Amisulpride 50mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Amisulpride

Commercializzato da:

Dowelhurst 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

Foglio illustrativo

LOGO ACCORD
AMISULPRIDE 50MG, 100MG, AND 200MG TABLETS
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, PHARMACIST OR
NURSE.
•
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET: _ _
1.
WHAT AMISULPRIDE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMISULPRIDE TABLETS
3.
HOW TO TAKE AMISULPRIDE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE AMISULPRIDE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT AMISULPRIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Amisulpride tablets
contain the active substance amisulpride which belong to a group of
medicines called benzamide
antipsychotics. These work by improving thoughts, feelings and/or
behaviour when these are disturbed
in certain medical conditions.
Amisulpride tablets may be used in the treatment of acute (severe or
sudden) and chronic (ongoing or
long-term) schizophrenia, a condition where certain symptoms become
very noticeable. These include
feeling, hearing or seeing things that aren’t really there
(hallucinations), having a strong false belief
despite evidence against it (delusions), inability to think normally,
and feeling emotional, disinterested
or withdrawn.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMISULPRIDE TABLETS
DO NOT TAKE AMISULPRIDE TABLETS IF YOU:
•
are
BREASTFEEDING
•
are allergic to amisulpride or any of the other ingredients of this
medicine (listed in section 6) have
a
TUMOUR
that depends on prolactin (a hormone produced by the pituitary gland)
or
BREAST CANCER
•
have
PHAEOCHROMOCYTOMA
(a tumour of the adrenal gland causing high blood pressure)
�

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amisulpride 50mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg amisulpride.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, round, flat-faced tablet, engraved AMI 50 on one
side.
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
age of 18
years have not been est