SULPIRIDE 200 mg TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 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.

IN THIS LEAFLET:

1.    What Sulpiride is and what it is used for

2.    Before you take Sulpiride

3.    How to take Sulpiride

4.    Possible side effects

5.    How to store Sulpiride

6. Further information

Ol WHAT SULPIRIDE IS AND WHAT IT IS USED FOR

Sulpiride belongs to a group of drugs known as antipsychotics.

Sulpiride Tablets are used to treat a mental disorder called schizophrenia.

BEFORE YOU TAKE SULPIRIDE

DO NOT take Sulpiride if you:

• have ever had a growth near your adrenal gland (phaeochromocytoma)

• have acute porphyria (a rare metabolic disorder)

• have prolactin-dependant tumours (e.g. pituitary gland prolactinomas and breast cancer)

• have ever had a bad reaction to Sulpiride or to any of the other ingredients listed Section 6 "What Sulpiride Tablets contain"

• are taking levodopa (used to treat Parkinson's disease).

Take special care with Sulpiride

Talk to your doctor before you start to take

this medicine if you:

• have problems with your kidneys • suffer from epilepsy • have hypomania (persistent elevated or irritable mood), or are aggressive, agitated or impulsive

• have Parkinson's disease • (for women) have a growth in your breast or a history of this

• are already receiving treatment for schizophrenia, are taking pain killers or tranquillisers (drugs to calm you down)

• are pregnant, may become pregnant or are breast-feeding

• have an imbalance of salts in the blood, in particular potassium (shown by blood tests) • have heart problems or have a family history of heart problems • have previously had a stroke, transient ischaemic attack (TIA) or heart attack, or have a family history of strokes • have a slow heart beat (less than 55 beats per minute)

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

• are a child under the age of 14 years • are elderly, as you may be more likely to get certain side effects (see section 4, Possible Side Effects).

If you need a blood test or a test to check the levels of glucose or cholesterol in your body, please tell the doctor that you are taking Sulpiride Tablets.Your tablets may alter the results of the tests.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Sulpiride Tablets can affect the way some other medicines work. Also some medicines can affect the way Sulpiride Tablets work.

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

• levodopa, used to treat Parkinson's disease.

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

• diuretics (water tablets) such as furosemide • medicines to control your heartbeat such as amiodarone, disopyramide, or quinidine • medicines known as beta-blockers, used to treat high blood pressure, angina or

abnormal heart rhythms such as atenolol, bisoprolol, sotalol

•    medicines known as calcium channel blockers, used to treat high blood pressure or angina, such as diltiazem, verapamil

•    digitalis or digoxin, used to treat heart failure or abnormal heart rhythms

•    clonidine, used to treat high blood pressure, migraine or menopausal flushing

•    other medicines used to treat schizophrenia such as pimozide, haloperidol, thioridazine

•    other neuroleptic medicines similar to sulpiride, such as promazine, amisulpride

•    some medicines used to treat anxiety or help you sleep, examples include barbiturates such as phenobarbital, benzodiazepines such as diazepam, nitrazepam or temazepam, and other anxiolytics or hypnotics

•    some medicines used intravenously to treat infections (antibiotics) such as erythromycin, or amphotericin B

•    pentamidine, used to treat and prevent pneumonia

•    lithium, used to treat certain types of mental illness

•    certain antidepressants, such as imipramine, fluoxetine or paroxetine

•    halofantrine, mefloquine and quinine, used to treat malaria

•    tetracosactide, used to test the function of your adrenal gland

•    medicines used to treat indigestion and heartburn

•    sucralfate, used to treat ulcers in the stomach or intestines

•    cisapride, or other stimulant laxatives used to treat constipation such as bisacodyl or senna

•    ropinirole, used to treat Parkinson's disease

•    baclofen, used as a muscle relaxant

•    thalidomide, used to treat bone marrow cancer

•    painkillers (analgesics) such as paracetamol or aspirin; these may also be contained in medicines for colds and flu

•    strong (opioid) painkillers such as morphine, codeine phosphate or tramadol

•    methadone, used for pain relief, or as a drug substitute

•    some antihistamines that make you sleepy, used to treat allergic reactions, such as chlorphenamine, promethazine or ketotifen

•    corticosteroids used to treat inflammation such as hydrocortisone, prednisolone, betamethasone, dexamethasone.

Taking Sulpiride with food and drink

•    DO NOT drink alcohol while you are taking Sulpiride Tablets, as alcohol increases the sedative effect of sulpiride.

Pregnancy and breast-feeding

•    Sulpiride is not recommended if you are pregnant or planning to become pregnant. Ask your doctor for advice before taking any medicine.

•    The following symptoms may occur in newborn babies of mothers that have used Sulpiride 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.

•    Sulpiride passes in to breast milk, therefore breastfeeding is not recommended whilst taking Sulpiride Tablets.

Driving and using machines

•    Sulpiride may cause drowsiness or blurred or distorted vision. If you are affected, DO NOT drive or operate machinery.

