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AMISULPRIDE 50 MG TABLETS

Active substance(s): AMISULPRIDE

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Package leaflet: Information for the patient

Amisulpride
50 mg, 100 mg, 200 mg
tablets
Amisulpride 400 mg
film-coated tablets
Amisulpride

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• 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
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is 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 Tablets contain amisulpride
and belongs to a group of medicines called
antipsychotics which help to control the symptoms
of a mental illness called schizophrenia.
Symptoms include:
• delusions (having strange or unusual thoughts)
• hallucinations (seeing or hearing things that are
not there)
• being suspicious or aggressive for no apparent
reason (these are so called "positive symptoms")
• becoming withdrawn and subdued (these are so
called "negative symptoms").
Amisulpride can be used at the start of and for the
long term treatment of schizophrenia.
2. What you need to know before you take
Amisulpride
Do not take Amisulpride if you:
• are allergic to amisulpride or any of the other
ingredients of this medicine (listed in Section 6).
Signs of an allergic reaction may include a rash,
difficulty swallowing or breathing, swelling of the
lips, face, throat or tongue
• have breast cancer or something called a
‘prolactin dependent tumour’.
• have a tumour on the adrenal gland
called phaechromocytoma.
• are breast-feeding.
• are taking levodopa (used to treat Parkinson's
disease) or medicines to treat heart rhythm
disorders, or medicines that may cause an
abnormal heart rhythm when used at the same
time as amisulpride (see “Other medicines and
Amisulpride” below)
• are under 15 years old
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.
Warnings and precautions
Talk to 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 are diabetic or have been told you have an
increased risk of developing diabetes
• you have an unusual heart rate (rhythm)
• you have heart disease or family history of heart
problems or sudden death
• you have a long QT interval or a history of this in
the family (this is a measure of the way your heart
is working and can be detected by a doctor using
an electrocardiogram)
• you had a stroke previously or your doctor has
told you that you are at risk of a stroke
• 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 or someone else in your family has a history
of breast cancer, as amisulpride can affect the
risk of developing breast cancer. You should
therefore be closely monitored during treatment
with Amisulpride
• you have a slow heart beat (less than 55 beats
per minute)
• you are taking other medicines that could affect
your heart's function: check with your doctor
before taking any other medicine. See also under
headings "Do not take Amisulpride" and "Other
medicines and Amisulpride”
• you have been told you have a low amount of
potassium or magnesium 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 in patients taking antipsychotics
compared to those not receiving antipsychotics.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Amisulpride.

Other medicines and Amisulpride
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines
including medicines obtained without a prescription.
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:
• bromocriptine or ropinirole (medicines used to
treat Parkinson’s disease)
• levodopa, a medicine to treat Parkinson’s disease
• medicines to treat heart rhythm problems (such
as quinidine, disopyramide, procainamide,
amiodarone, sotalol)
• cisapride (used to treat stomach problems)
• bepridil (used to treat angina/chest pain and
changes in heart rhythm)
• sultopride and thioridazine (for schizophrenia)
• methadone (for pain and drug abuse)
• halofantrine (to prevent malaria)
• pentamidine (to treat infections in HIV patients)
• erythromycin by injection or
sparfloxacin (antibiotics)
• medicines for fungal infections, such
as clotrimazole
• vincamine by injection (used for various
brain disorders)
Tell your doctor if you are taking any of the
following medicines:
• medicines used to treat high blood pressure
or other heart problems, that could slow your
heart rate down. These include beta-blockers
(such as nebivolol or bisoprolol, diltiazem,
verapamil, clonidine, guanfacine, digoxin or
digoxin-like medicines
• medicines which can cause low potassium
levels including diuretics ("water tablets"),
some laxatives, amphotericin B (by
injection), glucocorticoids (used for
conditions such as asthma or rheumatoid
arthritis) and tetracosactide (may be used in
clinical investigations)
• medicines used to treat schizophrenia such as
pimozide or haloperidol
• imipramine or lithium (used to treat depression)
• some antihistamines such as astemizole and
terfenadine (for allergies)
• other anti-psychotic medicines used for mental
health problems
• medicines for severe pain called opiates such as
morphine or pethidine
• medicines which help you sleep such as
barbiturates and benzodiazepines
• pain-killers such as tramadol and indomethacin
• anaesthetics
• antihistamines (for allergies) which make you
sleepy, such as promethazine.
Amisulpride with alcohol
Do not drink alcohol while you are taking
Amisulpride. This is because Amisulpride can
increase the effects of alcohol.
Pregnancy and breast-feeding
Do not take this medicine if you are breast-feeding
or planning to breastfeed.
If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor for
advice before taking this medicine.
The following symptoms may occur in newborn
babies of mothers that have used Amisulpride in
the last trimester (last three months of 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.
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.
Amisulpride tablets contain lactose.
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.
3. How to take Amisulpride
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Adults
If you suffer from positive symptoms, the
recommended dose is between 400 mg and
800 mg daily, and will be adjusted by your doctor
depending on the nature and severity of your
illness and your kidney function. The maximum
daily dose is 1,200 mg.
If you suffer from both positive and negative
symptoms, your doctor will adjust your dose 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 mostly negative symptoms,
the recommended dose is between 50 mg and
300 mg daily, and will be adjusted by your doctor
depending on the nature and severity of your
illness and your kidney function.

Patients over 65 years:
Amisulpride can cause sedation (drowsiness)
or a fall in blood pressure, and is not generally
recommended as there is only limited experience
in this age group.
Use in 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 these tablets (see section 2 “Do not
take Amisulpride”).
Patients with kidney problems
Your doctor will normally give you a lower dose.
This may be half or a third of the usual daily dose,
depending on how well your kidneys are working.
How to take this medicine:
• Swallow the tablets with a glass of water.
• You can take them during or between meals.
• Doses up to 300 mg per day can be taken as a
single dose preferably at the same time each day.
• Doses above 300 mg should be taken as half in
the morning and half in the evening.
• The 100 mg, 200 mg and 400 mg tablets can be
divided into equal doses.
If you take more Amisulpride than you should
Contact your doctor or hospital immediately. Take
the tablets, leaflet and/or carton with you 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
Take it as soon as you remember. 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
Keep taking your tablets until your doctor tells
you to stop. Do not stop taking them just because
you feel better. If you stop, your illness may get
worse or come back. Unless your doctor tells
you to, stopping treatment suddenly may cause
withdrawal effects such as feeling sick, vomiting,
sweating, difficulty sleeping, extreme restlessness,
muscle stiffness or abnormal movements, or your
original condition may come back. To avoid such
effects it is important to reduce the dose gradually
according to your doctors instructions.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Amisulpride and see a doctor or go
to a hospital immediately if you notice any of the
following side effects:
Uncommon (may affect up to 1 in 100 people)
• A serious allergic reaction. The signs may include
an itchy, lumpy rash, difficulty swallowing or
breathing, swelling of your lips, face, throat
or tongue
• A fit (seizure)
Not known (frequency cannot be estimated from
the available data)
• 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’
• An unusual heart rate, very fast heart rate or chest
pain which could result in a heart attack or lifethreatening 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. If you notice any of these signs, seek
medical advice immediately.
• You get more infections than usual, causing
fever, sore throat or mouth ulcers. This could be
because of a decrease in the number, or lack of
white blood cells
• Benign (non-cancerous) pituitary tumour such as
prolactinoma.
• Feeling unwell, confused or weak, feeling sick
(nausea), loss of appetite, feeling irritable. This
could be signs of an illness called syndrome of
inappropriate antidiuretic hormone secretion
(SIADH).
Tell your doctor as soon as possible if you have
any of the following side effects:
Very common (may affect more than 1 in 10 people)
• Trembling, muscle stiffness or spasm, slow
movement, producing more saliva than usual or
feeling restless.
Common (may affect up to 1 in 10 people)
• Movements that you cannot control, mainly of
the head, neck, jaw or eyes.
Uncommon (may affect up to 1 in 100 people)
• Movements that you cannot control, mainly of
the face or tongue

Other side effects include:
Common (may affect up to 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
• Low blood pressure, which may cause you to
feel dizzy
• Increased blood levels of prolactin (a protein),
which would be seen in a test and may cause:
-- Breast pain or enlargement, unusual production of
breast milk (these can occur in women and men)
-- Menstrual problems such as missed periods
-- Sexual effects such as problems reaching orgasm
or difficulty in getting or maintaining an erection
-- Unusual growth in the pituitary gland
Uncommon (may affect up to 1 in 100 people)
• Slowing of the heart beat
• High blood sugar (hyperglycaemia)
• Increase in liver enzymes, which would be seen in
a blood test
Rare (may affect up to 1 in 1,000 people)
• Withdrawal symptoms after stopping treatment
of high doses of amisulpride. These may include
feeling or being sick difficulty sleeping, extreme
restlessness, muscle stiffness or abnormal
movements, or your original illness may come back.
Not known (frequency cannot be estimated from
the available data)
• Withdrawal symptoms seen in newborn babies
where the mother has taken this medicine.
• Raised levels of certain fats (triglycerides) and
cholesterol in the blood
• Confusion
• Low levels of sodium in your blood which may be
seen in blood tests (hyponatraemia).
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 the Yellow Card Scheme at:
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 this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the carton and blister after ‘EXP’.
The expiry date refers to the last day of that month.
This medicine does not require any special
storage conditions.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Amisulpride tablets contain:
The active substance is amisulpride.
Each 50 mg tablet contains 50 mg amisulpride.
Each 100 mg tablet contains 100 mg amisulpride.
Each 200 mg tablet contains 200 mg amisulpride.
Each 400 mg tablet contains 400 mg amisulpride.
The other ingredients are lactose monohydrate
(see section 2, ‘Amisulpride tablets contain
lactose’), microcrystalline cellulose, sodium
starch glycolate (Type A), hypromellose (E464),
magnesium stearate.
The film-coating contains hypromellose, titanium
dioxide (E171), macrogol 400 (400 mg only).
What Amisulpride tablets looks like and contents
of the pack
50mg: White round tablet with ‘AA 50’ on one side
and ‘G’ on the reverse, 6 mm in diameter.
100 mg: White round tablet with ‘AMI’ breakline
‘100’ on one side and ‘G’ on the reverse, 7.5 mm
in diameter.
200 mg: White round tablet with ‘AMI’ breakline
‘200’ on one side and ‘G’ on the reverse 10.0 mm
in diameter.
400 mg: White film coated, capsule shaped tablet,
embossed with "AS 400" on one side and a breakline on the reverse, dimensions 18 mm x 7.7 mm.
Amisulpride is available in:
Blister packs containing the following number
of tablets: 12 (50mg only,) 20, 30, 50, 60, 90, 100,
120 (200mg only), 150 tablets (200mg only)
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan,
Potters Bar,
Hertfordshire,
EN6 1TL,
UK
Manufacturer
Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13,
Ireland

This leaflet was last revised in 01/2016

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