Sulprix

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Amisulpride 50 mg
Available from:
Viatris Limited
INN (International Name):
Amisulpride 50 mg
Dosage:
50 mg
Pharmaceutical form:
Tablet
Composition:
Active: Amisulpride 50 mg Excipient: Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sodium starch glycolate
Prescription type:
Prescription
Manufactured by:
Laboratorios Espinos Y Bofill SA (LEBSA)
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:
Package - Contents - Shelf Life: Blister pack, PVC/Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 50 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 60 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 90 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 100 tablets - 24 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-9333
Authorization date:
2013-06-25

Read the complete document

Page 1 of 4

NEW ZEALAND CONSUMER MEDICINE INFORMATION

SULPRIX

Amisulpride Tablets 100 mg, 200 mg and 400 mg

What is in this leaflet

Please read this leaflet carefully

before you start taking Sulprix.

This leaflet answers some common

questions about Sulprix.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking SULPRIX

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 the

medicine. You may need to read it

again.

What Sulprix is used

for

Sulprix is used to treat symptoms of

schizophrenia, which is a condition

that affects the way you think, feel

and/or act. Schizophrenia may

cause symptoms such as

hallucinations, delusions, unusual

suspiciousness, emotional and

social withdrawal. People with

schizophrenia may also feel

depressed, anxious or tense.

Sulprix contains the active

ingredient amisulpride. It belongs to

a group of medicines called

antipsychotics.

Your doctor may have prescribed it

for another reason.

Ask your doctor if you have any

questions about why this

medicine has been prescribed for

you.

This medicine is available only with

a doctor’s prescription.

Before you take

Sulprix

When you must not take

it

Do not take Sulprix if you have an

allergy to:

any medicine containing

amisulpride

any of the ingredients listed at

the end of this leaflet.

Some of the symptoms of an

allergic reaction may include:

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.

Do not take Sulprix if you are

taking the following medicines:

medicines used to treat irregular

heart rhythm or heart conditions

such as quinidine, disopyramide,

amiodarone, sotalol and bepridil

antibiotics such as erythromycin

and pentamidine, given as an

injection into the veins or

sparfloxacin tablets taken by

mouth

halofantrine, a medicine used to

treat malaria

levodopa, a medicine used in

Parkinson’s disease

antipsychotic medicines such as

thioridazine and sultopride

methadone, a medicine used to

treat pain or addiction

cisapride, a medicine used to

treat heartburn

vincamine, an antihypertensive

agent.

Do not take this medicine if you

are pregnant.

It may affect your developing baby if

you take it during pregnancy.

Do not breast-feed if you are

taking this medicine.

The active ingredient in Sulprix

passes into breast milk and there is

a possibility that your baby may be

affected. Breast-feeding is

contraindicated in patients taking

Sulprix.

Do not give this medicine to

children or adolescents under the

age of 18 years.

Safety and effectiveness in children

and adolescents have not been

established. From puberty to the

age of 18 years Sulprix is not

recommended. In children up to

puberty, Sulprix should not be used.

Do not take Sulprix if you have or

have had any of the following

medical conditions:

phaeochromocytoma, a rare

tumour of the adrenal glands

which sit near the kidneys

tumour of the pituitary gland, a

small gland at the base of the

brain

breast cancer

liver disease.

Do not take this medicine after

the expiry date printed on the

pack or if 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 or liver disease

Parkinson’s disease

Page 2 of 4

history of seizures

problems with the heart and

blood vessels, low blood

pressure

history of blood clots

diabetes, history of high blood

sugar levels (hyperglycaemia)

or family history of diabetes

dementia

mood changes or suicidal

thoughts

risk factors for stroke

history or family history of

breast cancer

restlessness

unusual muscle tone

uncontrollable movements

tumour of pituitary gland

fever or high bod temperature

muscle rigidity.

Tell your doctor if you are

pregnant or plan to become

pregnant.

Your doctor can discuss with you

the risks and benefits involved.

If you have not told your doctor

about any of the above, tell them

before you start taking Sulprix.

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.

You should also tell any healthy

professional who is prescribing a

new medication for you that you are

taking Sulprix.

Some medicines may interfere with

Sulprix. These include:

medicines used to treat

irregular heart rhythm such as

quinidine, disopyramide,

amiodarone, sotalol, digitalis

and bepridil

medicines used to treat heart

problems such as diltiazem,

verapamil, clonidine, digoxin

and beta blockers

intravenous amphotericin B, an

anti-fungal given by injection

into the veins

other antipsychotics medicines

such as thioridazine,

chlorpromazine, trifluperazine,

pimozide, haloperidol,

imipramine, lithium and

clozapine

diuretics also known as fluid

tablets

stimulant laxatives

glucocorticosteroids such as

prednisone, dexamethasone

and hydrocortisone

diagnostics drugs such as

tetracosactides

medicines taken for anxiety,

depression or to help you sleep,

such as barbiturates and

benzodiazepine

some strong pain killers

some antihistamines, used to

treat allergies, which cause

drowsiness

some medicines taken to

control blood pressure

guanfacine, a medicine used to

treat attention deficit

hyperactivity disorder.

These medicines may be affected

by Sulprix 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.

How to take Sulprix

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from 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 many

tablets you should take. The dose

your doctor will prescribe for you will

usually be in the range of 400 mg to

800 mg per day.

Your doctor may increase or

decrease your dose depending on

your condition.

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 times each day.

Taking it at the same times each

day will have the best effect. It will

also help you remember when to

take it.

Sulprix tablets should be taken

once or twice a day preferably

before food.

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.

If you forget to take it

If it is almost time for 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 the dose that you

missed.

This may increase the chance of

you getting an unwanted side effect.

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.

While you are taking

Sulprix

Things you must do

If you are about to be started on

any new medicine, tell your

doctor and pharmacist that you

are taking Sulprix.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist

Page 3 of 4

that you are taking this medicine.

It may affect other medicines used

during surgery.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

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.

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.

Talk to your doctor or health

professional if you have any of

the following suicidal thoughts or

mood changes:

thoughts or talk about death or

suicide

thoughts or talk about self-harm

or doing harm to others

any recent attempts of self-

harm

increase in aggressive

behaviour, irritability or agitation

depressed mood or worsening

of depression.

Seek medical advice immediately if

these symptoms present. These

may be signs of changes or

worsening of your condition.

Things you must not do

Do not take Sulprix 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.

If you stop taking it suddenly, your

condition may worsen or you may

have unwanted side effects such as

restlessness, unusual muscle tone

and uncontrollable twitching, jerking

or writhing movements.

If possible, your doctor will gradually

reduce the amount you take each

day before stopping the medicine

completely.

Things to be careful of

Be careful driving or operating

machinery until you know how

Sulprix affects you.

This medicine may cause

drowsiness and blurred vision 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 when drinking alcohol

while you are taking this

medicine.

If you drink alcohol, symptoms such

as drowsiness and blurred vision

may be worse.

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially when

you get up from bed or chairs, will

help your body get used to the

change in position and blood

pressure. If this problem continues

or gets worse, talk to your doctor.

In case of overdose

Immediately telephone your

doctor or the National Poisons

Information Centre (0800 POISON

or 0800 764 766) for advice, or go

to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

taken too much Sulprix. Do this

even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

Symptoms of an overdose may

include drowsiness, dizziness,

lightheadedness, unusual

movements and reduced levels of

consciousness.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are taking

Sulprix.

This medicine helps most people,

but it may have unwanted side

effects in a few people.

If you are over 65 years of age you

may have an increased chance of

getting side effects such as

drowsiness, confusion, dizziness

and unsteadiness.

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.

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

headaches

constipation

nausea and vomiting

dry mouth

trouble sleeping

weight gain

nasal congestion

anxiety

agitation

problems with orgasm.

The above list includes the more

common side effects of your

medicine.

Tell your doctor as soon as

possible if you notice any of the

following:

falling, feeling faint or dizzy on

standing up

blurred vision

confusion

unusual movements, including

trembling and shaking or the

hands and fingers

restlessness or difficulty sitting

still

stiffness of the arms and legs

reduced or slow body

movement

difficulty passing urine

unusual secretion of breast milk

breast enlargement

absence of menstrual periods

and changes in the regularity of

menstrual periods

symptoms of high sugar levels

in the blood (including passing

large amounts of urine,

excessive thirst, having a dry

mouth and skin and weakness).

These may indicate the onset or

worsening of diabetes.

Page 4 of 4

Sleep walking or sleep related

eating disorder.

The above list includes serious side

effects that may require medical

attention.

If any of the following happen,

tell your doctor immediately or

go to Accident and Emergency at

your nearest hospital:

an allergic reaction (symptoms

may include: 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)

seizures, fits or convulsions

uncontrollable twitching or

jerking movements of the

tongue, mouth, cheeks, or jaw

which may progress to the arms

and legs

sudden increase in body

temperature, sweating, fast

heartbeat, muscle stiffness,

high blood pressure

changes to heart rate

sharp chest pain, coughing of

blood, or sudden shortness of

breath

weakness or numbness in any

part of your body

severe pain, swelling or

discolouration in either of your

legs

unexplained infections or fever

increased skin sensitivity to

light.

