SEROXAT

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Available from:

PCO Manufacturing

ATC code:

N06AB05

INN (International Name):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Dosage:

30 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

paroxetine

Authorization status:

Authorised

Authorization date:

1999-08-23

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SEROXAT
®
20MG FILM-COATED TABLETS
SEROXAT
®
30MG 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

Summary of Product characteristics

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 30 mg paroxetine (as hydrochloride
hemihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Greee. The Netherlands and the UK:_
Blue, oval, film coated tablets engraved ‘Seroxat 30’ on one side
and having a breakline on the reverse.
4 CLINICAL PARTICULARS
As per PA1077/097/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/097/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core
Dibasic calcium phosphate dihydrate
Magnesium stearate
Sodium starch glycolate (Type A)
Tablet coating
Hypromellose
Macrogol 400
Polysorbate 80
Titanium dioxide (E171)
Indigo carmine aluminium lake (E132)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Store in the original package to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 30 tablets in an overlabelled outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED M