SOLIAN 200 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi-Aventis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS AMISULPRIDE 200,0 mg

Authorization status:

Registered

Authorization date:

2002-03-06

Patient Information leaflet

_ _
_ _
_ _
sanofi-aventis south africa (pty) ltd
Solian 50 mg & 200 mg (Tablets)
50 mg or 200 mg amisulpride per tablet
DATE OF APPROVAL: 31 March 2023
Page 1 of 13
PATIENT INFORMATION LEAFLET FOR SOLIAN
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S5
SOLIAN
® 50 MG TABLETS
SOLIAN
® 200 MG TABLETS
AMISULPRIDE
CONTAINS SUGAR:
SOLIAN 50 mg: Each tablet contains 34,80 mg lactose monohydrate.
SOLIAN 200 mg: Each tablet contains 139,20 mg lactose monohydrate.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING SOLIAN.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
SOLIAN has been prescribed for you personally and you should not share
your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS 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.
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_ _
_ _
sanofi-aventis south africa (pty) ltd
Solian 50 mg & 200 mg (Tablets)
50 mg or 200 mg amisulpride per tablet
DATE OF APPROVAL: 31 March 2023
Page 2 of 13
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 a mental illness called
schizophrenia.
Schizophrenia can make you feel, see or hear things which do not
exist, have strange and
frightening thought(s), be suspicious or aggressive for no apparent
reason, 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 behaviours. 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 SOLIAN IF:
•
you are allergic (hypersensitive) to amisulpride or to any of the
other ingredients

Summary of Product characteristics

_ _
_ _
_ _
sanofi-aventis south africa (pty) ltd
Solian 50 mg & 200 mg (Tablets)
50 mg or 200 mg amisulpride per tablet
DATE OF APPROVAL: 31 March 2023
Page 1 of 17
PROFESSIONAL INFORMATION FOR SOLIAN
SCHEDULING STATUS
S5
1.
NAME OF THE MEDICINE
SOLIAN
® 50 MG tablets
SOLIAN
® 200 MG tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SOLIAN 50 MG: Each tablet contains 50 mg amisulpride.
SOLIAN 200 MG: Each tablet contains 200 mg amisulpride.
EXCIPIENTS WITH KNOWN EFFECT
SOLIAN 50 MG:
Contains sugar (lactose monohydrate): 34,80 mg per tablet.
SOLIAN 200 MG:
Contains sugar (lactose monohydrate): 139,20 mg per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
SOLIAN 50 MG:
Round, white to off-white, flat-faced tablet, engraved AMI 50 on one
face of the tablet.
SOLIAN 200 MG:
Round, white to off-white, flat-faced, breakable tablet, engraved AMI
200 on one face and with a
breakable bar on the other face of the tablet.
_ _
_ _
_ _
sanofi-aventis south africa (pty) ltd
Solian 50 mg & 200 mg (Tablets)
50 mg or 200 mg amisulpride per tablet
DATE OF APPROVAL: 31 March 2023
Page 2 of 17
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SOLIAN is indicated for the treatment of patients with acute and
chronic schizophrenia, including
patients characterised by predominant negative symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
No specific titration is required when initiating the treatment with
SOLIAN and doses should be
adjusted according to the individual response.
SOLIAN can be administered once daily at oral doses up to 400 mg,
higher doses should be
administered twice daily.
The minimum effective dose should be used.
_ADULTS _
_For acute schizophrenia: _
Oral doses between 400 – 800 mg/day are recommended. In individual
cases, the dose may be
increased up to 1 200 mg/day. Doses above 1 200 mg/day have not been
evaluated for safety and
therefore should not be used.
_For patients with mixed positive and negative symptoms: _
Doses should be adjusted to obtain opti