Seroxat 20mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PAROXETINE HYDROCHLORIDE, HEMIHYDRATE

Available from:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC code:

N06AB05

INN (International Name):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2006-04-13

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SEROXAT 10 MG FILM-COATED TABLETS
SEROXAT 20 MG FILM-COATED TABLETS
SEROXAT 30 MG FILM-COATED TABLETS
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 Seroxat is and what it is used for
2.
What you need to know before you take Seroxat
3.
How to take Seroxat
4.
Possible side effects
5.
How to store Seroxat
6.
Contents of the pack and other information
1.
WHAT SEROXAT IS AND WHAT IT IS USED FOR
SEROXAT IS A TREATMENT FOR ADULTS WITH DEPRESSION AND/OR ANXIETY
DISORDERS.
The anxiety disorders
that Seroxat 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).
Seroxat is one of a group of medicines called SSRIs (selective
serotonin reuptake inhibitors). It is not
fully understood how Seroxat 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 SEROXAT
DO NOT TAKE SEROXAT
-
IF YOU ARE TAKING MEDICINES CALLED MONOAMINE OXIDASE INHIBITORS
(MAOIs, including
moclobemide and met

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF MEDICINAL PRODUCT
SEROXAT 20 mg 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.
White, film-coated tablet, oval shaped biconvex tablets debossed with
“SEROXAT 20” or “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 (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 dose insufficient response is seen some patients may
benefit from having their dose
increased gradually up to a maximum of 60 mg/day.
Patients with OCD should be treated for a sufficient period to ensure
that they are free from
symptoms. This perio