Seroxat 30mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Paroxetine hydrochloride

Disponibil de la:

Lexon (UK) Ltd

Codul ATC:

N06AB05

INN (nume internaţional):

Paroxetine hydrochloride

Dozare:

30mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04030300

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEROXAT
® 30MG FILM COATED TABLETS
(paroxetine hydrochloride)
YOUR MEDICINE IS KNOWN AS THE ABOVE BUT WILL BE REFERRED TO AS
SEROXAT THROUGHOUT THE REMAINDER OF THIS LEAFLET.
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.

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Seroxat® 30mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains paroxetine 30 mg (as paroxetine
hydrochloride
hemihydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Blue, oval shaped biconvex tablets debossed with “SEROXAT 30” or
“30” on one
side and a break bar on the other. The break bar is only to facilitate
breaking for ease
of swallowing and not to divide into equal doses.
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.
Patients with OCD should be treated for a sufficient period to ensure
that they are free from
symptoms. This p