AMISOLAN 200 amisulpride 200 mg uncoated tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

amisulpride

Commercializzato da:

Southern Cross Pharma Pty Ltd

INN (Nome Internazionale):

Amisulpride

Stato dell'autorizzazione:

Registered

Foglio illustrativo

AMISULPRIDE/OCTOBER 2018/CMI-01
1
AMISOLAN
_contains the active ingredient amisulpride _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about AMISOLAN.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking AMISOLAN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your
medicine. You may need to read it
again.
What AMISOLAN is used for
AMISOLAN is used to treat
symptoms of schizophrenia.
Schizophrenia is a condition which
affects the way you think, feel
and/or act. Schizophrenia may
cause symptoms such as
hallucinations (eg hearing, seeing
or sensing things which are not
there), delusions, unusual
suspiciousness, emotional and
social withdrawal. People with
schizophrenia may also feel
depressed, anxious or tense.
AMISOLAN belongs to a group of
medicines called antipsychotics.
Your doctor may have prescribed
AMISOLAN for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY AMISOLAN
HAS BEEN PRESCRIBED FOR YOU.
AMISOLAN must not be taken by
children up to the age of puberty.
There is limited information on the
use of AMISOLAN in adolescents
and its use is not recommended
from puberty to the age of 18
years. If you are not yet 18 years of
age, ask your doctor if AMISOLAN is
right for you.
AMISOLAN is available only with a
doctor's prescription.
Before you take AMISOLAN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AMISOLAN IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
AMISULPRIDE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include skin
rash, itching or hives, swelling of
the face, lips or tongue which may
cause difficulty in swallowing or
breathing, wheezing or shortness of
breath.
DO NOT TAKE AMISOLAN IF YOU ARE
TAKING THE FOLLO

Scheda tecnica

AUSTRALIAN PRODUCT INFORMATION
AMISOLAN, (AMISULPRIDE) TABLETS
1. NAME OF THE MEDICINE
Amisulpride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
AMISOLAN tablets come in four strengths and contain either 50 mg, 100
mg, 200 mg or 400 mg of
amisulpride. Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
AMISOLAN 50 MG TABLETS:
White round flat tablet with diameter 7 mm
AMISOLAN 100 MG TABLETs:
White round flat tablet with diameter 9.5 mm, embossed with MC on one
side
AMISOLAN 200 MG TABLETS:
White round flat tablet scored on one side with diameter 11.5 mm
AMISOLAN 400 MG TABLETS:
White biconvex, capsule shaped tablet scored on both sides with
dimensions
19 x 10 mm
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. DOSE 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. Doses above 800
mg/d have not been shown to be
superior to lower doses and may increase the incidence of adverse
events. No specific titration is required
when initiating the treatment with amisulpride. Doses should be
adjusted according to individual response.
Doses should preferably be administered before meals.
Amisulpride should be administered bid for doses above 400 mg.
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