AMISULPRIDE 100 MG 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
Read all of this leaflet carefully before you start using 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 tablets are and what they
are used for
2. Before you take Amisulpride tablets
3. How to take Amisulpride tablets
4. Possible side effects
5. How to store Amisulpride tablets
6. Further information
1. WHAT AMISULPRIDE TABLETS ARE
AND WHAT THEY ARE USED FOR
The name of your medicine is Amisulpride
50 mg tablets, Amisulpride 100 mg tablets,
Amisulpride 200 mg tablets or Amisulpride 400
mg film-coated tablets (called Amisulpride
tablets throughout this leaflet).
The active ingredient in this medicine is
amisulpride. This belongs to a group of
medicines called ‘anti-psychotics’. It is used to
treat an illness called schizophrenia.
Schizophrenia can make you feel, see or hear
things which do not exist, have strange and
frightening thoughts, change how you act, and
make you feel alone. Sometimes people with
these symptoms may also feel tense, anxious or
depressed. Amisulpride works by improving
disturbed thoughts, feelings and behaviour. It is
used to treat schizophrenia when it starts and
also over the long term.
2. BEFORE YOU TAKE AMISULPRIDE
TABLETS
Do not take Amisulpride tablets and tell your
doctor if:
• You are allergic (hypersensitive) to
amisulpride or any of the other ingredients
of Amisulpride (listed in Section 6)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling
of your lips, face, throat or tongue
• You are pregnant, might become pregnant or
are breast-feeding (see ‘Pregnancy and
breast-feeding’ section)
• You have breast cancer or something called
‘a prolactin dependent tumour’
• You have a tumour on the adrenal gland
(called phaeochromocytoma)
• You are taking levodopa, a medicine to treat
Parkinson’s disease (see ‘Taking other
medicines’ section)
• The patient is under 18 years of age.
Do not take this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Amisulpride.
Take special care with Amisulpride tablets
Check with your doctor or pharmacist before
taking your medicine if:
• You have kidney problems
• You have Parkinson’s disease
• You have ever had fits (epileptic seizures)
• You have an unusual heart rate (rhythm)
• You have heart disease or family history of
heart problems
• Your doctor has told you that you might
have a stroke
• If you or someone else in your family has a
history of blood clots, as medicines like
these have been associated with formation of
blood clots
• You are diabetic or have been told you have
an increased risk of having diabetes
• You have a slow heart beat (less than 55
beats per minute)
• You have been told you have a low amount
of potassium in your blood.
• You are elderly. This is because elderly
people are more likely to get low blood
pressure or feel sleepy. A small increase in
the number of deaths of elderly people with
dementia has been reported for patients
taking antipsychotics compared to those not
receiving antipsychotics.
• You have a low number of white blood cells
(agranulocytosis). This means you may get
infections more easily than usual.
• You have frequent infections such as fever,
severe chills, sore throat or mouth ulcers.
These could be signs of a blood problem
called “leucopenia”
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Amisulpride.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines. This includes medicines you buy
without a prescription, including herbal medicines.
This is because Amisulpride can affect the way
some other medicines work. Also some
medicines can affect the way Amisulpride works.
In particular, do not take this medicine, and tell
your doctor if you are taking any of the
following medicines:
• Levodopa, a medicine to treat Parkinson’s
disease
Tell your doctor if you are taking any of the
following medicines:
• Medicines used to control your heart beat
such as quinidine, disopyramide, amiodar
one, sotalol and bepridil
• Medicines for depression or to calm
emotional and mental illness such as
pimozide, haloperidol, imipramine,
thioridazine, lithium and sultopride
• Medicines for severe pain called opiates
such as morphine, pethidine or methadone
• Medicines for high blood pressure and

migraine such as clonidine, diltiazem and
verapamil, guanfacine and digitalis
• Clonidine used for migraines, flushing or
high blood pressure
• Mefloquine used for treating malaria
• Medicines which help you sleep such as
barbiturates and benzodiazepines
• Pain-killers such as tramadol and
indometacin
• Anaesthetics
• Antihistamines such as promethazine which
make you sleepy.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Amisulpride.
