Amisulpride 50mg, 100mg, 200mg and 400mg Tablets

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.
• Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.

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

Do not take amisulpride and tell your doctor if:

• You are allergic (hypersensitive) to amisulpride or any of the other ingredients of amisulpride (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 below)
• You have breast cancer or something called 'a prolactin dependent tumour'
• You have a tumour on your adrenal gland (called phaeochromocytoma)
• The person taking this medicine is under 15 years old. This medicine is not suitable for children under 15 years old.

Do not take 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 and check with your doctor before taking amisulpride if:

• You have kidney problems
• You have diabetes. Your diabetes may need careful monitoring
• You have Parkinson's disease
• You have ever had fits (epileptic seizures)
• You have an unusual heart rate (rhythm)
• You are elderly. This is because elderly people would be more likely to get low blood pressure or feel sleepy
• You have low potassium levels in your blood
• You are taking any drugs which may lower potassium levels (such as thiazide, diuretics, bendroflumethiazide, hydrochlorothiazide).
• You have been told by your doctor that you might have a stroke.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking amisulpride.

Taking amisulpride with 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.

Do not take this medicine, and tell your doctor, if you are taking:

• Medicines used to control your heart beat such as quinidine, disopyramide, procainamide, amiodarone and sotalol
• Medicines which act on the brain such as pimozide, haloperidol, imipramine, thioridazine, sultopride and lithium
• Medicines for severe pain such as morphine, pethidine (opioids) and methadone
• Levodopa, a medicine to treat Parkinson's disease
• Calcium-channel blockers (used to treat high blood pressure and angina) such as verapamil, diltiazem or bepridil
• Antibiotics such as erythromycin (given by injection) or sparfloxacin
• Vincamine, a medicine that helps the blood flow to the brain
• Cisapride, a medicine used to treat heartburn
• Pentamidine, a medicine used to treat pneumonia
• Halofantrine, a medicine used to treat malaria

Tell your doctor if you are taking any of the following:

• Medicines which may lower potassium levels. This includes water tablets such as bendrofluazide or hydrochlorothiazide
• Medicines for high blood pressure and migraine such as clonidine, diltiazem and verapamil, guanfacine and digitalis
• 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

Taking amisulpride 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 amisulpride can change the way the alcohol affects you.

Pregnancy and breast-feeding

Do not use this medicine if:

• You are pregnant, might become pregnant, or think you may be pregnant.
• You are breast-feeding or planning to breast-feed.

Driving and using machines

This medicine may cause drowsiness. If this happens do not drive or use machines.

Important information about some of the ingredients of amisulpride

• Lactose: This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before having this medicine.

Taking this medicine

• Swallow the tablets whole with a drink of water.
• Take before a meal

How much to take

Adults and children over 15 years old

• The usual dose is between 50mg and 800mg each day
• Your doctor may start you on a lower dose if necessary
• If necessary your doctor can prescribe up to 1200mg each day
• Doses up to 300mg each day can be taken as a single dose. Take the dose at the same time each day
• Doses above 300mg should be taken half in the morning and half in the evening
• If you have kidney problems your doctor may prescribe you a lower dose
• Elderly people may be prescribed a lower dose. This is because amisulpride may make you feel sleepy or lower your blood pressure which could make you feel dizzy, light headed or faint.

Children

Do not give this medicine to children under 15 years old.

If you take more amisulpride 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, feeling drowsy or sleepy which could lead to a loss of consciousness.

If you forget to take amisulpride

If you forget to take a dose at the right time, take it as soon as you remember, then go on as before. However, do not take a double dose to make up for a forgotten tablet.

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.

Stop taking amisulpride and see a doctor or go to a hospital straight away if:

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).
  This may mean you are having an allergic reaction to amisulpride tablets
• You have an unusual heart rate, very fast heart rate or chest pain. These could be signs of a heart attack or life-threatening heart disorder
• 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 side effect called 'neuroleptic malignant syndrome'
• You have a fit (seizure). This side effect happens in less than 1 in 100 people who take this medicine.

Tell your doctor as soon as possible if you have any of the following side effects:

• Trembling, muscle stiffness or spasm, slow movement, producing more saliva than usual or feeling restless. (These symptoms can be reduced if your doctor lowers your dose of amisulpride or prescribes an additional medicine). This side effect affects more than 1 in 10 people taking amisulpride.
• Movements that you cannot control, mainly of your arms and legs (this will usually be reduced if your dose of amisulpride is lowered by your doctor or if your doctor prescribes you an additional medicine). This side effect affects less than 1 in 10 people taking amisulpride.
• Movements that you cannot control, mainly of your face or tongue. This side effect affects less than 1 in 100 people taking amisulpride.

Other side effects include:

Uncommon side effects (affects less than 1 in every 100 people)

• Feeling nervous, shaky or sweaty. These may be signs of low blood sugar levels (hypoglycaemia).
• Slowing of the heart beat

Common side effects (affects less than 1 in every 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)

What Amisulpride 50mg, 100mg, 200mg or 400mg Tablets contain

Each tablet contains 50mg, 100mg, 200mg or 400mg of amisulpride as the active substance.

The other ingredients are, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hypromellose and magnesium stearate. The 400mg tablet also contains polyoxyl 40 stearate and titanium dioxide (E171).

What amisulpride looks like and contents of the pack

Amisulpride 50mg Tablets are white to off-white, round, flat-faced tablets engraved AMI 50 on one side. They are supplied in blister packs of 60 tablets.

Amisulpride 100mg Tablets are white to off-white, round, flat-faced tablets engraved AMI 100 on one side and a breakline on the other side. They are supplied in blister packs of 60 tablets.

Amisulpride 200mg Tablets are white to off-white, round, flat-faced tablets engraved AMI 200 on one side and a breakline on the other side. They are supplied in blister packs of 60 tablets.

Amisulpride 400mg Tablets are white, film-coated, oblong tablets engraved AMI 400 on one side. They are supplied in blister packs of 60 tablets.

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