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 also occur in some people. Tell

your doctor if you notice any other

effects.

Some of these side effects (for

example, changes in blood cell

counts, cholesterol or triglyceride

level, changes to bone density) can

only be found when your doctor

does tests from time to time to

check your progress.

Do not be alarmed by this list of

possible side effects. You may

not experience any of them.

After taking Sulprix

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 tablets in a cool dry

place where the temperature

stays below 25°C.

Do not store Sulprix 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 it looks like

Sulprix 100 mg tablets are white

round shaped tablets with “AMI”

breakline “100” on one side and “G”

on the other.

Sulprix 200 mg tablets are white

round shaped tablets with “AMI”

breakline “200” on one side and “G”

on the other.

Sulprix 400 mg tablets are white

film-coated capsule shaped tablets

with “AS 400” on one side and a

breakline on the other.

Ingredients

Active ingredient(s):

Sulprix contains either 100, 200 or

400 mg of amisulpride as the active

ingredient.

Inactive ingredient(s):

Sulprix also contains:

hypromellose

lactose monohydrate

magnesium stearate

microcrystalline cellulose

sodium starch glycolate.

Additionally, the 400 mg tablets also

contain:

titanium dioxide

macrogol.

This medicine does not contain

gluten.

If you want to know

more

Should you have any questions

regarding this product, please

contact your pharmacist or doctor.

Who supplies this

medicine

Sulprix is supplied in New Zealand

Mylan New Zealand Ltd,

PO Box 11183,

Ellerslie,

Auckland

NEW ZEALAND

Telephone: (09) 579 2792

Date of Information

5 May 2020

(Based on datasheet dated 5 May

2020)

Read the complete document

Page 1 of 12

NEW ZEALAND DATA SHEET

SULPRIX

1. Product Name

SULPRIX, 50 mg, 100 mg & 200 mg, tablet.

SULPRIX, 400 mg, film coated tablet.

2. Qualitative and Quantitative Composition

Each tablet contains 50 mg, 100 mg, 200 mg or 400 mg of amisulpride.

SULPRIX tablets contain lactose.

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

SULPRIX Tablets 50 mg: White round shaped tablets with 'AA 50' on one side and 'G' on the reverse,

approximately 6 mm in diameter.

SULPRIX Tablets 100 mg: White round shaped tablets with 'AMI' breakline '100' on one side and 'G'

on the reverse, approximately 7.5 mm in diameter.

SULPRIX Tablets 200 mg: White round shaped tablets with 'AMI' breakline '200' on one side and 'G'

on the reverse, approximately 10 mm in diameter.

SULPRIX Film-coated Tablets 400 mg: White film-coated, 18 mm capsule shaped tablet, embossed

with "AS 400" on one side and a break-line on the reverse.

The 100 mg, 200 mg and 400 mg tablets can be divided into equal doses.

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

blunted

affect,

emotional

social

withdrawal)

prominent,

including

patients

characterised by predominant negative symptoms.

4.2

Dose and method of administration

For acute psychotic episodes, oral doses between 400 mg/day and 800 mg/day are recommended.

In individual cases, the daily dose may be increased up to 1200 mg/day. Doses above 1200 mg/day

have not been extensively evaluated for safety and therefore should not be used. Doses above

800 mg/day 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.

Page 2 of 12

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/day and

300 mg/day are recommended. Doses should be adjusted individually.

Special populations

Elderly

Amisulpride should be used with particular caution because of a possible risk of hypotension or

sedation.

Paediatric

Amisulpride is contra-indicated in children up to puberty as its safety has not yet been established.

Renal insufficiency

Amisulpride is eliminated by the renal route. In renal insufficiency, the dose should be reduced to

half in patients with creatinine clearance (CR

between 30-60 mL/min and to a third in patients with

between 10-30 mL/min. As there is no experience in patients with severe renal impairment

< 10 mL/min) particular care is recommended in these patients (see section 4.4)

Hepatic insufficiency

Since amisulpride is weakly metabolised, a dosage reduction should not be necessary (see section

4.4)

4.3

Contraindications

Hypersensitivity to the active ingredient or to any of the excipients listed in section 6.1.

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

bepridil,

cisapride,

sultopride,

thioridazine,

methadone,

intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine, sparfloxacin.

Levodopa; reciprocal antagonism between levodopa and neuroleptics (see section 4.5).

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 antipsychotic medicines, including amisulpride. Neuroleptic malignant syndrome is

Page 3 of 12

characterised by hyperthermia, muscle rigidity, 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.

Hyperglycaemia has been reported in patients treated with some atypical antipsychotic agents,

including amisulpride, therefore patients with an established diagnosis of diabetes mellitus or with

risk factors for diabetes who are started on amisulpride, should get appropriate glycaemic

monitoring.

Amisulpride is eliminated by the renal route. In cases of renal insufficiency, the dose should be

decreased and intermittent treatment should be considered (see section 4.2)

There are limited data on the potential for renally-cleared medicines to interfere with the clearance

of amisulpride. Therefore, amisulpride should be used with caution with other renally-excreted

medicines, including lithium (see section 4.5).

The impact of hepatic impairment on hepatic metabolism and hepato-biliary excretion of amisulpride

has not been studied. Amisulpride should be used with caution in patients with moderate or severe

hepatic impairment.

Amisulpride can lower the seizure threshold. Therefore patients with a history of seizures should be

closely monitored during amisulpride therapy.

In elderly patients, amisulpride therapy, like other neuroleptics, should be used with particular caution

because of a possible risk of hypotension or sedation.

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.

Leukopenia, 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 anti-parkinsonian 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 anti-parkinsonian 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.

Tardive dyskinesia characterised by rhythmic, involuntary movements primarily of the tongue and/or

face have been reported, usually after long-term administration. Anti-parkinsonian medication is

ineffective or may induce aggravation of the symptoms.

Page 4 of 12

Prolongation of QT interval

Amisulpride produces a dose-dependent prolongation of the QT interval (see section 4.8). This effect

is known to potentiate the risk of occurrence of serious ventricular arrhythmias such as torsades de

pointes. Before any administration, and if possible according to the patient's clinical status, it is

recommended to monitor factors which could favour the onset of this rhythm disorder, for example:

Bradycardia less than 55 bpm

Electrolyte imbalance, in particular hypokalaemia

Congenital prolongation of the QT interval

On-going treatment with a medication likely to produce pronounced bradycardia (< 55 bpm),

hypokalaemia, slowing of the intracardiac conduction, or prolongation of the QT

interval (see

section 4.5).

Stroke

In randomized clinical trials versus placebo performed in a population of elderly patients with

dementia and treated with certain atypical antipsychotic medicines, a 3-fold increase of the risk of

cerebrovascular events has been observed. The mechanism of such risk increase is not known. An

increase in the risk with other antipsychotic medicines, or other populations of patients cannot be

excluded. Amisulpride should be used with caution in patients with stroke risk factors.

Elderly patients with dementia

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased

risk of death. Although the causes of death in clinical trials with atypical antipsychotics were varied,

most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) or

infectious (e.g. pneumonia) in nature. Observational studies suggest that, similar to atypical

antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The

extent to which the findings of increased mortality in observational studies may be attributed to the

antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.

Venous thromboembolism

Cases of venous thromboembolism, sometimes fatal, have been reported with antipsychotic drugs.

Therefore, amisulpride should be used with caution in patients with risk factors for thromboembolism

(see section 4.8).

Sleep apnoea

No cases of sleep apnoea clearly attributed to amisulpride have been reported and no epidemiology

studies can substantiate this. However, sleep apnoea and related disorders have been reported in

patients treated with other antipsychotic medicines, with or without prior history of sleep apnoea, in

patients with or without concomitant weight-gain. Patients who have a history of or are at risk for

sleep apnoea, or who are concomitantly using central nervous system depressants, should be

medically monitored.

Suicide

The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder, and close

supervision of high-risk patients should accompany therapy.

Breast cancer

Amisulpride may increase prolactin levels. Therefore, caution should be exercised and patients with

a history or a family history of breast cancer should be closely monitored during amisulpride therapy.

Benign pituitary tumour

Amisulpride may increase prolactin levels. Cases of benign pituitary tumours, such as prolactinoma,

have been observed during amisulpride therapy. In case of very high levels of prolactin or clinical

signs of pituitary tumour (such as visual field defect and headache), pituitary imaging should be

Page 5 of 12

performed. If the diagnosis of pituitary tumour is confirmed, the treatment with amisulpride must be

stopped.

Paediatric use

The efficacy and safety of amisulpride from puberty to the age of 18 years have not been established:

there are limited data available on the use of amisulpride in adolescents with schizophrenia.

Therefore, the use of amisulpride from puberty to the age of 18 years is not recommended. In

children up to puberty, the use of amisulpride is contraindicated (see section 4.3).

