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AMISULPRIDE 100 MG/ML ORAL SOLUTION

Active substance(s): AMISULPRIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

AMISULPRIDE 100 mg/ml ORAL SOLUTION
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 get 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 100 mg/ml Oral Solution is and what it is used for
2. Before you take Amisulpride 100 mg/ml Oral Solution
3. How to take Amisulpride 100 mg/ml Oral Solution
4. Possible side effects
5. How to store Amisulpride 100 mg/ml Oral Solution
6. Further information
1. WHAT AMISULPRIDE 100 mg/ml ORAL SOLUTION IS AND WHAT IT IS USED FOR
The name of your medicine is Amisulpride 100 mg/ml Oral Solution. Amisulpride 100 mg/ml Oral Solution contains
a medicine called 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 100 mg/ml Oral Solution 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 100 mg/ml ORAL SOLUTION
Do not take this medicine and tell your doctor if:
• You are allergic (hypersensitive) to amisulpride or any of the other ingredients of Amisulpride 100 mg/ml Oral
Solution (listed in Section 6 below) 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 used to treat Parkinson’s disease (See ‘Taking other medicines’ section)
• The patient is under 18 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 100 mg/ml Oral Solution.
Take special care with Amisulpride 100 mg/ml Oral Solution
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 ‘leukopenia’
• You or someone else in your family has a history of breast cancer
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amisulpride
100 mg/ml Oral Solution.
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 100 mg/ml
Oral Solution can affect the way some other medicines work. Also some medicines can affect the way
Amisulpride 100 mg/ml Oral Solution 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
• Drugs called ‘dopamine agonists’ such as ropinirole and bromocriptine
Tell your doctor if you are taking any of the following medicines;
• Medicines used to control your heart beat such as quinidine, disopyramide, amiodarone and sotalol
• Other anti-psychotic medicines used for mental problems
• Medicines for severe pain called opiates such as morphine or pethidine
• Mefloquine used to treat malaria
• Medicines for high blood pressure and heart problems such as diltiazem, verapamil, guanfacine or digitalis
• Clonidine used for migraines, flushing or high blood pressure
• Medicines which help you sleep such as barbiturates and benzodiazepines
• Pain-killers such as tramadol or 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
100 mg/ml Oral Solution.
Taking Amisulpride 100 mg/ml Oral Solution with food and drink
• Take the solution with a drink that does not contain alcohol
• Do not drink alcohol while you are taking Amisulpride 100 mg/ml Oral Solution. 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 100 mg/ml Oral
Solution 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 100 mg/ml Oral Solution
Amisulpride 100 mg/ml Oral Solution contains small amounts of ethyl alcohol (ethanol), less than 100mg per ml.
Amisulpride 100 mg/ml Oral solution also contains parahydroxybenzoates (propyl hydroxybenzoate E216 and
methyl hydroxybenzoate E218), these may cause allergic reactions (these may be delayed).
3. HOW TO TAKE AMISULPRIDE 100 mg/ml ORAL SOLUTION
Always take Amisulpride 100 mg/ml Oral Solution 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
• Take the solution with a drink that does not contain alcohol
• Use the graduated syringe to measure your medicine. Each 1ml of solution contains 100mg of your medicine
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your
doctor

How much to take
The amount of Amisulpride 100 mg/ml Oral Solution you take will depend on your illness. Follow your doctor’s
instructions carefully.
Adults
• The usual dose is between 50mg (0.5ml) and 800mg (8ml) each day
• Your doctor may start you on a lower dose if necessary
• If necessary your doctor can prescribe up to 1200mg (12ml) each day
• Doses up to 300mg (3ml) each day can be taken as a single dose. Take the dose at the same time each day
• Doses above 300mg (3ml) 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 100 mg/ml Oral Solution should not be given to children under 18 years of age
If you take more Amisulpride 100 mg/ml Oral Solution than you should
If you take more solution 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, feeling drowsy or sleepy which could
lead to a loss of consciousness.
If you forget to take Amisulpride 100 mg/ml Oral Solution
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 100 mg/ml Oral Solution
Keep taking Amisulpride 100 mg/ml Oral Solution until your doctor tells you to stop. Do not stop taking Amisulpride
100 mg/ml Oral Solution just because you feel better. If you stop, your illness may get worse or come back. Unless
your doctor tells you otherwise, Amisulpride 100 mg/ml Oral Solution 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 100 mg/ml Oral Solution 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 100 mg/ml Oral Solution.
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 100 mg/ml Oral Solution can cause side effects, although not everybody gets them.
Stop taking Amisulpride 100 mg/ml Oral Solution 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 lifethreatening 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 100 mg/ml Oral Solution 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)
Not known (frequency cannot be estimated from the available data)
• Feeling confused
• High levels of fat (triglycerides) or cholesterol in the blood
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 100 mg/ml ORAL SOLUTION
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use Amisulpride 100 mg/ml Oral Solution after the expiry date which is stated on the carton and label.
The expiry date refers to the last day of that month.
• Amisulpride 100 mg/ml Oral Solution should be disposed of 2 months after opening.
• 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.
• If your medicine becomes discoloured or show signs of any deterioration, consult your doctor or pharmacist who
will tell you what to do.
6. FURTHER INFORMATION
What Amisulpride 100 mg/ml Oral Solution contains
• Each 1 ml of oral solution contains 100 mg amisulpride.
• The other ingredients are saccharin sodium, sodium gluconate, hydrochloric acid, methyl parahydroxybenzoate
E218, propyl parahydroxybenzoate E216, potassium sorbate, caramel flavour, ethyl alcohol (ethanol) and
purified water.
What Amisulpride 100 mg/ml Oral Solution looks like and contents of the pack
• Amisulpride 100 mg/ml Oral Solution is a clear yellow liquid, with an odour of caramel. It is available in 60 ml
amber glass bottle with a child resistant plastic cap and 5 ml plastic oral syringe graduated in mg.
PL: 15814/1220

POM

Manufactured by Unither Liquid Manufacturing, Colomiers, France.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
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.
Leaflet revision and issue date (Ref.): 13.04.2016.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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