Consumer medicine information

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 to increase blood flow to the brain
• cisapride, used to treat stomach problems
• halofantrine, used to treat malaria
• antibiotics such as intravenous erythromycin, pentamidine and sparfloxacin
• levodopa, used in Parkinson's disease
• antipsychotics such as thioridazine and sultopride
• methadone, used to treat pain or addiction

Do not take this medicine 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

Do not breastfeed if you are taking this medicine. Amisulpride passes into human breast milk, and therefore should not be taken when breastfeeding.

Do not give this medicine to a child under the age of 18 years. Safety and effectiveness in children younger than 18 years have not been established.

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) or diabetes – 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
• a history or are at risk of developing sleep apnoea

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.

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, also known as water or fluid tablets
• 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 label, 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.

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

It is very important to continue taking amisulpride because it will help you stay well.

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.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

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. 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.

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.

Some people experience increased sensitivity to the sun or notice symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal.

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.

Tell your doctor as soon as possible if you notice any of the following:

• sleepwalking or other related behaviours including sleep-related eating disorder

If you experience any of the following, contact your doctor immediately or go to Accident and Emergency at your nearest hospital:

• muscle symptoms including pain, weakness, twitching or stiffness
• abnormal movements, mainly of the face or tongue
• fever, unexplained infections
• faster breathing
• sweating
• 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
• yellowing of the skin and eyes, also called jaundice
• light coloured bowel motions
• dark coloured urine
• symptoms of an allergic reaction including cough, 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

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.

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 contains sugars as lactose.

This medicine is free from gluten, sucrose, tartrazine and other azo dyes.

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121
https://arrotex.com.au/

This leaflet was prepared in August 2023.

Published by MIMS September 2023

1 Name of 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.

3 Pharmaceutical Form

50 mg tablets.

100 mg tablets.

200 mg tablets.

400 mg tablets.

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 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 to obtain optimal control of positive symptoms.
Maintenance treatment should be established individually with the minimally effective dose.
For patients characterised by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually.

Elderly.

Children.

Renal impairment.

Hepatic impairment.

4.3 Contraindications

Hypersensitivity to the active ingredient or to other ingredients of the product.
Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer.
Phaeochromocytoma.
Children up to puberty.
Lactation.
In combination with the following medication which could induce torsades de pointes:
class Ia antiarrhythmic agents such as quinidine and disopyramide;
class III antiarrhythmic agents such as amiodarone and sotalol;
other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine, sparfloxacin.
Levodopa; reciprocal antagonism between levodopa and neuroleptics (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
In hepatic impairment, amisulpride may be contraindicated to avoid the possible risk of adverse events due to an influence of the disease on amisulpride metabolism.

4.4 Special Warnings and Precautions for Use

Neuroleptic malignant syndrome (NMS) is a potentially fatal syndrome that has been reported in association with anti-psychotic medicines, including amisulpride. Neuroleptic malignant syndrome is characterised by hyperthermia, muscle rigidity, rhabdomyolysis, autonomic instability, and elevated CPK, may occur. In the event of any symptoms which could suggest NMS, in particular hyperthermia, particularly with high daily doses, all antipsychotic medicines including amisulpride should be discontinued.
Rhabdomyolysis has also been observed in patients without NMS.
Amisulpride can lower the seizure threshold. Therefore patients with a history of seizures should be closely monitored during amisulpride therapy.
Withdrawal symptoms have been described after abrupt cessation of high therapeutic doses of antipsychotic drugs. The emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported with amisulpride. Therefore, gradual withdrawal of amisulpride is advisable.
Leucopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including amisulpride. Unexplained infections or fever may be evidence of blood dyscrasia and requires immediate haematological investigation.
Caution should be also exercised when prescribing amisulpride to patients with Parkinson's disease since it may cause worsening of the disease. Amisulpride should be used only if neuroleptic treatment cannot be avoided.
Amisulpride causes an increase in plasma prolactin levels which is reversible after discontinuation of the medicine. This may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain, orgasmic dysfunction and impotence.
Acute dystonia (spasm torticollis, oculogyric crisis, trismus) may appear. This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent.
Extrapyramidal symptoms may occur: tremor, rigidity, hypokinesia, hypersalivation, akathisia. These symptoms are generally mild at optimal dosages and partially reversible without discontinuation of amisulpride upon administration of antiparkinsonian medication. The incidence of extrapyramidal symptoms which is dose related, remains very low in the treatment of patients with predominantly negative symptoms with doses of 50-300 mg/day.
The presentation of akathisia may be variable and comprises subjective complaints of restlessness and an overwhelming urge to move and either distress or motor phenomena such as pacing, swinging of the legs while seated, rocking from foot to foot, or both. Particular attention should be paid to the monitoring for such symptoms and signs as, left untreated, akathisia is associated with poor compliance and an increased risk of relapse.
Tardive dyskinesia characterised by rhythmic, involuntary movements primarily of the tongue and/or face have been reported, usually after long-term administration. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms.

Hyperglycaemia and diabetes mellitus.

Prolongation of QT interval.

Stroke.

Venous thromboembolism.

Sleep apnoea.

Suicide.

Breast cancer.

Benign pituitary tumour.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Elderly patients with dementia.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

A number of medicines can increase the risk of ventricular arrhythmias including torsades de pointes.

Contraindicated combinations.

Combinations not recommended.

Combinations to be taken into account.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Even used as recommended, amisulpride may affect reaction time and/or cause somnolence and blurred vision so that the ability to drive vehicles or operate machinery can be impaired.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial data.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Class.

Clinical trials.

Acute exacerbations of schizophrenia.

Predominant negative schizophrenia.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

Hepatic insufficiency.

Renal insufficiency.

5.3 Preclinical Safety Data

An overall review of the completed safety studies indicates that amisulpride is devoid of any general, organ-specific, teratogenic, mutagenic or carcinogenic risk. Changes observed in rats and dogs at doses below the maximum tolerated dose are either pharmacological effects or are devoid of major toxicological significance under these conditions. Compared with the maximum recommended dosages in man, maximum tolerated doses are 2 and 7 times greater in the rat (200 mg/kg/d) and dog (120 mg/kg/d) respectively in terms of AUC. No carcinogenic risk, relevant to man, was identified in the mouse (up to 120 mg/kg/d) and in the rat (up to 240 mg/kg/d), corresponding for the rat to 1.5 to 4.5 times the expected human AUC.
Reproductive studies performed in the rat, rabbit and mouse did not show any teratogenic potential.

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, methylcellulose, sodium starch glycollate type A, microcrystalline cellulose, magnesium stearate, basic butylated methacrylate copolymer (400 mg tablets only), titanium dioxide (400 mg tablets only), purified talc (400 mg tablets only), macrogol 6000 (400 mg tablets only).

6.2 Incompatibilities

No data available.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

50 mg tablets.

100 mg tablets.

200 mg tablets.

400 mg tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Amisulpride is a white or almost white crystalline powder which is practically insoluble in water, freely soluble in methylene chloride, and sparingly soluble in anhydrous ethanol.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes