generalised Anxiety Disorder­ Post-Traumatic Stress Disorder

Data de autorização:

2016-03-02

Folheto informativo - Bula

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a physician’s prescription only
Seroxat
Film-Coated Tablets
Each film-coated tablet contains: paroxetine (as hydrochloride) 20 mg
For the list of the inactive and allergenic ingredients in the
medicine, see section
2 - “Important information about some of the ingredients in the
medicine” and
section 6 “Additional Information”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar.
Antidepressants and anti-anxiety medicines increase the risk of
suicidal
behavior and thoughts in patients up to the age of 25.
On starting treatment with the medicine, patients and their relatives
should
monitor any behavioral changes such as worsening of depression,
suicidal
thoughts, aggression, etc. If such changes should occur, refer
immediately to
the physician.
1. WHAT IS THE MEDICINE INTENDED FOR?
Seroxat is intended for treatment of adults with major/clinical
depression and/or
anxiety disorders. The anxiety disorders that Seroxat is used to treat
are:
obsessive compulsive disorder, panic disorder, social anxiety,
post-traumatic
stress disorder and generalised anxiety disorder.
Therapeutic group:
Selective serotonin reuptake inhibitors (SSRIs).
It is not fully understood how Seroxat and other selective serotonin
reuptake
inhibitors work, but they may help by increasing the level of
serotonin in the
brain. Treating depression or anxiety disorders properly is important
to help you
feel better.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
•
You are sensitive (allergic) to paroxetine or to any of the additional
ingredients contained in this medicine (listed in section 6).
•
You are taki

Características técnicas

1.
NAME OF MEDICINAL PRODUCT
Seroxat
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg paroxetine (as paroxetine
hydrochloride hemihydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, film-coated tablet, oval shaped biconvex tablets debossed with
“20” on one side and a break
bar on the other.
The 20 mg tablet can be divided into equal doses if required.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in patient under age 25 in short-
term studies. These studies did not show an increase in the risk of
suicidal thoughts and behavior with
antidepressant use in patients over age 25; there was a reduction in
risk with antidepressant use in
patients aged 65 and older.
In patients who are started on antidepressant therapy monitor closely
for clinical worsening and
emergence of suicidal thoughts and behaviors. Advise families and
caregivers of the need for close
observation and communication with the prescriber.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of (in adults):
-
Major Depressive
Disorder
-
Obsessive Compulsive Disorder (OCD)
-
Panic Disorder with and without agoraphobia
-
Social Anxiety Disorders/Social phobia
-
Generalised Anxiety Disorder
-
Post-Traumatic Stress Disorder
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
2/15
_IT IS RECOMMENDED THAT SEROXAT IS ADMINISTERED ONCE DAILY IN THE
MORNING WITH FOOD. THE TABLET _
_SHOULD BE SWALLOWED WHOLE. _
_ _
_Major depressive disorder _
The recommended dose is 20 mg daily. Some patients not responding to a
20 mg dose may benefit
from dose increases in 10 mg/day increments, up to a maximum of 50
mg/day according to the
patient's response
_ _
As with all antidepressant medicinal products, dosage should be
reviewed and adjusted if necessary
within 2 to 3 of weeks of initiation of therapy and thereafter as
judged clinically appropriate.
_ _
_ _
Patients with depression should be treated for