Paroxetine GSK 30 mg, filmomhulde tabletten

देश: नीदरलैंड

भाषा: डच

स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

सक्रिय संघटक:

PAROXETINEHYDROCHLORIDE 0,5-WATER SAMENSTELLING overeenkomend met ; ; PAROXETINE 30 mg/stuk

थमां उपलब्ध:

GlaxoSmithKline B.V. Van Asch van Wijckstraat 55H 3811 LP AMERSFOORT

ए.टी.सी कोड:

N06AB05

INN (इंटरनेशनल नाम):

PAROXETINEHYDROCHLORIDE 0,5-WATER SAMENSTELLING overeenkomend met ; ; PAROXETINE 30 mg/stuk

फार्मास्यूटिकल फॉर्म:

Filmomhulde tablet

रचना:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYETHYLEENGLYCOL (E 1521) ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171)

प्रशासन का मार्ग:

Oraal gebruik

चिकित्सीय क्षेत्र:

Paroxetine

प्राधिकरण की तारीख:

1900-01-01

सूचना पत्रक

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PAROXETINE GSK 20 MG
PAROXETINE GSK 30 MG
paroxetine (as the hydrochloride hemihydrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Paroxetine GSK is and what it is used for
2.
What you need to know before you take Paroxetine GSK
3.
How to take Paroxetine GSK
4.
Possible side effects
5.
How to store Paroxetine GSK
6.
Contents of the pack and other information
1.
WHAT PAROXETINE GSK IS AND WHAT IT IS USED FOR
PAROXETINE GSK IS A TREATMENT FOR ADULTS WITH DEPRESSION AND/OR
ANXIETY DISORDERS.
The anxiety
disorders that Paroxetine GSK is used to treat are: obsessive
compulsive disorder (repetitive, obsessive
thoughts with uncontrollable behaviour), panic disorder (panic
attacks, including those caused by
agoraphobia, which is a fear of open spaces), social anxiety disorder
(fear or avoidance of social
situations), post-traumatic stress disorder (anxiety caused by a
traumatic event) and generalised
anxiety disorder (generally feeling very anxious or nervous).
Paroxetine GSK is one of a group of medicines called SSRIs (selective
serotonin reuptake inhibitors).
It is not fully understood how Paroxetine GSK and other SSRIs 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 get better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PAROXETINE GSK
DO NOT TAKE PAROXETINE GSK
-
IF YOU ARE TAKING MEDICINES CALLED MONOAMINE OXIDASE INHIBITORS
(MAOIs, including
moc

उत्पाद विशेषताएं

1/16
1.
NAME OF MEDICINAL PRODUCT
Paroxetine GSK 20 mg, film coated tablets
Paroxetine GSK 30 mg, film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg or 30 mg paroxetine (as
paroxetine hydrochloride
hemihydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
<20 mg tablet>

<30 mg tablet>

4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of
-
Major Depressive Episode
-
Obsessive Compulsive Disorder
-
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
_Major depressive episode _
The recommended dose is 20 mg daily. In general, improvement in
patients starts after one week but
may only become evident from the second week of therapy.
As with all antidepressant medicinal products, dosage should be
reviewed and adjusted if necessary
within 3 to 4 weeks of initiation of therapy and thereafter as judged
clinically appropriate. In some
patients, with insufficient response to 20 mg, the dose may be
increased gradually up to a maximum of
50 mg a day in 10 mg steps according to the patient’s response.
_ _
_ _
Patients with depression should be treated for a sufficient period of
at least 6 months to ensure that
they are free from symptoms.
IAin833
_Obsessive compulsive disorder (OCD) _
The recommended dose is 40 mg daily. Patients should start on 20
mg/day and the dose may be
increased gradually in 10 mg increments to the recommended dose. If
after some weeks on the
recommended