SEROXAT 20 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Available from:

LTT Pharma Limited

ATC code:

N06AB05

INN (International Name):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Dosage:

20 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

Selective serotonin reuptake inhibitors

Authorization status:

Authorised

Authorization date:

2011-08-05

Patient Information leaflet

SEROXAT 20MG FILM-COATED TABLETS
PATIENT INFORMATION 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:
What Seroxat is and what it is used for
What you need to know before you take ‘Seroxat’
How to take Seroxat
Possible side effects
How to store Seroxat
Contents of the pack and other information
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.
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 ch

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE 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.
_Product imported from the UK:_
White, film-coated oval tablets, debossed with “SEROXAT 20” or “20” on one side and a break bar on the other.
The 20mg film-coated tablet has a break-line and can be divided into equal halves if required.
4 CLINICAL PARTICULARS
As per PA1077/097/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/097/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Dibasic calcium phosphate dihydrate (E341)
Magnesium sterate (E470b)
Sodium starch glycolate (Type A)
Tablet coating:
Hypromellose (E464)
Titanium dioxide (E171)
Macgrogol 400
Polysorbate 80 (E433)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on
the market in the country of origin.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 13/07/2016_
_CRN 2176185_
_page number: 1_
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30ºC.
Store in the original package in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs comprising opaque PVC/PVdC or opaque polyvinyl chloride (PVC) backed with aluminium foil. Pack
size: 30
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements
7 PARALLEL PRODUCT AUTHORISATI