AMISULPRIDE SANDOZ PHARMA amisulpride 100 mg uncoated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amisulpride, Quantity: 100 mg

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Amisulpride

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

60, 90, 30

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, round, flat tablets with diameter 9.5 mm, embossed MC on one side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-01-29

Patient Information leaflet

Amisulpride Sandoz Pharma
1
AMISULPRIDE SANDOZ PHARMA
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKE AMISUPRIDE SANDOZ PHARMA?
Amisulpride Sandoz Pharma contains the active ingredient amisulpride.
Amisulpride Sandoz Pharma is used to the symptoms
of schizophrenia, a condition which affects the way you think, feel or
act.
For more information, see Section 1. Why am I take Amisulpride Sandoz
Pharma? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE AMISULPRIDE SANDOZ PHARMA?
Do not take if you have ever had an allergic reaction to amisulpride
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
Amisulpride Sandoz Pharma? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Amisulpride Sandoz Pharma and affect
how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE AMISULPRIDE SANDOZ PHARMA?
•
Tablets should be taken once or twice a day as advised by your doctor.
Your doctor will tell you how many tablets to take.
•
Swallow the tablets whole with a full glass of water.
•
Your doctor may increase or decrease your dose depending on your
condition.
More instructions can be found in Section 4. How do I take Amisulpride
Sandoz Pharma? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING AMISULPRIDE SANDOZ PHARMA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Amisulpride Sandoz Pharma.
•
Tell your doctor if you are starting any other new medicine.
•
Tell your doctor if your mood changes, including feelings of
depression or thoughts of self-harm.
THINGS YOU
SHOULD NOT DO
•
Do not stop takin

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
AMISULPRIDE SANDOZ PHARMA, (AMISULPRIDE) TABLETS
1. NAME OF THE MEDICINE
Amisulpride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Amisulpride Sandoz Pharma uncoated tablets contain the active
amisulpride.
Amisulpride Sandoz Pharma 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
Amisulpride Sandoz Pharma 100 mg uncoated tablets are white round flat
tablet, embossed with MC on one
side.
Amisulpride Sandoz Pharma 200 mg uncoated tablets are white round flat
tablet scored on one side.
Amisulpride Sandoz Pharma 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 tre