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Sulpiride 200mg Tablets

Package leaflet: Information for the user

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:

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1.    What Sulpiride Tablets are and what they are used for

2.    What you need to know before you take Sulpiride Tablets

3.    How to take Sulpiride Tablets

4.    Possible side effects

5.    How to store Sulpiride Tablets

6.    Contents of the pack and other information

OH What Sulpiride Tablets are and what they are used for

Sulpiride belongs to a group of drugs known as antipsychotics.

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

OH What you need to know before you take Sulpiride Tablets 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).

Warnings and precautions

Talk to your doctor before taking 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.

Other medicines and Sulpiride Tablets

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.

Sulpiride with food, drink and alcohol

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

Pregnancy, breast-feeding and fertility

•    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.

Sulpiride Tablets contain lactose

•    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 Tablets

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 recommended 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 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.

•    Use in children and adolescents Children under 14 years old should not take Sulpiride Tablets.

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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 medicine, please ask your doctor or pharmacist.

Possible side effects

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

Stop taking Sulpiride Tablets and see a doctor or go to a hospital straight away if;

Common (may affect up to 1 in 10 people)

•    You have tremor, stiffness and shuffling (parkinsonism)

•    You have trembling, muscle spasms or slow movements (extrapyramidal disorders)

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Rare (may affect up to 1 in 1,000 people)

• You have very fast or very slow, uneven or forceful heartbeats.You may also have breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain

Not known (frequency cannot be estimated from the available data)

•    Your neck becomes twisted to one side

•    Your jaw is tight and stiff

•    Decreased body or muscle movement (hypokinesia)

•    Feeling confused

Talk to your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

Common (May affect up to 1 in 10 people)

•    Abnormal production of breast milk in men and women

•    Weight gain

•    Painful breasts in men and women

•    Feeling drowsy or sleepy

•    Difficulty sleeping (insomnia)

•    Skin rashes

Uncommon (may affect up to 1 in 100 people)

•    Breast enlargement in women

•    Loss of menstrual periods

•    Difficulty in getting or keeping an erection or in ejaculating (impotence) or being unable to have an orgasm

•    Producing more saliva than usual

•    You have movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs (dystonia)

Not known (frequency cannot be estimated from the available data)

•    Breast enlargement in men

•    Uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia)

There have been very rare reports of sudden death with Sulpiride. These are possibly caused by heart problems.

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.

Blood tests

SulpirideTablets can increase the levels of liver enzymes shown up in blood tests.This can mean that your liver is not working properly.

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.

Pharma code: 825

Not known (frequency cannot be estimated

from the available data)

•    You have a severe allergic reaction (anaphylactic reaction or anaphylactic shock). The signs may include shock such as difficulty in breathing, dizziness, cold clammy skin, pale skin colour and racing heart beat

•    Low blood pressure

•    Alteration of the heart rhythm (called 'Prolongation of QT interval', seen on ECG, electrical activity of the heart)

•    You have fits

•    You have a high temperature, sweating, stiff muscles, fast heartbeat, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious but rare side effect called 'neuroleptic malignant syndrome'

•    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 breathing. If you notice any of these symptoms seek medical advice immediately

•    You have a life threatening irregular heartbeat (Torsade de pointes)

•    You have a cardiac arrest

•    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)

•    Shortness of breath or difficulty breathing

How to store Sulpiride Tablets

Keep this medicine out of the sight and reach of children.

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

Do not use Sulpiride after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.

Tell a pharmacist or doctor as soon as possible if you have any of the following side effects:

Common (may affect up to 1 in 10 people)

•    Feeling restless and not being able to keep still (akathisia)

Uncommon (may affect up to 1 in 100 people)

•    Feeling dizzy, light-headed or faint when you stand or sit up quickly (due to low blood pressure)

•    Abnormal increase in muscle tension and reduced ability to stretch (hypertonia)

•    Involuntary and uncontrollable movements (dyskinesia)

Rare (may affect up to 1 in 1,000 people)

•    Rolling of the eyes

©H Contents of the pack and other 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: January 2016 PL 00289/1532

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