Solian 100mg Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Amisulpride

Verfügbar ab:

Imbat Limited

ATC-Code:

N05AL; N05AL05

INN (Internationale Bezeichnung):

Amisulpride

Dosierung:

100 milligram(s)

Darreichungsform:

Tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Benzamides; amisulpride

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2013-10-04

Gebrauchsinformation

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLIAN
® 100MG TABLETS
(amisulpride)
Your medicine is available using the name Solian 100mg Tablets
but will be referred to as Solian throughout this leaflet.
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 ‘antipsychotics’.
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 breastfeeding’ section)

You have breast cancer or something called ‘a prolactin
dependent tu

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solian 100mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amisulpride 100mg per tablet
Also contains lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
_Product imported from UK:_
White to off white, round, flat-faced breakable tablets engraved with
‘AMI 100’ on one face and with a breakline on
the other.
The score line / break line is only to facilitate breaking for ease of
swallowing and not to divide into equal doses
4 CLINICAL PARTICULARS
As per PA0540/158/002.
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/158/002.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium Starch Glycolate
Lactose Monohydrate
Microcrystalline Cellulose
Hypromellose
Magnesium Stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the inner and outer packaging of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
No special precautions for storage.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips of 10 tablets contained in an outer carton.
Pack size: 60 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT