Seroxat 20mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PAROXETINE

Available from:

Smithkline Beecham Limited

ATC code:

N06AB05

INN (International Name):

PAROXETINE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PAROXETINE 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 20 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).
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 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
3.
DO NOT TAKE SEROXAT...
-
IF YOU ARE TAKING M

Summary of Product characteristics

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 18
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.
Oral suspension.
20 mg tablet
White, film-coated tablet, oval shaped biconvex tablets debossed with
“SEROXAT
20”,
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.
Page 3 of 18
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.
Patients with OCD should be treated for a sufficient period to ensure
that they are free from
symptoms. This period may be several m