Amisulpride 200mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Amisulpride

Disponibil de la:

Arrow Generics Ltd

Codul ATC:

N05AL05

INN (nume internaţional):

Amisulpride

Dozare:

200mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04020100; GTIN: 5060034832805

Prospect

_PACKAGE LEAFLET: INFORMATION FOR THE USER_
_AMISULPRIDE 50MG, 100MG, 200MG AND 400MG TABLETS_
(Amisulpride)
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.
_1. WHAT AMISULPRIDE TABLETS ARE AND WHAT THEY ARE USED FOR_
Amisulpride belongs to a group of medicines called antipsychotics
which help to control the symptoms
of a mental illness called schizophrenia.
Amisulpride Tablets can be used at the start of and for the long term
treatment of schizophrenia.
Symptoms include:
- delusions (having strange or unusual thoughts)
- hallucinations (seeing or hearing things that are not there)
- being suspicious or aggressive for no apparent reason
(these symptoms are known as "positive symptoms")
- becoming withdrawn and subdued (known as "negative symptoms").
_2. BEFORE YOU TAKE AMISULPRIDE TABLETS _
DO NOT TAKE AMISULPRIDE TABLETS:
• if you are allergic (hypersensitive) to amisulpride
• if you are allergic to any of the other ingredients of Amisulpride
Tablets
(see section 6 – Further information)
• if you are breast-feeding
• if you have breast cancer or a tumour of the pituitary gland
• if you have a tumour on the adrenal gland (known as
phaeochromocytoma)
• if you are under 18 years of age
• if you have severe kidney disease
• if you are taking levodopa (for Parkinson's disease), medicines to
treat heart rhythm disorders, or
medicines that may cause an abnormal heart rhythm when used at the
same time as amisulpride.
See the section "Taking other medicines" below.
Check with your doctor before taking any other medicine.
TAKE SPECIAL CARE WITH AMISULPRIDE TABLETS:
You should t

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amisulpride 200mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg amisulpride.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, round, flat-faced tablet engraved AMI 200 on one
side and
a breakline on the other.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Amisulpride 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 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.
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.
Amisulpride 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
ag