APO-Amisulpride 400 mg tablet blister pack

Main information

  • Trade name:
  • APO-Amisulpride 400 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-Amisulpride 400 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 178898
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

178898

APO-AMISULPRIDE 400 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

3/11/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. APO-Amisulpride 400 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

11/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. APO-Amisulpride 400 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, 18 x 8mm capsule shaped, film-coated tablets with

breakline on one side.

Active Ingredients

Amisulpride

400 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 10:02:21 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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, a medicine used to treat

angina

intravenous vincamine, a

medicine used to increase blood

flow to the brain

cisapride, a medicine used to treat

stomach problems

halofantrine, a medicine used to

treat malaria

antibiotics such as intravenous

erythromycin, pentamidine and

sparfloxacin

levodopa, a medicine used in

Parkinson's disease

antipsychotics such as

thioridazine and sultopride

methadone, a medicine used to

treat pain or addiction.

Tell your doctor if you have or

have had any of the following

medical conditions:

breast cancer

liver disease

tumour of the pituitary gland, a

small gland at the base of the

brain

phaeochromocytoma, a rare

tumour of the adrenal glands

which sits near the kidneys

Tell your doctor if you are breast-

feeding or plan to breastfeed.

Amisulpride passes into human

breast milk, and therefore should not

be taken when breastfeeding.

This medicine must not be taken

by children up to the age of

puberty. There is not enough

information on the use of

amisulpride in adolescents,

therefore the use of amisulpride

APO-AMISULPRIDE

from puberty to the age of 18 years

is not recommended.

Do not take this medicine if the

expiry date printed on the pack has

passed, the packaging is torn or

shows signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

kidney disease

liver disease

Parkinson's disease

fits or seizures

problems with the heart or blood

vessels

risk factors for stroke

history of blood clots

suffer from dementia

a history or family history of

breast cancer

a family history of,

hyperglycaemia (high sugar

levels in the blood). Your doctor

may recommend monitoring your

blood sugar levels while you are

taking amisulpride tablets.

mental/mood changes or suicidal

thoughts. Patients (and caregivers

of patients) need to monitor for

any worsening of their condition

and/or the development of

thoughts of suicide, suicidal

behaviour or thoughts of harming

themselves. Seek medical advice

immediately if these symptoms

present.

Tell your doctor if you are

pregnant, think you may be

pregnant or intend to become

pregnant.

Do not take this medicine whilst

pregnant until you and your doctor

have discussed the risks and benefits

involved. Like most antipsychotic

medicines, amisulpride is not

recommended for use during

pregnancy. There have been some

reports of side effects such as

shaking, muscle stiffness, breathing

difficulty and problems feeding in

newborn babies whose mothers have

taken this type of medicine during

the third trimester of pregnancy.

Tell your doctor if you suffer from

lactose intolerance.

APO-Amisulpride tablets contain

lactose.

Tell your doctor if you are

planning to have surgery, or you

are currently receiving or are

planning to receive dental

treatment.

If you have not told your doctor

about any of the above, tell them

before you start taking this

medicine.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and amisulpride

may interfere with each other. These

include:

medicines used to treat irregular

heart rhythm such as quinidine,

disopyramide, amiodarone and

sotalol

other medicines used to treat

heart problems such as diltiazem,

verapamil, clonidine, digoxin and

drugs known as beta blockers

(e.g. propranolol)

intravenous amphotericin B, an

anti-fungal given by injection into

the veins

other antipsychotics such as

thioridazine, clozapine,

chlorpromazine, trifluperazine,

pimozide, haloperidol,

imipramine and lithium

diuretics

stimulant laxatives

glucocorticosteroids

diagnostics drugs such as

tetracosactides

medicines taken for anxiety or to

help you sleep

anaesthetics (medicines used

during surgery)

medicines taken for depression

some strong pain killers

antihistamines, medicines to treat

allergies, which cause drowsiness

some medicines taken to control

blood pressure

These medicines may be affected by

this medicine or may affect how well

it works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

Other medicines not listed above

may also interact with amisulpride.

How to take this

medicine

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ to the information

contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

and whether you are taking any other

medicines.

How to take it

Swallow the tablets whole with a

full glass of water.

APO-AMISULPRIDE

When to take it

Take your medicine at about the

same time each day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

Amisulpride should be taken

preferably before meals.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

This medicine helps to control your

condition but does not cure it. It is

important to keep taking your

medicine even if you feel well.

Do not stop taking your medicine

or change your dosage without

first checking with your doctor.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is almost time to take your

next dose, skip the dose you missed

and take your next dose when you

are meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking your medicine as you would

normally.

Do not take a double dose to make

up for missed doses.

This may increase the chance of

experiencing side effects.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints to help

you remember.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice or

go to Accident and Emergency at

your nearest hospital, if you think

that you or anyone else may have

taken too much of this medicine.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

this medicine

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking this medicine.

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

Make sure you use contraception

to prevent pregnancy during

treatment. If you become pregnant

whilst taking this medicine, tell

your doctor immediately.

Tell your doctor immediately, or

go to the nearest hospital, if you

have suicidal thoughts, mental/

mood changes or aggressive

behaviour, including:

thoughts or talk of death or

suicide

thoughts or talk of self-harm or

harm to others

any recent attempts of self-harm

increase in aggressive behaviour,

irritability or agitation

depressed mood or worsening of

depression

Occasionally, the symptoms of

depression may include thoughts of

suicide or self-harm. These

symptoms may continue to get worse

during the early stages of treatment

until the effect of the medicine

becomes apparent. All mentions of

suicide or violence must be taken

seriously.

If you are about to have any blood

tests, tell your doctor that you are

taking this medicine.

It may interfere with the results of

some tests.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

It may affect other medicines used

during surgery.

Keep all of your doctor's

appointments so that your progress

can be checked.

Your doctor may do some tests from

time to time to make sure the

medicine is working and to prevent

unwanted side effects.

Things you must not do

Do not take this medicine to treat

any other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Things to be careful of

Be careful when driving or

operating machinery until you

know how this medicine affects

you.

This medicine may cause dizziness

or drowsiness in some people in

some people. If you have any of

these symptoms, do not drive,

operate machinery or do anything

else that could be dangerous.

Be careful if you are elderly or

unwell.

Some people may experience side

effects such as drowsiness,

confusion, dizziness and

unsteadiness, which may increase the

risk of a fall.

Be careful when drinking alcohol

while you are taking this medicine.

The effects of alcohol could be made

worse while taking this medicine. It

is not recommended that you drink

alcohol while taking this medicine.

Be careful while taking

antihistamines, sleeping tablets or

tablets to relieve pain while taking

this medicine.

Amisulpride can increase

drowsiness caused by medicines

affecting your nervous system.

APO-AMISULPRIDE

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

amisulpride.

This medicine helps most people

with schizophrenia, but it may have

unwanted side effects in a few

people. All medicines can have side

effects. Sometimes they are serious,

most of the time they are not. You

may need medical attention if you get

some of the side effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

drowsiness, dizziness

weight gain, increased appetite

nausea, vomiting

constipation

dry mouth

blurred vision

insomnia

anxiety, agitation

problems with orgasm

increases in blood pressure

photosensitivity reactions

urinary retention

respiratory infections

The above list includes the more

common side effects of your

medicine.

Some people may feel dizzy in the

early stages of treatment, especially

when getting up from a lying or

sitting position. This side effect

usually passes after taking this

medicine for a few days.

Sometimes trembling, noticeable

muscle stiffness or spasm, slowness

of movement, excess saliva,

restlessness, an overwhelming urge

to move and either distress or

movements such as pacing, swinging

of the legs while seated, rocking

from foot to foot, or both can occur.

This will usually be reduced if your

dose of this medicine is lowered by

your doctor or if your doctor

prescribes you an additional

medicine.

High blood sugar has been reported

in patients taking amisulpride.

Symptoms of high sugar levels in the

blood include passing more urine

than normal, persistent excessive

thirst, increased appetite with a loss

in weight and weakness.

After prolonged use in women,

medicine of this type can cause:

breast pain

milk secretion

an absence of their monthly

period

change in the regularity of their

periods

Tell your doctor if your monthly

periods are absent for six months or

more.

After prolonged use in men,

medicines of this type can cause

breast enlargement or impotence.

Incidences of abnormal liver function

have been occasionally reported.

If you experience any of the

following, contact your doctor

immediately or go to Accident and

Emergency at your nearest

hospital:

allergic reaction, including

symptoms such as shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, or other parts of the

body; rash, itching or hives on the

skin

muscle twitching

abnormal movements, mainly of

the face or tongue

fever, unexplained infections

faster breathing

sweating

muscle stiffness

symptoms of low white blood cell

count (leukopenia, neutropenia

and agranulocytosis) including

sudden fever, sore throat and

sores in mouth and gums,

sweating and chills

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may occur in some patients.

Some of these side effects, such as

leukopenia, can only be found when

your doctor does tests from time to

time to check your progress.

Storage and

Presentation

Storage

Keep your tablets in the pack until

it is time to take them.

If you take the tablets out of the

pack, they may not keep well.

Keep your medicine in a cool dry

place where the temperature will

stay below 25°C.

Do not store your medicine or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

APO-AMISULPRIDE

Product description

What APO-Amisulpride

looks like

Amisulpride 50 mg tablets - white to

off-white 6.0mm, round, bi-convex

tablets with breakline on one side.

AUST R 178900.

Amisulpride 100 mg tablets - white

to off-white 8.0mm, round, flat

tablets with breakline on one side.

AUST R 178904.

Amisulpride 200 mg tablets - white

to off-white 11.0mm, round, flat

tablets with breakline on one side.

AUST R 178902.

Amisulpride 400 mg tablets - white

to off-white, 18 x 8mm capsule

shaped, film-coated tablets with

breakline on one side. AUST R

178898.

Available in blister packs of 30, 50,

60, 90 or 100 tablets

*Not all strengths and/or pack sizes

may be available.

Ingredients

Each tablet contains 50, 100, 200 or

400 mg of amisulpride as the active

ingredient.

It also contains the following:

lactose monohydrate

methylcellulose

sodium starch glycollate (type A)

microcrystalline cellulose

magnesium stearate

The 400 mg tablets also contain:

basic butylated methacrylate

copolymer

titanium dioxide

purified talc

macrogol 6000.

This medicine is free from gluten,

sucrose, tartrazine and other azo

dyes.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

Apotex Pty Ltd is the licensee of the

registered trademarks APO and

APOTEX from the registered

proprietor, Apotex Inc.

This leaflet was prepared in May

2019.

APO-AMISULPRIDE