Solian 50mg Tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Amisulpride

Disponible des:

Sanofi-Aventis Ireland Limited T/A SANOFI

Codi ATC:

N05AL; N05AL05

Designació comuna internacional (DCI):

Amisulpride

Dosis:

50 milligram(s)

formulario farmacéutico:

Tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Benzamides; amisulpride

Estat d'Autorització:

Marketed

Data d'autorització:

1998-07-27

Informació per a l'usuari

SOLIAN 50MG TABLETS
SOLIAN 100MG TABLETS
SOLIAN 200MG TABLETS
SOLIAN 400MG FILM-COATED TABLETS
Amisulpride
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP
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 or might become pregnant (see 'Pregnancy and
breast-feeding section)
× You have breast cancer or something called ‘a prolactin dependent
tumour’
× You have a pituitary tumour
× You have a tumour on the adr

Fitxa tècnica

Health Products Regulatory Authority
25 August 2022
CRN00CQGT
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solian 50mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amisulpride 50 mg per tablet.
Also contains lactose monohydrate 34.8mg per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white round flat faced tablet engraved ‘AMI 50’ on
one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amisulpride is indicated for the treatment of acute and chronic
schizophrenic disorders, in which positive symptoms (such as
delusions, hallucinations, thought disorders) and/or negative symptoms
(such as blunted affect, emotional and social
withdrawal) are prominent, including patients characterised by
predominant negative symptoms.
Amisulpride also regulates secondary negative symptoms in productive
state, as well as affective disorders such as depressive
mood.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For acute psychotic episodes, oral doses between 400 mg/day and 800
mg/day are recommended. In individual cases, the daily
dose may be increased up to 1200 mg/day. Doses above 1200 mg/day have
not been extensively evaluated for safety and
therefore should not be used. No specific titration is required when
initiating the treatment. Doses should be adjusted
according to individual response.
For patients with mixed positive and negative symptoms, doses should
be adjusted to obtain optimal control of positive
symptoms.
Maintenance treatment should be established individually with the
minimally effective dose.
For patients characterised by predominant negative symptoms (deficit
syndrome), oral doses between 50 mg/day and 300
mg/day are recommended. Doses should be adjusted individually.
Amisulpride can be administered once a day at oral doses up to 400mg,
higher dose should be split into two separate doses.
Elderly: The safety of amisulpride has been examined in a limited
number of elderly patients. Amisulpride should be used with
pa