AMISULPRIDE MYLAN

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

AMISULPRIDE

Saatavilla:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC-koodi:

N05AL05

INN (Kansainvälinen yleisnimi):

AMISULPRIDE

Annos:

200 Milligram

Lääkemuoto:

Tablets

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

amisulpride

Valtuutuksen tilan:

Not Marketed

Valtuutus päivämäärä:

2009-08-28

Pakkausseloste

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Amisulpride Mylan 50 mg and 200 mg 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 Mylan is and what it is used for
2.
What you need to know before you take Amisulpride Mylan
3.
How to take Amisulpride Mylan
4.
Possible side effects
5.
How to store Amisulpride Mylan
6.
Contents of the pack and other information
1.
WHAT AMISULPRIDE MYLAN IS AND WHAT IT IS USED FOR
Amisulpride Mylan contains a medicine called amisulpride. This belongs
to a group of medicines called
‘antipsychotics’. It is used in the treatment of acute and chronic
schizophrenic disorders. This condition
causes symptoms such as becoming withdrawn, sensing, seeing or hearing
things which do not exist,
mistaken beliefs or unfounded suspicions. Sometimes people with these
symptoms may also feel tense,
anxious or depressed.
Amisulpride Mylan also acts on mood disorder in the sense of
depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMISULPRIDE MYLAN
DO NOT TAKE AMISULPRIDE MYLAN
-
if you are allergic to amisulpride or any of the other ingredients of
this medicine (listed in section 6)
-
if you notice signs of an allergic reaction including: a rash,
swallowing or breathing problems,
swelling of your lips, face, throat or tongue
-
if you have a prolactin dependent tumour or breast cancer
-
if you have phaeochromocytoma (a tumour on the adrenal gland)
-
if you are breast-feeding (see Pregnancy and breast-feeding section)
- if you are

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amisulpride Mylan 200 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg amisulpride.
Excipient with known effect:
Each tablet contains 100 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white 11.0 mm round, flat tablets with break line on one
side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amisulpride Mylan is indicated for the treatment of acute and chronic
schizophrenic disorders:
Positive symptoms with delusions, hallucinations, thought disorders,
hostility and suspicious behavior.
Primarily negative symptoms (deficit syndrome) with blunted affect,
emotional and social withdrawal.
Amisulpride Mylan also controls secondary negative symptoms in
productive conditions as well as affective disorders
such as depressive mood or retardation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
For acute psychotic episodes the recommended oral dose ranges from 400
to 800 mg/day. In individual cases, the daily
dose may be increased up to 1200 mg/day. 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
Mylan. Doses should be adjusted according to individual response.
Maintenance treatment should be established
individually with the minimally effective dose.
For patients with mixed positive and negative symptoms, doses should
be adjusted to obtain optimal control of positive
symptoms.
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 Mylan can be administered once daily orally at a dose up
to 400 mg. Higher doses should be divided in
two doses.
_Elderly_
The safety of amisulpride has been examined in a limited number of
elderly patients. Amisulpride Myla