Paroxetine 20 mg tablet GSK, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

PAROXETINE HYDROCHLORIDE 0,5-WATER SAMENSTELLING overeenkomend met; PAROXETINE;

Beschikbaar vanaf:

GlaxoSmithKline B.V.

ATC-code:

N06AB05

INN (Algemene Internationale Benaming):

PAROXETINE HYDROCHLORIDE 0,5-WATER COMPOSITION corresponding to; PAROXETINE;

farmaceutische vorm:

Filmomhulde tablet

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Paroxetine

Product samenvatting:

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

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
PAROXETINE 20 MG TABLET GSK
filmomhulde tabletten
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 20 mg tablet GSK is and what it is used for
2.
What you need to know before you take Paroxetine 20 mg tablet GSK
3.
How to take Paroxetine 20 mg tablet GSK
4.
Possible side effects
5.
How to store Paroxetine 20 mg tablet GSK
6.
Contents of the pack and other information
1.
WHAT PAROXETINE 20 MG TABLET GSK IS AND WHAT IT IS USED FOR
PAROXETINE 20 MG TABLET GSK IS A TREATMENT FOR ADULTS WITH DEPRESSION
AND/OR ANXIETY DISORDERS.
The anxiety disorders that Paroxetine 20 mg tablet 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 20 mg tablet GSK is one of a group of medicines called
SSRIs (selective serotonin
reuptake inhibitors). Everyone has a substance called serotonin in
their brain. People who are
depressed or anxious have lower levels of serotonin than others. It is
not fully understood how
Paroxetine 20 mg tablet GSK and other SSRIs work but they may help by
increasing the level of
serotonin in th

Productkenmerken

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1.
NAME OF MEDICINAL PRODUCT
Paroxetine 20 mg GSK, film coated tablets.
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.
20 mg 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.
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.
OBSESSIVE COMPULSIVE DISORDER
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 dose insufficient response is seen some patients may
benefit from having their dose
increased gradually up to a maximum of 60 mg/day.
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Patients with OCD should be treated for a sufficient period to ensure
that they are free from
symptoms. This period may be several months or even longer (