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AMISULPRIDE 200MG 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. What you need to know before you take Amisulpride
3. How to take Amisulpride
4. Possible side effects
5. How to store Amisulpride
6. Contents of the pack and other information

1

What Amisulpride is and what it is
used for

Amisulpride contains the active substance
amisulpride. It 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
illness 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- becoming withdrawn and subdued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

What you need to know before you
take Amisulpride

Do not take Amisulpride
if you are/have
• allergic to amisulpride or any of the other
ingredients of this medicine (listed in section 6).
• breast cancer or something called
“prolactin-dependent tumour”
• a tumour on the adrenal gland
• a child before the onset of puberty
• breast-feeding
• taking levodopa: a medicine to treat Parkinsonʼs
disease

Warnings and Precautions
Talk to your doctor or pharmacist before taking
Amisulpride if you are/have
• developing fever, faster breathing, excessive
sweating, reduced consciousness or stiff
muscles. See also section 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
Older people are more likely to get low blood
pressure or feel sleepy during therapy with
Amisulpride. A small increase in the number of
deaths of older people with dementia has been
reported for patients taking antipsychotics
compared to those not receiving antipsychotics.
• Parkinsonʼs disease
• any involuntary or abnormal movements
especially of the tongue, mouth and face while
taking this medicine
• a low number of white blood cells, so called
agranulocytosis. This means that you may get
infections more easily than usual. A medical
specialist, haematologist, should be consulted if
this occurs.
• frequent unexplained infections such as fever,
severe chills, sore throat or mouth ulcers. These
could be signs of a blood problem (leucopenia,
neutropenia) and might require the consultation of
a doctor specialized in haematology.
• 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”
• 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
Other medicines and Amisulpride
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
The following medicines must not be used with
Amisulpride.
• levodopa: a medicine to treat Parkinsonʼs disease
• medicines called “dopamine agonists” such as
bromocriptine and ropinirole

The following medicines can particularly influence or
be influenced by Amisulpride:
• medicines used to control your heart beat such as
quinidine, disopyramide, amiodarone and sotalol
• other antipsychotic medicines used for mental
problems
• medicines to treat severe pain called opiates such

as morphine or pethidine
• medicines to treat high blood pressure and heart
problems such as diltiazem, verapamil,
guanfacine and digitalis
• clonidine used for migraines, flushing or high
blood pressure
• medicines to treat malaria, such as mefloquine
• medicines which help you sleep, calm or relax
muscles, such as barbiturates and benzodiazepines
• pain-killers such as tramadol and indometacin
• narcotics and anaesthetics
• certain antihistamines used to treat allergies, such
as promethazine, astemizole and terfenadine,
which make you sleepy
Amisulpride with food, drink and alcohol
Do not drink alcohol during treatment as it can
affect the way Amisulpride works.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
• Pregnancy
Do not take Amisulpride if you are pregnant
unless your doctor has told you to. 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.
• Fertility
Treatment with [invented name] may decrease
your fertility.

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.

Amisulpride contains lactose
Lactose is a type of sugar. 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 this medicine exactly as your doctor has
told you. 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.
The recommended dose is:

Adults (and adolescents after the onset of
puperty, 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.

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.
Older people
Your doctor will need to keep a close check on you
as you are more likely to have low blood pressure or
sleepiness due to this medicine.
Patients with impaired liver function
No changes to the usual daily dose are necessary.
Patients with impaired kidney function
Your doctor may need to treat you with a lower
dose.

Use in children and adolescents Amisulpride
• must not be given to children before the onset of
puberty (see section 2 “Do not take Amisulpride”.
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• is not recommended for children and adolescents
after the onset of puberty up to the age of 18
years.

Method of administration
• Take this medicine by mouth.
• 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.

4

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines this medicine 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 serious side effects:

Not known: frequency cannot be estimated from the
available data
• combination of fever, faster breathing, sweating,
muscle stiffness and reduced consciousness
All of these could be symptoms of a severe potentially fatal - 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.
• 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
• more infections than usual
This could be because of a blood disorder called
“agranulocytosis” or a decrease in the number of
white blood cells called “neutropenia”.
Uncommon: may affect up to 1 in 100 people
• severe allergic reaction, involving:
- difficulty breathing
- low blood pressure
- swelling in the mouth, throat or face
- skin rash
- itching
• fits
Other reported side effects listed according to the
frequencies are:

Very common: may affect more than 1 in 10 people
• 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: may affect up to 1 in 10 people
• 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.
• feeling dizzy due to low blood pressure
• weight gain
Uncommon: may affect up to 1 in 100 people
• movement disorders including uncontrollable
tongue, mouth and facial movements
This may occur during or after a prolonged course
of treatment:

• high blood sugar
• slowing of the heart beat
• increased values of specific liver enzymes in the
blood

Very rare: may affect up to 1 in 10,000 people
• 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.
Not known: frequency cannot be estimated from the
available data
• in older 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
Reporting of side effects
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
You can also report side effects directly via Yellow
Card Scheme: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5

How to store Amisulpride

Keep out of the sight and reach 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.

Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help Contents ofenvironment.
to protect the the pack and other

6

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 revised in 01/2015

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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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