Solian 400mg Film-coated Tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Amisulpride

متاح من:

PCO Manufacturing Ltd.

ATC رمز:

N05AL; N05AL05

INN (الاسم الدولي):

Amisulpride

جرعة:

400 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Benzamides; amisulpride

الوضع إذن:

Authorised

تاريخ الترخيص:

2016-12-23

نشرة المعلومات

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLIAN
® 50MG TABLETS
SOLIAN
® 100MG TABLETS
SOLIAN
® 200MG TABLETS
SOLIAN
® 400MG FILM-COATED TABLETS
Amisulpride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE

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.
IN THIS LEAFLET:
1.
What Solian is and what it is used for
2.
What you need to know before you take Solian
3.
How to take Solian
4.
Possible side effects
5.
How to store Solian
6.
Contents of the pack and other information
1.
WHAT SOLIAN IS AND WHAT IT IS USED FOR
Solian contains a medicine called amisulpride. This belongs to a group
of medicines called 'anti-psychotics'. It is used to treat an illness
called
schizophrenia. Schizophrenia can make you feel, see or hear things
which do not exist, have strange and frightening thoughts, change how
you act, and make you feel alone.
Sometimes people with these symptoms may also feel tense, anxious or
depressed. Solian works by improving disturbed thoughts, feelings and
behaviour. It is used to treat schizophrenia when it starts and also
over
the long term.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLIAN
Do not take this medicine, and tell your doctor if:
–
You are allergic (hypersensitive) to amisulpride or any of the other
ingredients of Solian (listed in Section 6). Signs of an allergic
reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face, throat or tongue.
–
You are pregnant, might become pregnant or are breast-feeding
(see ‘Pregnancy and breast-feeding’ section)
–
You have breast cancer or something called 'a prolactin dependent
tumour'
–
You have a pituitary tumour
–
You ha

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solian 400mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amisulpride 400 mg per tablet.
Also contains lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
_Product imported from the UK:_
White film-coated tablet scored and engraved ‘AMI 400’.
4 CLINICAL PARTICULARS
As per PA0540/158/004
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/158/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium Starch Glycolate
Lactose Monohydrate
Microcrystalline Cellulose
Hypromellose
Magnesium Stearate
Titanium Dioxide (E171)
Macrogol Ester
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 carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
No special precautions for storage.
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6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 60 tablets.
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 AUTHORISATION HOLDER
PCO Manufacturing
Unit 10, Ashbourne Business Park
Rath
Ashbourne