Solian 100 tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Amisulpride

Διαθέσιμο από:

Sanofi

Φαρμακολογική κατηγορία (ATC):

N05AL05

INN (Διεθνής Όνομα):

Amisulpride

Δοσολογία:

100mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04020100; GTIN: 5000283609766

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLIAN 50MG TABLETS
SOLIAN 100MG TABLETS
SOLIAN 200MG TABLETS
SOLIAN 400MG FILM-COATED TABLETS
Amisulpride
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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 other
s. It ma
y 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.
IN THIS LEAFLET:
1. What Solian is and what it is used for
2. Before you take Solian
3. How to take Solian
4. P
ossible side ef
fects
5. How to store Solian
6. Further Inf
orma
tion
1. WHA
T SOLIAN IS AND WHAT IT IS
USED F
OR
Solian contains a medicine called amisulpride.
This belongs to a g
roup 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 other
medicin

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Solian 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg of the active substance, amisulpride
Also contains 69.6mg 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
100 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 re