4.5

Interaction with other medicines and other forms of interaction

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

The use of the following medicines is contraindicated:

Medications 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 of effects between levodopa and neuroleptics.

The use of the following medicines is not recommended:

Amisulpride may enhance the effects of alcohol.

Medications which enhance the risk of torsades de pointes or could prolong the QT interval.

Medicines which induce bradycardia, such as bradycardia-inducing calcium channel blockers

(diltiazem, verapamil), beta-blockers, clonidine, guanfacine, digitalis.

Medicines which can cause hypokalaemia, such as diuretics, stimulant laxatives, intravenous

amphotericin B, glucocorticoids, tetracosactides. Hypokalaemia should be corrected.

Neuroleptics such as thioridazine, chlorpromazine, trifluperazine, pimozide, haloperidol,

imipramine antidepressants, lithium.

The use of the following medicines should be taken into account:

Concomitant use of amisulpride with other antipsychotics may increase the risk of

developing neuroleptic malignant syndrome.

Co-administration of amisulpride and clozapine may lead to an increase in plasma levels of

amisulpride.

Amisulpride may enhance the effects of the following medicines:

CNS depressants including narcotics, anaesthetics, analgesics, sedative H

-antihistamines,

barbiturates, benzodiazepines and other anxiolytic medicines, clonidine and derivatives.

Antihypertensive medicines and other hypotensive medications.

A placebo-controlled study of concomitant use of lithium carbonate 500 mg twice daily and a low

dose of amisulpride (100 mg) twice daily in healthy young male volunteers showed no effect of

amisulpride on the pharmacokinetics of lithium. A small trend towards prolongation of the QT

interval

was observed when lithium and amisulpride were co-administered but is not regarded as clinically

important.

A study of the effect of concomitant use of cimetidine on amisulpride excretion has not been

conducted.

In vitro studies using human liver microsomes and cryopreserved human hepatocytes did not show

evidence of significant amisulpride metabolism. Based on these results, it is unlikely that drug

interactions involving amisulpride would occur due to inhibition or induction of cytochrome P450-

mediated metabolism.

Page 6 of 12

4.6

Fertility, pregnancy and lactation

Pregnancy (category B3)

There was no evidence of teratogenicity in embryofoetal development studies in mice and rabbits

following oral doses vehicle of up to 2 (mice) and 4 (rabbits) times the maximum recommended

human dose based on body surface area, administered daily during the period of organogenesis.

Oral treatment of female rats from prior to mating to late gestation or weaning, achieving systemic

drug exposure (plasma AUC) similar to that in humans at the maximum dose, was associated with

increased preimplantation loss, slight impairment of ossification and reduced pup weight gain to

weaning. Teratogenicity was not observed.

The safety of amisulpride during human pregnancy has not been established, and therefore use of

this medicine is not recommended during pregnancy unless the benefits justify the potential risks.

Neonates exposed to antipsychotics, including amisulpride, during the third trimester of pregnancy

are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary

in severity and duration following delivery. There have been reports of agitation, hypertonia,

hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns

should be monitored carefully.

Breast-feeding

It is not known whether amisulpride or its metabolites are excreted in animal or human breast milk.

Breast-feeding is therefore contraindicated during amisulpride treatment.

Fertility

No data available. For pre-clinical fertility data refer to section 5.3.

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

Undesirable effects

Adverse effects have been ranked under headings of frequency using the following convention: very

common

(≥1/10);

common

(≥1/100;

<1/10);

uncommon

(≥1/1,000;

<1/100);

rare

(≥1/10,000;

<1/1,000); very rare (<1/10,000), frequency not known (cannot be estimated from the available data).

The following adverse reactions have been observed in controlled clinical trials and through

spontaneous reporting.

Blood and lymphatic system disorders

Uncommon:

Leucopenia, neutropenia

Rare:

Agranulocytosis (see section 4.4)

Immune system disorders

Uncommon:

Allergic reactions

Endocrine disorders

Common:

Amisulpride causes an increase in plasma prolactin levels, which is reversible

after drug discontinuation. This may result in galactorrhoea, amenorrhoea,

gynaecomastia, breast pain, and erectile dysfunction.

Rare:

Benign pituitary tumour such as prolactinoma (see sections 4.3 and 4.4)

Metabolism and nutritional disorders

Uncommon:

Hyperglycaemia (see section 4.4), hypertriglyceridaemia and

hypercholesterolaemia

Page 7 of 12

Rare:

Hyponatraemia and syndrome of inappropriate antidiuretic hormone secretion

(SIADH)

Psychiatric disorders

Common:

Insomnia, anxiety, agitation, orgasmic dysfunction

Uncommon:

Confusion

Nervous system disorders

Very common:

Extrapyramidal

symptoms

occur:

tremor,

rigidity,

hypokinesia,

hypersalivation, akathisia, dyskinesia. These symptoms are generally mild at

optimal dosages and partially reversible without discontinuation of amisulpride

upon

administration

anti-parkinsonian

medication.

incidence

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.

Common:

Acute dystonia (spasm torticolis, oculogyric crisis, trismus) may appear. This

is reversible without discontinuation of amisulpride upon treatment with an

anti-parkinsonian agent. Somnolence.

Uncommon:

Tardive

dyskinesia

characterised

rhythmic,

involuntary

movements

primarily of the tongue and/or face has been reported, usually after long-term

administration. Anti-parkinsonian medication is ineffective or may induce

aggravation of the symptoms. Seizures.

Rare:

Neuroleptic Malignant Syndrome (see section 4.4), which is a potentially fatal

complication.

Somnambulism (sleepwalking) and related behaviours including sleep-related

eating disorder have been reported with the use of atypical antipsychotic

medicines, including amisulpride.

Eye disorders

Common:

Blurred vision (see section 4.7)

Cardiac disorders

Common:

QT interval prolongation

Uncommon:

Bradycardia

Rare:

Ventricular arrhythmias such as torsades de pointes, ventricular tachycardia,

which may result in ventricular fibrillation or cardiac arrest, sudden death, have

been reported (see section 4.4).

Vascular disorders

Common:

Hypotension

Uncommon:

Increase in blood pressure

Rare:

Venous thromboembolism, including pulmonary embolism, sometimes

fatal,

and deep vein thrombosis (see section 4.4).

Respiratory, thoracic and mediastinal disorders

Uncommon:

Nasal congestion, pneumonia aspiration (mainly in association with other

antipsychotics)

Gastrointestinal disorders

Common:

Constipation, nausea, vomiting, dry mouth

Hepatobiliary disorders

Uncommon: Hepatocellular injury

Skin and subcutaneous tissue disorders

Rare:

Angioedema and urticaria

Page 8 of 12

Musculoskeletal and connective tissue disorders

Uncommon:

Osteopenia and osteoporosis

Renal and urinary disorders

Uncommon:

Urinary retention

Pregnancy, puerperium and perinatal conditions

Neonatal drug withdrawal syndrome has been reported.

Investigations

Common:

Weight gain

Uncommon:

Elevations of hepatic enzymes, mainly transaminases

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked

to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

4.9

Overdose

Symptoms

Experience with amisulpride in overdosage is limited. Exaggeration of the known pharmacological

and adverse effects of amisulpride have been reported. These may include drowsiness, sedation,

hypotension, extrapyramidal symptoms and coma.

Fatal outcomes have been reported mainly in combination with other psychotropic agents.

Management

In cases of acute overdose, the possibility of multiple drug intake should be considered.

There is no specific antidote to amisulpride. Appropriate supportive measure should therefore be

instituted: close supervision of vital functions and, because of the risk of prolongation of QT interval,

continuous cardiac monitoring until the patient recovers.

If severe extrapyramidal symptoms occur, anticholinergic agents should be administered.

Since amisulpride is weakly dialysed, haemodialysis is not recommended as a method of elimination.

For further advice on management of overdose please contact the National Poisons Information

Centre (0800 POISON or 0800 764 766).

5. Pharmacological Properties

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Benzamide antipsychotic, ATC code: N05AL05.

Amisulpride is a neuroleptic of the benzamide class.

Amisulpride binds selectively to the human dopaminergic D

(Ki 2.8 nM) and D

(Ki 3.2 nM) receptor

subtypes without any affinity for D

and D

receptor subtypes (Ki > 1 µM).

Unlike classical and

atypical neuroleptics, amisulpride displays low affinity for serotonin, α-adrenergic, histamine receptor

subtypes, muscarinic receptors and sigma sites.

In the rodent, it preferentially blocks post-synaptic D

receptors located in the limbic structures as

compared

those

striatum

indicated

reversal

d-amphetamine-induced

Page 9 of 12

hyperactivity without affecting stereotypies. In addition, it does not induce catalepsy and it does not

produce D

hypersensitivity after repeated treatment.

Moreover, it preferentially blocks pre-synaptic D

dopamine receptors, producing dopamine

release responsible for its disinhibitory effects.

This atypical pharmacological profile may explain amisulpride's antipsychotic effect at higher doses

through post-synaptic dopamine receptor blockade located in the limbic areas and its efficacy against

negative symptoms, at lower doses, through presynaptic dopamine receptor blockade. In addition,

the reduced tendency of amisulpride to produce extrapyramidal side effects may be related to its

preferential limbic activity.

5.2

Pharmacokinetic properties

In man, amisulpride shows two absorption peaks: one which is attained rapidly, one hour post-dose

and a second between 3 and 4 hours after administration. Corresponding plasma concentrations are

39±3 and 54±4 ng/mL after a 50 mg dose.

The volume of distribution is 5.8 L/kg. As plasma protein binding is low (16%), drug interactions due

to displacement are unlikely.

The absolute bioavailability of amisulpride tablets is 48%.

SULPRIX

tablets

interchangeable

with

amisulpride

solution.Amisulpride

weakly

metabolised: two inactive metabolites, accounting for approximately 4% of the dose, have been

identified. The elimination half-life of amisulpride is approximately 12 hours after an oral dose.

Fifty percent of an intravenous dose is excreted via the urine, the majority as unchanged drug. Ninety

percent of the intravenous dose is eliminated in the first 24 hours. Renal clearance is in the order of

20 L/h or 330 mL/min.

Following a single intravenous dose, about 20% of the dose was recovered from the faeces, about

70% of which was as unchanged amisulpride. Hepatic metabolism has a limited role in healthy

patients.

A high-carbohydrate low-fat meal (14 g protein, 8 g fat, 108 g CHO) significantly decreases the AUC,

and C

of amisulpride, but no changes were seen after a high fat meal. However, the

significance of these findings in routine clinical use is not known.

Hepatic insufficiency: See section 4.4.

Renal insufficiency: In patients with renal insufficiency systemic clearance is reduced by a factor of

2.5 to 3. The AUC of amisulpride in mild renal failure increased two-fold and almost ten-fold in

moderate renal failure. Experience is, however, limited and there is no data with doses greater than

50 mg.

Amisulpride is very weakly dialysed.

Limited pharmacokinetic data in elderly subjects (> 65 years) show that a 10-30% rise occurs in C

and AUC after a single oral dose of 50 mg. No data are available after repeat dosing.

Clinical Trials

The efficacy of amisulpride in the treatment of schizophrenia has been established on the basis of

eleven phase II and III studies conducted in 20 countries and involving 1933 patients (1247 treated

with amisulpride) belonging to two distinct populations:

patients with acute exacerbations of schizophrenia

Page 10 of 12

patients with predominant negative schizophrenia.

These studies form the basis of the registration documentation for amisulpride. Seven of them are

considered pivotal for efficacy and their results are summarized below.

Acute exacerbations of schizophrenia

In four well-controlled double-blind studies versus reference medicines in patients with acute

schizophrenia according to DSM III-R and DSM-IV criteria, amisulpride was at least as effective as

haloperidol, flupenthixol and risperidone. In addition to its global antipsychotic activity, amisulpride

significantly alleviated secondary negative symptoms as well as affective symptoms such as

depressed mood and retardation.

A 4-week double-blind active-controlled trial (n=319) compared four fixed doses of amisulpride

(100 mg/day, 400 mg/day, 800 mg/day and 1200 mg/day) and a fixed dose of haloperidol

(16 mg/day). A dose response relationship was clearly established in comparison to 100 mg/day,

chosen as a potentially subtherapeutic dose in acute schizophrenia. Amisulpride at doses of 400

and 800 mg/day statistically significantly improved positive symptoms (BPRS total score, PANSS

positive symptoms subscale) compared with amisulpride 100 mg/day. 800 mg/day of amisulpride

was also statistically significantly superior to 100 mg/day for response rates based on the CGI.

Efficacy results were similar in the three other short-term controlled studies where 800 mg/day

of amisulpride was compared with 20 mg/day of haloperidol (n=191), 1000 mg/day of amisulpride

with 25 mg/day of flupenthixol (n=132) and 800 mg/day of amisulpride with 8 mg of risperidone

(n=228). On BPRS total score and PANSS positive subcale, amisulpride was not found to be

different from haloperidol and flupenthixol and showed equivalent efficacy to risperidone.

Additionally, amisulpride significantly improved the response rate with CGI versus haloperidol.

Predominant negative schizophrenia

Three pivotal trials were conducted versus placebo in schizophrenic patients with predominant

negative symptoms according to DSM III and DSM III-R, showing that low doses of amisulpride are

active against negative symptoms.

In a six-week dose finding study (n=104), amisulpride 100 mg/day and 300 mg/day were

significantly better than placebo on the basis of the SANS total score.

In an additional 3-month dose finding study (n=242) testing two fixed dose of amisulpride

(50 mg/day and 100 mg/day) versus placebo, both doses of amisulpride were significantly more

active in improving the negative symptoms than placebo on the SANS total score. Additionally,

there was a significant improvement of the MADRS scores in the two amisulpride groups.

A medium-/long-term placebo controlled study with amisulpride 100 mg/day over 6 months with

the possibility of extension up to 12 months was conducted to demonstrate the maintenance of

efficacy over time. Amisulpride improved negative symptoms (SANS total score) significantly

compared with placebo, and the response rate with CGI was significantly higher in the

amisulpride group versus placebo. The results were confirmed by the significant improvement of

global functioning measured with the GAF. SANS total score remained stable over time up to 12

months, indicating that 100 mg/day not only maintains the improvement of negative symptoms

but has also an effect on preventing the recurrence of positive symptoms.

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/day) and

dog (120 mg/kg/day) respectively in terms of AUC. No carcinogenic risk, relevant to man, was

identified in the mouse (up to 120 mg/kg/day) and in the rat (up to 240 mg/kg/day), 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.

Page 11 of 12

In carcinogenicity studies, amisulpride was administered in the diet of mice and rats for up to two

years. Treatment of mice was associated with increases in malignant mammary gland tumours and

pituitary adenomas in females at all dose levels, but there was no tumourigenic response in males

(doses were equivalent to 0.1, 0.2 and 0.5 times the maximum human dose of 1200 mg/day on a

body surface area basis). Treatment of rats resulted in increased incidences of malignant mammary

gland

tumours

both

sexes,

malignant

pituitary

tumours

adrenal

medullary

phaeochromocytomas in males, and malignant pancreatic islet cell tumours in both sexes, at doses

achieving

lower

systemic

drug

exposure

(plasma

AUC)

than

humans

maximal

recommended dose. Increases in mammary gland, pituitary, adrenal and pancreatic endocrine

tumours in rodents have been reported for other antipsychotic medicines, and are considered to

result from increased prolactin secretion.

The relevance of prolactin-mediated endocrine tumours in rodents for human risk is unknown. In

clinical trials, amisulpride substantially elevated plasma prolactin concentrations, although to date

neither

clinical

epidemiological

studies

have

shown

association

between

chronic

administration of neuroleptic medicines and mammary tumourigenesis. However, since tissue

culture experiments indicate that about one-third of human breast cancers are prolactin-dependent

in vitro, amisulpride should be used cautiously in patients with previously-detected breast cancer or

in patients with pituitary tumours (see section 4.3).

Amisulpride showed no genotoxicity in in vitro tests for bacterial gene mutation, or in in vitro and in

vivo tests for clastogenic activity.

Male rat fertility was unaffected by an amisulpride oral dose resulting in systemic drug exposure

(plasma AUC) similar to that in humans, when treatment was carried out prior to mating. Female rat

mating was reduced by concurrent amisulpride treatment, but it was normalised within days of

cessation of dosing with overall fertility being unaffected, although some adverse effects were

observed (see section 4.6).

6. Pharmaceutical Particulars

6.1

List of excipients

SULPRIX Tablets contain the following excipients:

Lactose monohydrate

Cellulose microcrystalline

Sodium starch glycolate

Hypromellose

Magnesium stearate

Additionally, SULPRIX 400 mg Film-coated Tablets also contain the following excipients in its film

coat:

Titanium dioxide

Macrogol 400

SULPRIX is gluten free.

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

SULPRIX 50 mg, 100 mg and 200 mg Tablets: 2 years.

SULPRIX 400 mg Film-coated Tablets: 3 years.

Page 12 of 12

6.4

Special precautions for storage

Store at or below 25°C.

6.5

Nature and contents of container

SULPRIX 50 mg and 100 mg Tablets: Blister packs of 30, 50, 60, 90 or 100 tablets.

SULPRIX 200 mg Tablets: Blister packs of 50, 60, 90 or 100 tablets.

SULPRIX 400 mg Film-coated Tablets: Blister packs of 50, 60, 90 or 100 tablets.

Not all pack sizes and strengths may be marketed in New Zealand.

6.6

Special precautions for disposal

Not applicable.

7. Medicines Schedule

Prescription Medicine

8. Sponsor Details

Mylan New Zealand Ltd

PO Box 11183

Ellerslie

AUCKLAND

Telephone 09-579-2792

9. Date of First Approval

24 April 2014

10. Date of Revision of the Text

5 May 2020

Sections updated

Summary of changes

Added sleep apnoea.

Added ADR Somnambulism.

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