PATIENT INFORMATION LEAFLET Amisulpride 50 mg, 100 mg, 200 mg and 400 mg 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 further questions, ask your doctor or your 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 mentioned 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

Amisulpride belongs to a group of medicines called neuroleptics. These are used in the treatment of acute and chronic schizophrenia. This condition causes symptoms such as becoming withdrawn, sensing, seeing or hearing things which do not exist, mistaken beliefs or unfounded suspicions, aggressiveness, paranoid thoughts and depressive mood.

2.    Before you take Amisulpride Tablets Do not take Amisulpride Tablets if you:

-    are allergic (hypersenstitive) to amisulpride or any of the other ingredients of Amisulpride (see section 6 ‘What Amisulpride Tablets Contain’)

-    are breast-feeding (see section “pregnancy and breast-feeding”)

-    have a pituitary gland tumour or breast cancer

-    have a tumour on the adrenal gland (phaeochromocytoma)

-    are taking levodopa, used to treat Parkinson’s disease

-    are under the age of 18

-    are taking any medicines within the “Taking other medicines” section which are listed under “Do not take Amisulpride tablets.”

Take special care with Amisulpride Tablets and Tell your doctor or pharmacist before you start to take this medicine if you:

-    have kidney problems

-    have Parkinson's disease (tremor, stiffness and shuffling)

-    have a history of epileptic seizures (fits)

-    have a heart problem, or a family history of heart disease

-    have a slow heart beat

-    have low potassium levels in your blood (hypokalaemia)

-    have diabetes or you are at a higher risk of having diabetes

-    or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots

-    have abnormally high body temperature

-    have had a stroke before

-    are elderly and suffering from impaired brain function (Dementia)

-    are elderly.

-    have lapp lactose deficiency (you are unable to digest milk or milk product)

-    elderly suffering from renal failure

-    you have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called leukopenia

During your treatment with Amisulpride blood test and ECG monitoring may be performed.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines,

even those not prescribed for you, including herbal medicines. Amisulpride can affect the way some

other medicines work and also some medicines can affect the way Amisulpride works.

Consult your doctor or pharmacist before taking any other medication.

Do not take Amisulpride Tablets if you are taking any of the following:

-    antibiotics such as IV erythromycin, sparfloxacin, halofantrine or pentamidine

-    an antidepressant called sultopride

-    a medicine called thioridazine which can be used as a tranquiliser or to treat conditions such as schizophrenia

-    levodopa (used in Parkinson’s disease)

-    cisapride used to treat heartburn

-    IV vincamine for hypertension

-    methadone used for pain relief.

-    medicines to treat heart problems (arrhythmias), such as bepridil

-    medicines to treat heart problems (arrhythmias), such as quinidine, disopyramide, procainamide, amiodarone or sotalol.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

-    medicines that decrease potassium levels in your blood, e.g. water tablets (diuretics), laxatives, glucocorticoids (to treat severe asthma and other inflammatory disease), amphotericin B (to treat fungal disease), tetracosactides (used to treat anxiety or to help you sleep)

-    medicine to treat malaria (mefloquine)

-    to slow your heart beat or cause your heart beat to slow e.g. beta-blockers, calcium channel blockers (e.g. diltiazem, verapamil)

-    that lower blood pressure such as guanfacine, clonidine and its derivatives;

-    digitalis (to treat congestive heart failure)

-    any other neuroleptics to treat mental disorders such as pimozide, haloperidol, imipramine antidepressants, lithium

-    Central Nervous System depressants (medicines that act on the brain) including narcotics (used for relieving severe pain), analgesics (used for pain relief), sedative H1 antihistamines (to treat allergies and hayfever), barbiturates and benzodiazepines (sleeping tablets) and medicine used to treat anxiety.

-    drugs called dopamine agonists such as ropinirole and bromocriptine

Taking Amisulpride Tablets with Food and Drink

-    Some types of meal may affect how quickly Amisulpride Tablets start to work. If possible, it is best to take Amisulpride tablets before a meal and at about the same time(s) each day.

-    You should not drink alcohol while you are taking Amisulpride Tablets as the effects of alcohol may be increased.

Pregnancy and breast-feeding

- Do not take Amisulpride Tablets if you are pregnant, planning to become pregnant, or are breastfeeding.

-    The following symptoms may occur in newborn babies, of mothers that 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 in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

For women of childbearing age, adequate contraception should be used whilst taking this medicine. Please ask your doctor for advice.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery

-    Amisulpride Tablets may affect your ability to drive a car or use machines. Do not drive or use machines until you know how Amisulpride Tablets affect you.

Please ask your doctor or pharmacist if you are unsure about anything.

Important information about some of the ingredients of Amisulpride Tablets

-    This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Amisulpride Tablets

You must take your tablets exactly as your doctor has told you to. You should ask your doctor or pharmacist if you are not sure.

Always swallow your tablets with plenty of water before a meal and about the same time each day.

•    Adults and children over the age of 18 years old

The usual dose of Amisulpride Tablets is between 50 mg and 800 mg per day. The dose may be increased up to 1200mg per day.

