AMISULPRIDE 50MG TABLETS

Active substance: AMISULPRIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Amisulpride 50 mg Tablets
Amisulpride 100 mg Tablets
Amisulpride 200 mg Tablets
Amisulpride 400 mg Film-coated Tablets

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Amisulpride

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

In this leaflet:
1. What Amisulpride is and what it is used for
2. Before you take Amisulpride
3. How to take Amisulpride
4. Possible side effects
5. How to store Amisulpride
6. Further information

1

What Amisulpride is and what it is
used for

Amisulpride belongs to a group of medicines called
antipsychotics.

Amisulpride is used to treat schizophrenia, when it
starts and also over the long term. Symptoms of this
disorder include:
• so called positive symptoms:- hallucinations, such as
feeling, seeing or hearing things which do not exist
- strange and/or frightening thoughts
- changes in your behaviour, which can be
aggressive
• so called negative symptoms:
- becoming withdrawn and subdued

2

Before you take Amisulpride

Do not take Amisulpride
if you are/have
• allergic (hypersensitive) to amisulpride or any of
the other ingredients as listed under section “6
Further Information”.
• breast cancer or something called
“prolactin-dependent tumour”
• a tumour on the adrenal gland
• under 15 years old
• breast-feeding
• taking any of the following medicines:
- levodopa: a medicine to treat Parkinsonʼs disease
- medicines which may cause severe heart
beat disorders - See below under “Taking
other medicines”, first bullet point

Take special care with Amisulpride
Inform your doctor or pharmacist if you are/have
• developing fever, faster breathing, excessive
sweating, reduced consciousness or stiff
muscles. See also chapter 4, first paragraph
• high blood sugar levels - diabetes mellitus - or
are at risk of developing it.
If you do, your doctor may check your blood sugar
levels while you are taking Amisulpride.
• kidney function disorder
See section “3 How to take Amisulpride”
• ever suffered from fits
If you have epilepsy you may experience more
frequent fits during treatment with Amisulpride.
Your doctor will need to monitor you more closely.
• over 65 years old
Elderly people are more likely to get low blood
pressure and feel sleepy during therapy with
Amisulpride.
• Parkinsonʼs disease
• any involuntary or abnormal movements
especially of the tongue, mouth and face while
taking this medicine
• heart disease or a family history of heart
problems, such as heart failure or irregular heart
beat, especially an abnormality known as
“prolonged QT-interval”
• heart beat below 55 beats per minute
• electrolyte imbalance, especially a low amount
of potassium in your blood
• had a stroke previously or are at risk of stroke
• or someone else in your family has a history of
blood clots, as medicines like these have been
associated with formation of blood clots

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.

The following medicines can particularly influence or
be influenced by Amisulpride:
• medicines which may cause severe heart beat
disorders must not be used with Amisulpride.
These include:
- medicines to treat irregular heart beats, such
as quinidine, disopyramide, procainamide,
flecainide, propafenone, amiodarone, sotalol
and bepridil
- medicines to treat bacterial infections such as
erythromycin given by injection, sparfloxacin
and pentamidine
- medicines to treat fungal infections with active
substance names ending with “azole”
- medicines to treat malaria, such as halofantrine
- cisapride: a medicine to treat stomach and/or
bowel problems
- thioridazine: a medicine to treat mental disorders
- vincamine given by injection: a medicine to
increase the blood flow through the brain

- methadone, a medicine to treat severe pain or
to counter addiction
- sultopride, a medicine to treat mental disorders
- levodopa: a medicine to treat Parkinsonʼs disease
• medicines which can lower your heart beat
such as:
- medicines to treat high blood pressure, heart
disease or other illnesses, so called beta-blockers,
with active substance names ending with “olol”
- diltiazem, verapamil, guanfacine: medicines
to treat high blood pressure and heart disorders
- clonidine: a medicine to treat high blood
pressure and high eye pressure
- digitalis: a medicine to improve the pumping
strength of the heart
• medicines which may lower potassium levels
in your blood such as:
- water tablets, such as hydrochlorothiazide or
bendrofluazide
- some laxatives
- glucocorticoids: medicines used to treat
severe asthma and other inflammatory disorders
and to prevent organ transplant rejection
- tetracosactide: a medicine used for diagnostic
purposes and to treat a severe form of epilepsy
- amphotericin B given by injection: a medicine
to treat fungal infections
- other medicines to treat mental or anxiety
disorders belonging to the same group of
medicines as Amisulpride does, such as
pimozide and haloperidol
- medicines to treat depression, such as
imipramine and lithium
• medicines which affect the brain or spinal
cord, such as:
- narcotics and anaesthetics
- pain killers
- certain antihistamines: medicines to treat
allergies, such as astemizole and terfenadine
- barbiturates and benzodiazepines: medicines
which calm, induce sleep or relax muscles
- medicines to regulate your blood pressure

Taking Amisulpride with food and drink
Do not drink alcohol during treatment as it can
affect the way Amisulpride works.

