Seroxat 20 mg Film-coated Tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Paroxetine hydrochloride hemihydrate

थमां उपलब्ध:

Imbat Limited

ए.टी.सी कोड:

N06AB; N06AB05

INN (इंटरनेशनल नाम):

Paroxetine hydrochloride hemihydrate

डोज़:

20 milligram(s)

फार्मास्यूटिकल फॉर्म:

Film-coated tablet

प्रिस्क्रिप्शन प्रकार:

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

चिकित्सीय क्षेत्र:

Selective serotonin reuptake inhibitors; paroxetine

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2007-11-09

सूचना पत्रक

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEROXAT
®
20MG FILM-COATED TABLETS
(paroxetine (as 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
DO NOT TAKE SEROXAT:

IF YOU ARE TAKING

उत्पाद विशेषताएं

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 hydrochloride
hemihydrate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK:_
White, oval shaped biconvex tablets debossed with “20” on one side
and a break bar on the other.
The 20 mg film-coated tablet has a break-line, and can be divided into
equal halves if required.
4 CLINICAL PARTICULARS
As per PA 1077/097/002
5 PHARMACOLOGICAL PROPERTIES
As per PA 1077/097/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Dibasic calcium phosphate dihydrate
Magnesium stearate
Sodium starch glycolate
Hypromellose
Titanium dioxide (E171)
Macrogol
Polysorbate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Store in the original package (to protect from light).
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6.5 NATURE AND CONTENTS OF CONTAINER
Blister foil packs in a cardboard carton.
Pack size: 30 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL