New Zealand - English - Medsafe (Medicines Safety Authority)
Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
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
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
What Sulprix is used
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
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
This medicine is available only with
a doctor’s prescription.
Before you take
When you must not take
Do not take Sulprix if you have an
any medicine containing
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
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
halofantrine, a medicine used to
levodopa, a medicine used in
antipsychotic medicines such as
thioridazine and sultopride
methadone, a medicine used to
treat pain or addiction
cisapride, a medicine used to
vincamine, an antihypertensive
Do not take this medicine if you
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
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
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
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
If you are not sure whether you
should start taking this medicine,
talk to your doctor.
Before you start to take
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
kidney or liver disease
Page 2 of 4
history of seizures
problems with the heart and
blood vessels, low blood
history of blood clots
diabetes, history of high blood
sugar levels (hyperglycaemia)
or family history of diabetes
mood changes or suicidal
risk factors for stroke
history or family history of
unusual muscle tone
tumour of pituitary gland
fever or high bod temperature
Tell your doctor if you are
pregnant or plan to become
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
Some medicines may interfere with
Sulprix. These include:
medicines used to treat
irregular heart rhythm such as
amiodarone, sotalol, digitalis
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,
imipramine, lithium and
diuretics also known as fluid
glucocorticosteroids such as
diagnostics drugs such as
medicines taken for anxiety,
depression or to help you sleep,
such as barbiturates and
some strong pain killers
some antihistamines, used to
treat allergies, which cause
some medicines taken to
control blood pressure
guanfacine, a medicine used to
treat attention deficit
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
Your doctor and pharmacist have
more information on medicines to
be careful with or avoid while taking
How to take Sulprix
Follow all directions given to you
by your doctor or pharmacist
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
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
Sulprix tablets should be taken
once or twice a day preferably
How long to take it
Continue taking your medicine
for as long as your doctor tells
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
Do not take a double dose to
make up for the dose that you
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
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
If you become pregnant while
taking this medicine, tell your
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
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
thoughts or talk about death or
thoughts or talk about self-harm
or doing harm to others
any recent attempts of self-
increase in aggressive
behaviour, irritability or agitation
depressed mood or worsening
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
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
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,
movements and reduced levels of
Tell your doctor or pharmacist as
soon as possible if you do not
feel well while you are taking
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
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
Ask your doctor or pharmacist to
answer any questions you may
Tell your doctor or pharmacist if
you notice any of the following
and they worry you:
nausea and vomiting
problems with orgasm.
The above list includes the more
common side effects of your
Tell your doctor as soon as
possible if you notice any of the
falling, feeling faint or dizzy on
unusual movements, including
trembling and shaking or the
hands and fingers
restlessness or difficulty sitting
stiffness of the arms and legs
reduced or slow body
difficulty passing urine
unusual secretion of breast milk
absence of menstrual periods
and changes in the regularity of
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
The above list includes serious side
effects that may require medical
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
seizures, fits or convulsions
uncontrollable twitching or
jerking movements of the
tongue, mouth, cheeks, or jaw
which may progress to the arms
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
weakness or numbness in any
part of your body
severe pain, swelling or
discolouration in either of your
unexplained infections or fever
increased skin sensitivity to
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
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
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
Keep it where children cannot
A locked cupboard at least one-and-
a half metres above the ground is a
good place to store medicines.
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.
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.
Sulprix contains either 100, 200 or
400 mg of amisulpride as the active
Sulprix also contains:
sodium starch glycolate.
Additionally, the 400 mg tablets also
This medicine does not contain
If you want to know
Should you have any questions
regarding this product, please
contact your pharmacist or doctor.
Who supplies this
Sulprix is supplied in New Zealand
Mylan New Zealand Ltd,
PO Box 11183,
Telephone: (09) 579 2792
Date of Information
5 May 2020
(Based on datasheet dated 5 May
Page 1 of 12
NEW ZEALAND DATA SHEET
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
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
characterised by predominant negative symptoms.
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.