Pregnancy and breast-feeding
• Pregnancy
Do not take Amisulpride if you are pregnant
unless your doctor has told you to. Inform your
doctor immediately if you are pregnant or think
you may be.
The following symptoms may occur in newborn
babies, of mothers who have used Amisulpride in
the last trimester (last three months of their
pregnancy): shaking, muscle stiffness and/or
weakness, sleepiness, agitation, breathing
problems, and difficulty feeding. If your baby
develops any of these symptoms you may need to
contact your doctor.
• Breast-feeding
You must not take Amisulpride when breast-feeding.

Ask your doctor or pharmacist for advice before
taking any medicine.

Driving and using machines
Only drive or operate machines if your doctor has
approved it. This will depend upon how this therapy
affects you, because Amisulpride may impair your
mental alertness and make you feel drowsy or sleepy.

Important information about some of the
ingredients of Amisulpride
Amisulpride contains lactose. If you have been told
by your doctor that you have an intolerance to some
sugars, contact your doctor before taking Amisulpride.

3

How to take Amisulpride

Always take Amisulpride exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.

Your doctor will tell you how many Amisulpride
tablets/film-coated tablets you should take and
how long you should continue to take them.

Adults (and adolescents from 15 years of age, if
treatment is absolutely required)
If you suffer from positive symptoms, the usual dose
is between 400 mg and 800 mg amisulpride daily,
and will be adjusted individually by your doctor
depending on the nature and severity of your illness.
The maximum daily dose is 1,200 mg.
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If you suffer from both positive and negative
symptoms, your doctor will adjust your dose individually
so that there is adequate control of the positive
symptoms. To maintain treatment, your doctor will
use the lowest possible dose that is effective for you.

If you suffer from negative symptoms, the usual
dose is between 50 mg and 300 mg amisulpride
daily, and will be adjusted individually by your doctor
depending on the nature and severity of your illness.

Children and adolescents
Efficacy and safety of amisulpride in children and
adolescents under 18 years of age have not been
established. If absolutely required treatment of
adolescents from 15 to 18 years of age must be
initiated and performed by a physician experienced in
treating schizophrenia in this age group; children and
adolescents under 15 years of age must not take
Amisulpride (see section 2 “Do not take Amisulpride”).
Patients with impaired kidney function
Your doctor will treat you with a lower dose, half or a
third of the usual daily dose, depending on the
impairment grade of your kidney.

Patients with impaired liver function
No changes to the usual daily dose are necessary.

Method of administration
• Swallow the tablets with a glass of water.
• You can take them during or between meals.
• Doses up to 300 mg amisulpride per day can be
taken as a single dose, preferably at the same
time each day.
• Doses above 300 mg amisulpride should be taken
as half in the morning and half in the evening.

If you take more Amisulpride than you should
Contact your doctor or a hospital at once. Always
take the tablets/film-coated tablets (400 mg only),
leaflet and/or carton with you so the doctor will know
what you have taken. Immediate medical care is
necessary if the following signs occur: drowsiness,
sedation, loss of consciousness, unusual body
movements, rigid muscles and low blood pressure.
If you forget to take Amisulpride
Continue treatment by taking your next dose at the
usual time. Do not take a double dose to make up
for a forgotten dose.

If you stop taking Amisulpride
Do not stop taking Amisulpride unless advised by
your doctor, as this may harm the success of therapy.
Stopping treatment suddenly may cause withdrawal
symptoms such as nausea, vomiting, sleeplessness,
rigid muscles, unusual body movements and
recurrence of the symptoms of your illness.
To avoid such symptoms, it is important to reduce
the dose gradually according to your doctorʼs
instructions.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Amisulpride can cause side
effects, although not everybody gets them.

Stop taking Amisulpride and contact your doctor
immediately or go to the nearest hospital if you
notice any of the following:
• combination of fever, faster breathing, sweating,
muscle stiffness and reduced consciousness
All of these could be symptoms of a severe
disorder called “neuroleptic malignant syndrome”.
• irregular heart beat, very fast heart rate or chest pain
This could result in a heart attack or
life-threatening heart disorder.
• severe allergic reaction, involving:
- difficulty breathing
- low blood pressure
- swelling in the mouth, throat or face
- skin rash
- itching
• fits

Reported side effects listed according to the
frequencies are:

Very common, occurs in more than 1 per 10 users
• trembling
• muscle stiffness or spasm
• slow movement
• producing more saliva than usual
• feeling restless
Consult your doctor if this occurs. These
symptoms are generally mild and can be reduced
by lowering your Amisulpride dose, or by
treatment with an additional medicine.

