Solian 100mg/ml oral solution

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Amisulpride

Tillgänglig från:

Sanofi

ATC-kod:

N05AL05

INN (International namn):

Amisulpride

Dos:

100mg/1ml

Läkemedelsform:

Oral solution

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04020100; GTIN: 5000283609186

Bipacksedel

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303268 - 268
PACKAGE LEAFLET:
INFORMATION FOR THE USER
SOLIAN 100MG/ML SOLUTION
Amisulpride
Is this leafl et hard to see or read?
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READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE
• Keep this leafl et. 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 eff ects get serious, or if you notice
any side eff ects not listed in this leafl et, please tell
your doctor or pharmacist.
IN THIS LEAFL ET:
1. What Solian Solution is and what it is used for
2. Before you take Solian Solution
3. How to take Solian Solution
4. Possible side eff ects
5. How to store Solian Solution
6. Further information
1. WHAT SOLIAN SOLUTION IS AND WHAT IT
IS USED FOR
The name of your medicine is Solian 100mg/ml
Solution (called Solian Solution throughout this
leafl et). Solian Solution 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 Solution
works by improving disturbed thoughts, feelings
and behaviour. It is used to treat schizophrenia
when it starts and also over the long term.
OTHER SIDE EFF ECTS INCLUDE:
Common (may aff ect up to 1 in 10 people)
• Diffi culty sleeping (insomnia) or feeling anxious or
agitated
• Feeling drowsy or sleepy
• Constipation, feeling or being sick, dry mouth
• Putting on weight
• Unusual production of breast milk in women and
men, breast pain
• Menstrual period stops
• Breast enlargement in men
• Diffi culty in getting or maintaining an erection, or
in ejaculating
• Feeling dizzy (

Produktens egenskaper

OBJECT 1
SOLIAN SOLUTION 100MG/ML
Summary of Product Characteristics Updated 08-Dec-2017 | SANOFI
1. Name of the medicinal product
Solian® Solution, 100mg/ml
2. Qualitative and quantitative composition
Amisulpride 100 mg/ml
For excipients, see 6.1.
3. Pharmaceutical form
Oral Solution
A clear yellow liquid in appearance
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 i.e. between 400-800mg/day.
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 renal
insufficiency.
CHILDREN: The efficacy and safety of amisulpride from puberty to the
age o