APO-Amisulpride 100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amisulpride, Quantity: 100 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Amisulpride

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

100, 30, 50, 60, 90

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 8.0 mm round flat tablets, with break line on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2011-11-03

Patient Information leaflet

APO-AMISULPRIDE
1
APO-AMISULPRIDE
_Amisulpride _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about amisulpride. It does
not contain all 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 using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Amisulpride belongs to a group of
medicines called antipsychotics.
It 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
amisulpride
•
any of the ingredients listed at the
end of this leaflet.
Some symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
ARE TAKING ANY OF THE FOLLOWING
MEDICINES:
•
medicines used to treat irregular
heart rhythm such as quinidine,
disopyramide, amiodarone and
sotalol
•
bepridil, used to treat angina
•
intravenous vincamine, used

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-AMISULPRIDE
(AMISULPRIDE) TABLET
1
NAME OF THE MEDICINE
Amisulpride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg, 100 mg, 200 mg or 400 mg amisulpride as
the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Amisulpride tablets contain sugars as lactose.
Amisulpride tablets are gluten free.
For the full list of excipients see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
50 MG TABLETS:
White to off-white 6.0 mm, round, biconvex tablets with breakline on
one side.
100 MG TABLETS:
White to off-white 8.0 mm, round, flat tablets with breakline on one
side.
200 MG TABLETS:
White to off-white 11.0 mm, round, flat tablets with breakline on one
side.
400 MG TABLETS:
White to off-white, 18 x 8 mm capsule shaped film-coated tablets with
breakline on one side.
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
Amisulpride tablets are intended for oral 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
2
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 twice daily for doses above 400 mg.
For patients with mixed positive and negative symptoms, doses should
be adjusted t