Common, occurs in 1 to 10 per 100 users
• muscle cramps, mainly of the neck, eyes and jaws
Consult your doctor if this occurs. These effects
are reversible by adequate treatment with an
additional medicine.
• feeling sleepy
• difficulty sleeping
• feeling anxious or agitated
• difficulty having orgasms
• constipation
• nausea and vomiting
• dry mouth
• increased values of a hormone called prolactin in
your blood, which can lead to
- unusual production of breast milk in women
and men
- menstrual period stopping or irregular
menstrual periods
- breast enlargement in men
- breast pain or breast enlargement
- prolactin-dependent tumour
- difficulty in getting or maintaining an erection or
in ejaculating
These symptoms disappear after ending therapy
with Amisulpride.
• low blood pressure
• weight gain

Uncommon, occurs in 1 to 10 per 1,000 users
• movement disorders including uncontrollable
tongue, mouth and facial movements
This may occur during or after a prolonged course
of treatment:
• fits
• high blood sugar
• slowing of the heart beat
• increased values of specific liver enzymes in the
blood
• allergic reaction

Very rare, occurs in less than 1 per 10,000 users
• discontinuation symptoms such as
- nausea, vomiting and sleeplessness
- recurrence of the symptoms of your disorder
- involuntary or abnormal movements especially
of the tongue, mouth and face
These occur when you suddenly stop taking
Amisulpride, especially if you have taken high doses
of this medicine.

Frequency unknown, according to the available data
• so called “neuroleptic malignant syndrome”, see
also first paragraph in this chapter
• heart arrest, specific heart rhythm disorders,
sudden unexplained death
• blood clots in the veins especially in the legs
(symptoms include swelling, pain and redness in
the leg), which may travel through blood vessels to
the lungs causing chest pain and difficulty in breathing
If you notice any of these symptoms seek medical
advice immediately.
• in elderly people with dementia, a small increase
in the number of deaths has been reported for
patients taking antipsychotics compared with
those not receiving antipsychotics
• swelling of the skin associated with pain, redness
and itching

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5

How to store Amisulpride

Keep out of the reach and sight of children.

Do not use Amisulpride after the expiry date which is
stated on the carton and on the blister. The expiry
date refers to the last day of that month.

This medicinal product does not require any special
storage conditions.

Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6

Further information

What Amisulpride contains
The active substance is amisulpride.

Amisulpride 50 mg tablets:
Each tablet contains 50 mg amisulpride.

Amisulpride 100 mg tablets:
Each tablet contains 100 mg amisulpride.

Amisulpride 200 mg tablets:
Each tablet contains 200 mg amisulpride.

Amisulpride 400 mg film-coated tablets:
Each film-coated tablet contains 400 mg amisulpride.

The other ingredients are:
Amisulpride 50 mg, 100 mg and 200 mg tablets:
Lactose monohydrate, magnesium stearate,
methylcellulose, microcrystalline cellulose, sodium
starch glycolate (type A)

Amisulpride 400 mg film-coated tablets:
• Tablet core: Lactosemonohydrate, magnesium
stearate, methylcellulose, microcrystalline
cellulose, sodium starch glycolate (type A)
• Tablet coating: Macrogol 6000, magnesium
stearate, methacrylate copolymer (Eudragit
E100), talc, titanium dioxide (E171)

What Amisulpride looks like and contents of the pack
Amisulpride 50 mg tablets are white, round with 6 mm
diameter and rounded on the upper and lower side. They
have a score line and can be divided into equal halves.

Amisulpride 100 mg tablets are white, round with
8 mm diameter and flat. They have a score line and
can be divided into equal halves.

Amisulpride 200 mg tablets are white, round with
11 mm diameter and flat. They have a score line and
can be divided into equal halves.

Amisulpride 400 mg film-coated tablets are white to
off white, 18 mm long and 8 mm wide. They have a
score line and can be divided into equal halves.

Amisulpride 50 mg, 100 mg and 200 mg tablets are
available in blister packs of 10, 12, 14, 20, 21, 30,
42, 50, 60, 98, 100, 150, 198 and 200 (bundled
package 2x100) tablets.

Amisulpride 400 mg film-coated tablets are available
in blister packs of 10, 12, 14, 20, 21, 30, 42, 50, 60,
98, 100, 150, 198 and 200 (bundled package 2x100
film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer
Lek Pharmaceuticals D.D., Ljubljana, Slovenia or
Lek S.A., Warsaw, Poland or Salutas Pharma GmbH,
Barleben, Germany or Salutas Pharma GmbH
(Gerlingen), Gerling, Germany.

This leaflet was last approved in 02/2012 (to be
amended after approval).
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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