AMISULPRIDE MYLAN 400 Milligram Film Coated Tablet

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

AMISULPRIDE

Dostępny od:

McDermott Laboratories Ltd t/a Gerard Laboratories

INN (International Nazwa):

AMISULPRIDE

Dawkowanie:

400 Milligram

Forma farmaceutyczna:

Film Coated Tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Status autoryzacji:

Authorised

Data autoryzacji:

0000-00-00

Ulotka dla pacjenta

 
1 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

Amisulpride Mylan 400mg 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 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causes symptoms such as becoming withdrawn, sensing,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 ofthis 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 

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amisulpride Mylan 400 mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amisulpride Mylan contains 400 mg amisulpride per tablet.
Excipient with known effect:
200 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, 18 x 8 mm capsule shaped, film coated tablet 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 characterized by predominant negative symptoms, oral doses between 50 mg/day and 300 mg/day are
recommended.