AMISULPRIDE SANDOZ 100 amisulpride 100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amisulpride

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Amisulpride

Authorization status:

Registered

Patient Information leaflet

Amisulpride Sandoz CMI
Page 1
Amisulpride Sandoz
®
_AMISULPRIDE _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
answers to some common
questions about this medicine. It
does not contain all the available
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
Amisulpride Sandoz against the
benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT AMISULPRIDE
SANDOZ IS USED FOR
The name of your medicine is
Amisulpride Sandoz. It contains
the active ingredient called
amisulpride.
Amisulpride Sandoz belongs to a
group of medicines called
antipsychotics. Amisulpride
Sandoz 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.
Your doctor may have prescribed
Amisulpride Sandoz for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
AMISULPRIDE SANDOZ HAS BEEN
PRESCRIBED FOR YOU.
BEFORE TAKING IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AMISULPRIDE SANDOZ
IF:
•
YOU HAVE AN ALLERGIC
REACTION TO AMISULPRIDE
SANDOZ OR ANY OF THE
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Signs of an allergic reaction
may include a skin rash,
itching, shortness of breath or
swelling of the face, lips or
tongue.
•
YOU ARE BREASTFEEDING OR PLAN
TO BREASTFEED
•
YOU ARE TAKING THE FOLLOWING
MEDICINES
-
medicines used to treat
irregular heart rhythm such as
quinidine, disopyramide,
amiodarone and sotalol
-
cisapride
-
antibiotics such as
erythromycin and pentamidine,
given as an injection into the
veins
-
levodopa, a medicine used in
Parkinson’s disease
-
th

Summary of Product characteristics

amisulpride-sandoz-ccdsv14-piv17-27oct20
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION – AMISULPRIDE SANDOZ
(AMISULPRIDE) TABLETS
1
NAME OF THE MEDICINE
Amisulpride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMISULPRIDE SANDOZ Tablets contain amisulpride (100 mg, 200 mg and 400
mg).
Excipient with known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
AMISULPRIDE SANDOZ 100mg: white to off white, flat-faced breakable
tablet, engraved
“AMI 100”.
AMISULPRIDE SANDOZ 200mg: white to off white, flat-faced breakable
tablet, engraved
“AMI 200”.
AMISULPRIDE SANDOZ 400mg: white, film-coated, breakable, oblong
tablet, engraved
“AMI 400”.
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.
amisulpride-sandoz-ccdsv14-piv17-27oct20
Page 2 of 19
Doses should preferably be administered before meals.
Amisulpride should be administered twice daily 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
minimall