Amisulpride 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amisulpride

Available from:

DE Pharmaceuticals

ATC code:

N05AL05

INN (International Name):

Amisulpride

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100

Patient Information leaflet

SOLIAN
®
100 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 other medicines’ sectio

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amisulpride 100 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of amisulpride
_ _
Excipient with known effect
Each tablet contains 47.50 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, round, flat, 8 mm in diameter, with a score line. The tablet
can be divided into
equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amisulpride is indicated for the treatment of acute and chronic
schizophrenic
disorders with:
-
positive symptoms such as delusions, hallucinations, thought
disorders,
hostility, suspiciousness
-
negative symptoms (deficit syndrome) such as blunted affect, emotional
and social withdrawal.
This includes patients with predominant negative symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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. 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 with amisulpride. 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 in example
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/day and 300 mg/day are recommended. Doses should be
adjusted individually.
Amisulpride can be administered once daily at oral doses up to 300 mg,
higher
doses should be administered bid.
The minimum effective dose and appropriate strength tablets should be
used.
Special populations
_Elderly (over 65 years):_ The safety of amisulpride has been examined
in a
limited number of elderly patients. Amisu