Amisulpride should be used with particular caution because of a possible risk of hypotension or
Amisulpride is contra-indicated in children up to puberty as its safety has not yet been established.
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)
Since amisulpride is weakly metabolised, a dosage reduction should not be necessary (see section
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.
Children up to puberty.
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
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.
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
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
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
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
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.
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).
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
The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder, and close
supervision of high-risk patients should accompany therapy.
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
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).
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,
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 may enhance the effects of the following medicines:
CNS depressants including narcotics, anaesthetics, analgesics, sedative H
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
was observed when lithium and amisulpride were co-administered but is not regarded as clinically
A study of the effect of concomitant use of cimetidine on amisulpride excretion has not been
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-
Page 6 of 12
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.
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.
No data available. For pre-clinical fertility data refer to section 5.3.
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.
Adverse effects have been ranked under headings of frequency using the following convention: very
<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
Blood and lymphatic system disorders
Agranulocytosis (see section 4.4)
Immune system disorders
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.
Benign pituitary tumour such as prolactinoma (see sections 4.3 and 4.4)
Metabolism and nutritional disorders
Hyperglycaemia (see section 4.4), hypertriglyceridaemia and
Page 7 of 12
Hyponatraemia and syndrome of inappropriate antidiuretic hormone secretion
Insomnia, anxiety, agitation, orgasmic dysfunction
Nervous system disorders
hypersalivation, akathisia, dyskinesia. These symptoms are generally mild at
optimal dosages and partially reversible without discontinuation of amisulpride
extrapyramidal symptoms, which is dose related, remains very low in the
treatment of patients with predominantly negative symptoms with doses of
Acute dystonia (spasm torticolis, oculogyric crisis, trismus) may appear. This
is reversible without discontinuation of amisulpride upon treatment with an
anti-parkinsonian agent. Somnolence.
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.
Neuroleptic Malignant Syndrome (see section 4.4), which is a potentially fatal
Somnambulism (sleepwalking) and related behaviours including sleep-related
eating disorder have been reported with the use of atypical antipsychotic
medicines, including amisulpride.
Blurred vision (see section 4.7)
QT interval prolongation
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).
Increase in blood pressure
Venous thromboembolism, including pulmonary embolism, sometimes
and deep vein thrombosis (see section 4.4).
Respiratory, thoracic and mediastinal disorders
Nasal congestion, pneumonia aspiration (mainly in association with other
Constipation, nausea, vomiting, dry mouth
Uncommon: Hepatocellular injury
Skin and subcutaneous tissue disorders
Angioedema and urticaria
Page 8 of 12
Musculoskeletal and connective tissue disorders
Osteopenia and osteoporosis
Renal and urinary disorders
Pregnancy, puerperium and perinatal conditions
Neonatal drug withdrawal syndrome has been reported.
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/.
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.
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
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
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
Page 9 of 12
hyperactivity without affecting stereotypies. In addition, it does not induce catalepsy and it does not
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.
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%.
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
A high-carbohydrate low-fat meal (14 g protein, 8 g fat, 108 g CHO) significantly decreases the AUC,
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
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.
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.
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
phaeochromocytomas in males, and malignant pancreatic islet cell tumours in both sexes, at doses
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
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
List of excipients
SULPRIX Tablets contain the following excipients:
Sodium starch glycolate
Additionally, SULPRIX 400 mg Film-coated Tablets also contain the following excipients in its film
SULPRIX is gluten free.
SULPRIX 50 mg, 100 mg and 200 mg Tablets: 2 years.
SULPRIX 400 mg Film-coated Tablets: 3 years.
Page 12 of 12
Special precautions for storage
Store at or below 25°C.
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.
Special precautions for disposal
7. Medicines Schedule
8. Sponsor Details
Mylan New Zealand Ltd
PO Box 11183
9. Date of First Approval
24 April 2014
10. Date of Revision of the Text
5 May 2020
Summary of changes
Added sleep apnoea.
Added ADR Somnambulism.