If you are taking 400 mg or less of amisulpride, you should take this once a day.

If you are taking more than 400 mg amisulpride a day you should divide the dose into two - take half in the morning and half in the evening. If you are in any doubt ask your doctor or pharmacist.

•    Elderly

Your doctor should monitor you whilst you are taking Amisulpride Tablets as you are more likely to have low blood pressure or drowsiness.

•    Reduced Kidney Function

Your doctor may decided to give you a lower dose.

•    Children

Amisulpride Tablets must not be used in children under 18 years of age.

If you take more Amisulpride Tablets than you should

If you or someone else swallows too many tablets or you think a child has swallowed any of these tablets, contact your nearest hospital casualty department or a doctor immediately. Always take any remaining tablets and this leaflet with you. Symptoms of an overdose may include coma, low blood pressure, stiffness, restlessness, sleepiness, shaking or slow movement.

If you forget to take Amisulpride Tablets

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for the one you have missed.

If you stop taking Amisulpride Tablets

Do not stop taking Amisulpride Tablets just because you feel better. You should only stop taking your tablets if advised by your doctor. Stopping Amisulpride abruptly, may cause withdrawal effects such as feeling sick, vomiting, sweating, sleeplessness, extreme restlessness, muscle stiffness abnormal movements or your original condition may come back. Always follow your doctor’s instructions carefully.

4. Possible Side Effects

Like all medicines, Amisulpride Tablets can cause side effects, although not everybody gets them.

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

-    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)

-    high temperature combined with faster breathing, sweating, muscle stiffness and reduced consciousness (Neuroleptic Malignant Syndrome)

-    fits (seizures).

This is a very serious but uncommon side effect. You may need urgent medical attention or hospitalisation.

The following side effects have been reported at the approximate frequencies shown:

Very common (affecting more than one person in 10):

-    trembling

-    pronounced muscle stiffness or involuntary muscle contractions (spasms)

-    slowness of movement

-    excess saliva

-    restlessness.

The above very common side effects can occur but will usually be reduced if your dose of Amisulpride Tablets is lowered by your doctor or if your doctor prescribes you an additional medicine.

Common (affecting fewer than one person in 10 but more than one person in 100):

-    difficulty sleeping (insomnia)

-    anxiety

-    involuntary muscle contractions (spasms)

-    agitation

-    difficulty in reaching orgasm

-    constipation

-    feeling and/or being sick

-    dry mouth

-    low blood pressure

-    weight gain.

The following side effects can occur but are reversible after you stop taking this medicine:

-    impotence (inability to get or maintain erection)

-    breast pain and secretion of breast milk

-    absence of menstrual periods

breast enlargement in men.

Uncommon (affecting fewer than one person in 100 but more than one person in 1,000):

-    high blood sugar levels (hyperglycemia)

-    slow heart beat

-    changes in the level of liver enzymes

-    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)

-    involuntary movement of the face and or tongue.

The following have also been reported at an unknown frequency:

•    heart problems including abnormal heart rhythm and sudden unexplained death have also been reported

•    high temperature combined with faster breathing, sweating, muscle stiffness and reduced consciousness (Neuroleptic Malignant Syndrome)

•    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

•    swelling of face or throat

•    itchy skin rash

•    in elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.

•    decrease in the number of white blood cells.

•    withdrawal syndrome of infants

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.

5. How to Store Amisulpride Tablets

-    Keep out of the reach and sight of children.

-    This product does not require any special storage conditions.

-    Do not take this medicine after the expiry date stated on the outer carton. The expiry date refers to the last day of that month.

-    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 active substance is amisulpride. Each tablet contains either 50mg, 100mg, 200mg or 400mg of amisulpride.

-    Amisulpride 50mg, 100mg and 200mg Tablets also contain maize starch, lactose monohydrate, methylcellulose, Colloidal silica anhydrous, magnesium stearate.

-    Amisulpride 400mg Tablets also contain sodium starch glycolate, lactose monohydrate, methylcellulose, microcrystalline cellulose (E460), magnesium stearate (E572). The tablet coating contains, basic butylated methacrylate polymers (Eudragit E100), titanium dioxide (E171), talc, magnesium stearate, and macrogol 6000.

What Amisulpride Tablets look like and contents of the pack

-    Amisulpride 50mg Tablets are white to off-white, round tablets with a break line on one side and A1 on the reverse.

-    Amisulpride 100mg Tablets are white to off-white, round tablets with a break line on one side and A2 on the reverse.

-    Amisulpride 200mg Tablets are white to off-white, round tablets with a break line on one side and A3 on the reverse.

-    Amisulpride 400mg Tablets are white to off-white film-coated, capsule-shaped tablets with a break line on one side, plain on the other.

-    Amisulpride Tablets are packed in blisters and are available in pack sizes of 60 tablets.

Marketing Authorisation and Holder and Manufacturer

The marketing authorisation holder is Ivax Pharmaceuticals UK Limited Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX Company responsible for manufacture is TEVA UK Limited, Eastbourne, BN22 9AG

This leaflet was last revised in September 2013

PL 00530/0727-30