PHARMACOR AMISULPRIDE amisulpride 100 mg uncoated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amisulpride

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Amisulpride

Authorization status:

Registered

Patient Information leaflet

AMISULPRIDE/MAY 2017/CMI-00
1
Pharmacor Amisulpride
_contains the active ingredient amisulpride _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about PHARMACOR
AMISULPRIDE.
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 PHARMACOR
AMISULPRIDE 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 PHARMACOR
AMISULPRIDE is used for
PHARMACOR AMISULPRIDE 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.
PHARMACOR AMISULPRIDE belongs
to a group of medicines called
antipsychotics.
Your doctor may have prescribed
PHARMACOR AMISULPRIDE for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PHARMACOR
AMISULPRIDE HAS BEEN PRESCRIBED
FOR YOU.
PHARMACOR AMISULPRIDE must not
be taken by children up to the age
of puberty. There is limited
information on the use of
PHARMACOR AMISULPRIDE 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
PHARMACOR AMISULPRIDE is right
for you.
PHARMACOR AMISULPRIDE is
available only with a doctor's
prescription.
Before you take
PHARMACOR AMISULPRIDE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PHARMACOR
AMISULPRIDE 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 hi

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
PHARMACOR AMISULPRIDE (AMISULPRIDE), TABLETS
_ _
1. NAME OF THE MEDICINE
Amisulpride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pharmacor Amisulpride uncoated tablets contain the active amisulpride.
Pharmacor Amisulpride uncoated tablets are available in three
strengths and contain either 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
Pharmacor Amisulpride 100 mg uncoated tablets are white round flat
tablet, embossed with MC on one side.
Pharmacor Amisulpride 200 mg uncoated tablets are white round flat
tablet scored on one side.
Pharmacor Amisulpride 400 mg uncoated tablets are white biconvex,
capsule shaped tablet scored on both
sides.
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 esta