Seroxat 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paroxetine hydrochloride

Available from:

Waymade Healthcare Plc

ATC code:

N06AB05

INN (International Name):

Paroxetine hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300

Patient Information leaflet

SEROXAT
PAROXETINE
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
DO NOT TAKE SEROXAT
•
IF YOU ARE TAKING MEDICINES CALLED
MONOAMINE OXIDASE INHIBITORS
(MAOIs, including moclobemide and
methylthioninium chloride (methylene
blue

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Seroxat® 10mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains paroxetine 10 mg (as paroxetine
hydrochloride
hemihydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
White to pinkish-white, film-coated, oval tablets, debossed FC1 and
break bar on one
side and debossed GS and break bar on the other side.
The 10 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.
Patients with OCD should be treated for a sufficient period to ensure
that they are free from
symptoms. This period may be several m