Important information about some of the ingredients of Sulpiride

•    Patients who are intolerant to lactose should note that SulpirideTablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

^ HOW TO TAKE SULPIRIDE

Always take Sulpiride exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed preferably with a drink of water.

The usual dose is:

•    Adults including the Elderly

The most common starting dose is between 400 mg and 800 mg a day (usually one or two tablets twice a day).Take the tablets in the morning and early evening.

Your doctor may adjust your dose depending on your response to the

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treatment, and may increase your dose to up to 1200 mg (6 tablets) twice a day, or reduce it to 200 mg (one tablet) twice a day.

•    Patients with kidney problems

If you have kidney problems, your doctor may give you a lower dose.

•    Children under 14 years of age

Children under 14 years old should not take Sulpiride Tablets.

If you take more Sulpiride than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

An overdose is likely to cause restlessness, agitation, confusion, shaking, low blood pressure, drowsiness or coma.

Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Sulpiride

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. If it is almost time to take the next dose, wait until then and then carry on as before.

If you stop taking Sulpiride

Do not stop taking Sulpiride without talking to your doctor first even if you feel better. If you stop taking your tablets abruptly you may experience withdrawal symptoms such as feeling or being sick, sweating or have problems sleeping. You may have hallucinations, delusions or suffer a change in behaviour. You may also experience restlessness or involuntary muscle movements which may affect your lips, tongue, eyelids, arms, legs or body trunk. When you stop taking Sulpiride, your doctor will reduce the dose gradually to avoid the possibility of withdrawal symptoms.

If you have any further questions on the use of this product, please ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Sulpiride 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, causing swelling of the lips, face or neck leading to severe difficulty in breathing, or severe skin rash or hives.

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

Contact your doctor immediately if you suffer from:

•    neuroleptic malignant syndrome, a reaction to certain drugs for psychiatric conditions causing fever, sweating, muscle stiffness, decreased muscle control, varying blood pressure, and palpitations. Sometimes agitation and confusion or impairment of consciousness may also be accompanying symptoms.Tell your doctor immediately if you suffer from any of the above symptoms

•    symptoms include swelling, pain and redness in the leg; this may be due to blood clots in the veins especially in the legs, 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.

Tell your doctor if you suffer from any of the following for more than a few days:

•    uncontrolled movements especially in your limbs and face and you may feel agitated, have a feeling of being unable to sit still, being aggressive and excited (especially if you are on a high dose)

•    dry mouth, blurred or distorted vision, problems passing urine or feeling the need to go to the toilet more often, drowsiness and reduced energy, difficulty sleeping and weight gain.

The following side effects have also been reported:

•    high fever, sore throat, skin rash, persistent or recurrent infections and sores on your body, mouth or genital areas. These may be due to a reduction in the number of white blood cells in your blood (leucopenia)

•    increased levels of the hormone prolactin (hyperprolactinaemia, shown by blood tests), which may cause abnormal discharge of milk from nipples

(galactorrhoea), stopping of menstrual periods in women (amenorrhoea), enlargement of the breasts in men (gynaecomastia), changes in sex drive, breast enlargement, breast pain, orgasmic disorder and inability to get or maintain an erection

•    drowsiness, movement disorders which may cause muscle spasms, restlessness, and rhythmic, involuntary movements (known as extrapyramidal symptoms), dry mouth, difficulty sleeping, fits, symptoms include tremor (shaking), difficultly stretching muscles, drooling, inability to open the mouth normally

•    rotating of the eyeballs (oculogyric crisis), paralysis of muscles in the eye, so you cannot re-focus on different distances (paralysis of accommodation)

•    disturbance of cardiac rhythm such as uneven heartbeats (arrhythmias), fast heartbeats (tachycardia), uncoordinated, very fast heartbeats (ventricular fibrillation), or heart attack

•    dizziness on standing

•    an increased presence of certain enzymes in your body

•    a flat, red area of skin that is covered with small adjoining bumps (maculopapular rash)

•    neck spasm

•    inability to urinate, inability to control urinating, or painful urinating

•    weight gain, weariness or weakness.

Heart attack, palpitations and shortness of breath, and sudden death have been reported with neuroleptic drugs. It is not known if Sulpiride may cause these.

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.

Your doctor may need to perform blood tests to confirm if you have some of these conditions.

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 theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

[4 HOW TO STORE SULPIRIDE

Keep out of the reach and sight of children.

Store below 30° C. Store in the original package and protect from light.

Do not use Sulpiride after the expiry date that s stated on the outer packaging.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 onger required.These measures will help to protect the environment.

^ FURTHER INFORMATION

What Sulpiride tablets contain:

•    The active ingredient is 200 mg of sulpiride.

•    The other ingredients are lactose, pregelatinised maize starch, magnesium stearate, povidone, sodium starch glycolate.

What Sulpiride tablets look like and contents of the pack:

•    Sulpiride Tablets are white round flat bevel-edged tablets, with "SPD 200" and a breakline on one side, and plain on the reverse.

The breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

•    The product is available in pack sizes of 7,

14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112 or 120 tablets.

Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture:Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom.

This leaflet was last revised: May 2015

PL 00289/1532

20126-E

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