AMISULPRIDE 200 WINTHROP amisulpride 200 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amisulpride, Quantity: 200 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Amisulpride

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; sodium starch glycollate type A; microcrystalline cellulose; magnesium stearate; hypromellose

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: white to off-white, round, flat-faced, scored tablet marked "AMI 200"; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-12-08

Patient Information leaflet

AMISULPRIDE WINTHROP
®
_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
Winthrop 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
WINTHROP IS USED FOR
The name of your medicine is
Amisulpride Winthrop. It contains
the active ingredient called
amisulpride.
Amisulpride Winthrop belongs to a
group of medicines called
antipsychotics. Amisulpride
Winthrop 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
(e.g. 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 Winthrop for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY AMISULPRIDE
WINTHROP HAS BEEN PRESCRIBED FOR
YOU.
BEFORE TAKING IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE AMISULPRIDE WINTHROP
IF:
•
YOU HAVE AN ALLERGIC
REACTION TO AMISULPRIDE
WINTHROP 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
-
thioridazone,

Summary of Product characteristics

amisulpride-winthrop-ccdsv15-piv18-25feb22
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION – AMISULPRIDE
WINTHROP (AMISULPRIDE) TABLETS
1
NAME OF THE MEDICINE
Amisulpride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMISULPRIDE WINTHROP tablets contain amisulpride (100 mg, 200 mg and
400 mg).
Excipient with known effect: sugars as lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
AMISULPRIDE WINTHROP 100: white to off white, flat-faced breakable
tablet, engraved
“AMI 100”.
AMISULPRIDE WINTHROP 200: white to off white, flat-faced breakable
tablet, engraved
“AMI 200”.
AMISULPRIDE WINTHROP 400: 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-winthrop-ccdsv15-piv18-25feb22
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
mi