Amisulpride 50mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Amisulpride

Commercializzato da:

Viatris UK Healthcare Ltd

Codice ATC:

N05AL05

INN (Nome Internazionale):

Amisulpride

Dosaggio:

50mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04020100; GTIN: 5016695301174

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1/2
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Myriad Pro
9 pt
9 pt
170 x 480 mm
Amisulpride 400 mg,50 mg,100 mg 60
Leaflet
2198057
2096107
2198057
PL 04569/1508 PL
04569/1509
PL04569/1511
N/A
LT1934AF
850
400525914, 400525915
400525916, 400525917
552740
1
United Kingdom
N/A
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N/A
Black
21:14
10 Jun 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMISULPRIDE 50 MG,
100 MG, 200 MG
TABLETS
AMISULPRIDE 400 MG
FILM‑COATED TABLETS
amisulpride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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 only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Amisulpride is and what it is used for
2.
What you need to know before you take
Amisulpride
3.
How to take Amisulpride
4.
Possible side effects
5.
How to store Amisulpride
6.
Contents of the pack and other information
1. WHAT AMISULPRIDE IS AND WHAT IT IS
USED FOR
Amisulpride Tablets contain amisulpride
and belongs to a group of medicines called
antipsychotics which help to control the symptoms
of a mental illness called 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 are so

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amisulpride 50 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg amisulpride.
Excipient with known effect:
Each tablet contains 16.28 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White round tablet with ‘AA 50’ on one side and ‘G’ on the
reverse, 6 mm in diameter.
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), and/or
•
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
_Positive symptoms: _
For acute psychotic episodes, a daily dose between 400 mg and 800 mg
is 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 treatment. 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.
_Predominant negative symptoms (deficit syndrome) _
A daily dose between 50 mg and 300 mg is recommended. Doses should be
adjusted individually.
Amisulpride can be administered once daily at doses up to 300 mg,
higher doses should be
administered twice daily.
The minimum effective dose should be used.
_Special populations _
_Elderly patients over 65 years _
Treatment of elderly patients is not recommended. The safety of
amisulpride has been examined in a
limited number of elderly patients. If treatment with amisulpride is
ab