Taking Amisulpride tablets with food and
drink
• Swallow Amisulpride tablets with plenty of
water before a meal
• Do not drink alcohol while you are taking
Amisulpride. This is because it can affect the
way the medicine works.
Pregnancy and breast-feeding
Do not take this medicine if:
• You are breast-feeding or planning to
breast-feed.
The following symptoms may occur in newborn
babies, of mothers that have used Amisulpride
tablets in the last trimester (last three months of
their pregnancy): shaking, muscle stiffness
and/or weakness, sleepiness, agitation,
breathing problems, and difficulty in feeding.
If your baby develops any of these symptoms
you may need to contact your doctor.
Talk to your doctor before taking this medicine
if you are pregnant, might become pregnant or
think you may be pregnant.
Driving and using machines
You may feel less alert, drowsy or sleepy while
taking this medicine. If this happens, do not
drive or use any tools or machines.
Important information about some of the
ingredients of Amisulpride tablets
Amisulpride tablets contain lactose, a type of
sugar. If you have been told by your doctor that
you cannot tolerate some sugars, talk to your
doctor before taking this medicinal product.
3. HOW TO TAKE AMISULPRIDE
TABLETS
Always take Amisulpride tablets exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets whole or halved with a
drink of water. Do not chew your tablets
• Take before a meal
• If you feel the effect of your medicine is too
weak or too strong, do not change the dose
yourself, but ask your doctor
• If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.
How much to take
The amount of Amisulpride you take will
depend on your illness. Follow your doctor’s
instructions carefully.
Adults
The usual dose is between 50 mg and 800 mg
each day.
Your doctor may start you on a lower dose if
necessary.
If necessary your doctor can prescribe up to
1200 mg each day.
Doses up to 300 mg each day can be taken as a
single dose. Take the dose at the same time each
day.
Doses above 300 mg should be taken as half in
the morning and half in the evening.
Elderly
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.
People with kidney problems
Your doctor may need to give you a lower dose.
Children under 18 years of age
Amisulpride should not be given to children
under 18 years of age.
If you take more Amisulpride tablets than
you should
If you take more tablets than you should, tell a
doctor or go to a hospital casualty department
straight away. Take the medicine pack with you.
This is so the doctor knows what you have
taken. The following effects may happen:
feeling restless or shaky, rigid muscles, low
blood pressure, feeling drowsy or sleepy which
could lead to a loss of consciousness.
If you forget to take Amisulpride tablets
If you forget a dose, take it as soon as you
remember it. However, if it is nearly time for
the next dose, skip the missed dose.
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Amisulpride tablets
Keep taking Amisulpride until your doctor tells
you to stop. Do not stop taking Amisulpride just
because you feel better. If you stop, your illness

may get worse or come back. Unless your
doctor tells you otherwise, Amisulpride should
not be stopped suddenly. Stopping treatment
suddenly may cause withdrawal effects such as:
• Feeling or being sick
• Sweating
• Difficulty sleeping or feeling very restless
• Muscle stiffness or unusual body
movements
• Your original condition may come back.
Blood Tests
Taking Amisulpride may affect the results of
some blood tests. These include tests to measure
the hormone called ‘prolactin’ and liver tests. If
you are going to have a blood test, it is
important to tell your doctor you are taking
Amisulpride.
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 tablets and see a
doctor or go to a hospital straight away if:
• You have a high temperature, sweating, stiff
muscles, fast heartbeat, fast breathing and
feel confused, drowsy or agitated. These
could be the symptoms of a serious but rare
side effect called ‘neuroleptic malignant
syndrome’
• You have an unusual heart rate, very fast
heart rate or chest pain which could result in
a heart attack or life-threatening heart
disorder.
• You have 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.
• You get more infections than usual. This
could be because of a blood disorder
(agranulocytosis) or a decrease in the
number of white blood cells (neutropenia).
