Solian 200 tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Amisulpride

Tilgjengelig fra:

Waymade Healthcare Plc

ATC-kode:

N05AL05

INN (International Name):

Amisulpride

Dosering :

200mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04020100

Informasjon til brukeren

SOLIAN
®
200 MG TABLETS
SOLIAN
®
400 MG TABLETS
(amisulpride)
PATIENT INFORMATION 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. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is available using the above name but will be referred
to as
Solian throughout this leaflet. This medicine is also available in
other
strengths.
IN THIS LEAFLET:
1. What Solian is and what it is used for
2. Before you take Solian
3. How to take Solian
4. Possible side effects
5. How to store Solian
6. Further 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. 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 have breast cancer or something called ‘a prolactin dependent
tumour’
- You have a tumour on the adrenal gland (called phaeochromocytoma)
- You are taking levodopa, a medicine to treat Parkinson’s disease
(see
‘Taking

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Solian 200mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of the active substance, amisulpride
Also contains 139.2mg of lactose monohydrate
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat-faced, breakable tablet engraved AMI
200 on
one face and with a breakable bar on the other face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Solian 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d
are
recommended. In individual cases, the daily dose may be increased up
to 1200 mg/d.
Doses above 1200 mg/d have not been extensively evaluated for safety
and therefore
should not be used. No specific titration is required when initiating
the treatment with
Solian. 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, oral
doses between 50
mg/d and 300 mg/d are recommended. Doses should be adjusted
individually.
Solian can be administered once daily at oral doses up to 300 mg,
higher doses should
be administered bid.
The minimum effective dose should be used.
Elderly: The safety of amisulpride has been examined in a limited
number of elderly
patients. Amisulpride should be used with particular caution because
of a possible
risk of hypotension and sedation. Reduction in dosage may also be
required because
of r