Uncommon (affects less than 1 in 100 people)
• You have an allergic reaction. The signs may
include: an itchy, lumpy rash, swallowing or
breathing problems, swelling of your lips,
face, throat or tongue
• You have a fit (seizure).
Tell your doctor as soon as possible if you
have any of the following side effects:
Very Common (affects more than 1 in 10
people)
• Trembling, muscle stiffness or spasm, slow
movement, producing more saliva than usual
or feeling restless.
Common (affects less than 1 in 10 people)
• Movements that you cannot control, mainly
of the arms and legs.
(These symptoms can be reduced if your doctor
lowers your dose of Amisulpride or prescribes
an additional medicine).
Uncommon (affects less than 1 in 100 people)
• Movements that you cannot control, mainly
of the face or tongue.
Other side effects include:
Common (affects less than 1 in 10 people)
• Difficulty sleeping (insomnia) or feeling
anxious or agitated
• Feeling drowsy or sleepy
• Constipation, feeling or being sick, dry
mouth
• Putting on weight
• Unusual production of breast milk in women
and men, breast pain
• Menstrual period stops
• Breast enlargement in men
• Difficulty in getting or maintaining an
erection, or in ejaculating
• Feeling dizzy (which can be due to low
blood pressure).
Uncommon (affects less than 1 in 100 people)
• Slowing of the heart beat
• High blood sugar (hyperglycaemia)
Tell your doctor or pharmacist if any of the side
effects get serious or lasts longer than a few
days, or if you notice any side effects not listed
in this leaflet.
Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively
you can call Freephone 0808 100 3352
(available from 10 a.m. to 2 p.m. Mondays to
Fridays) or fill in a paper form available from
your local pharmacy.
5. HOW TO STORE AMISULPRIDE
TABLETS
Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any
special storage conditions.
Do not use Amisulpride after the expiry date,
which is stated on the carton and blisters after
'EXP'. The expiry date refers to the last day of
that month.
Do not use Amisulpride if you notice that the
tablets become discoloured.
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 tablets contain
The Amisulpride 50 mg tablets contain 50 mg of
the active substance, amisulpride.
The Amisulpride 100 mg tablets contain 100 mg
of the active substance, amisulpride.
The Amisulpride 200 mg tablets contain 200 mg
of the active substance, amisulpride.
The Amisulpride 400 mg film-coated tablets
contain 400 mg of the active substance,
amisulpride.

The other ingredients in Amisulpride are:
lactose monohydrate, methylcellulose, sodium
starch glycolate (Type A), microcrystalline
cellulose, magnesium stearate.
Amisulpride 400 mg tablets also contain
Eudragit (E100), titanium dioxide (E171), talc,
magnesium stearate, Macrogol 6000.
What Amisulpride tablets look like and
contents of the pack
Amisulpride 50 mg tablets are white, round,
biconvex tablets with a break line on one side
and embossed with A50 on the other side. They
are available in blister packs of 60 tablets.
Amisulpride 100 mg tablets are white, round,
flat tablets with break line on one side and
embossed with A100 on the other side. They are
available in blister packs of 60 tablets.
Amisulpride 200 mg tablets are white, round,
flat tablets with break line on one side and
embossed with A200 on the other side. They are
available in blister packs of 60 tablets.
Amisulpride 400 mg tablets are white to off
white, film-coated, oblong tablets with break
line on one side. They are available in blister
packs of 60 tablets.
Marketing authorisation holder and
manufacturer
Marketing Authorisation Holder
DOUBLE-E PHARMA LTD.
7th Floor, Hume House, Ballsbridge
Dublin 4
Ireland
Manufacturer
Laboratories BTT
ZI de Krafft
67150 Erstein
France
Distributed by:
Creo Pharma Ltd
Felsted Business Centre, Felsted
Essex CM6 3LY, UK
This leaflet does not contain all the information
about your medicine. If you have any questions
or are not sure about anything, ask your doctor
or pharmacist.
This leaflet was last revised in 01/2013

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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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