PACKAGE LEAFLET: INFORMATION FOR THE USER Sulpiride 200mg Tablets Sulpiride 400mg Tablets

(sulpiride)

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.

In this leaflet:

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

2.    Before you take Sulpiride Tablets

3.    How to take Sulpiride Tablets

4.    Possible side effects

5.    How to store Sulpiride Tablets

6.    Further information

1. WHAT SULPIRIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Sulpiride belongs to a group of medicines called antipsychotics. The tablets are used in adults and children over 14 years for the treatment of schizophrenia (mental illness with behaviour problems).

BEFORE YOU TAKE SULPIRIDE TABLETS

Do not take Sulpiride Tablets:

•    If you are allergic (hypersensitive) to sulpiride or any other ingredients in this product (see Section 6 and end of Section 2).Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips,face,throat or tongue

•    If you have been told that you have porphyria (a rare blood disorder)

•    If you have phaeochromocytoma (a tumour on the adrenal gland)

•    If you have breast cancer or cancer in the pituitary gland

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 Sulpiride Tablets.

Take special care with Sulpiride Tablets:

Speak to your doctor before you start to take your tablets if you:

•    have    kidney problems

•    have    high blood pressure

•    have epilepsy or have had fits (seizures)

•    suffer from mania or hypo-mania, as agitation and aggressive behaviour associated with these conditions can be made worse with Sulpride..

•    are elderly (65 years of age or older)

•    have heart problems or a family history of heart problems

•    have ever had a stroke

•    have low levels of potassium in your body (hypokalaemia)

•    have    dementia

•    have    parkinson's disease

•    have low blood levels of Potassium, calcium and magnesium

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those medicines obtained without a prescription, particularly:

•    Drugs used for high blood pressure or heart disorders such as clonidine, diltiazem, verapamil or digitalis.

•    Some medicines to help you sleep or lower your anxiety.

•    Pain killers such as codeine phosphate and dihydrocodeine.

•    Anaesthetics such as enflurane.

•    Sucralfate, used for stomach ulcers, and antacids used for indigestion.

•    Drugs used for Parkinson's disease, such as levodopa.

•    Medicines to control your heartbeat such as amiodarone,sotalol,disopyramide or quinidine

•    Other medicines for schizophrenia such as pimozide,haloperidol,thioridazine

•    Lithium used for some types of mental illness

•    Other medicines used to calm emotional and mental problems

•    Water tablets (diuretics) that can lower the levels of potassium in your blood

•    Some medicines used for constipation (laxatives) that can lower the levels of Potassium in your blood

•    Some medicines used for infections (antibiotics) such as pentamidine,erythromycin or amphotericin B

•    Tetracosactide used to test the function of your adrenal gland

•    Steroids used to lower inflammation such as prednisolone,betamethasone,dexamethasone

•    Some medicines for depression such as imipramine

•    Medicines for indigestion and heartburn

•    Medicines for pain relief. These may also be included in medicines for colds and flu

•    Some medicines used for allergies such as chlorphenaramine,promethazine,ketotifen

•    Ropinarole used for Parkinson's disease

•    Methadone used for pain relief and as a drug substitute

•    Halofantrine used for malaria

•    Anti-convulsants, especially carbamazepine, ethosuximide, oxcarbazepine, phenytoin, primidone and valproate.

•    Tricyclic anti-depressants such as amitriptyline and atomoxetine a drug used to treat attention-deficit hyperactivity disorder (ADHD)

•    Ritonavir and sibutramine

Taking Sulpiride Tablets with food and drink

Do not drink alcohol or take medicines that contain alcohol while being treated with Sulpiride Tablets. This is because alcohol can increase the effects of Sulpiride Tablets.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

Do not breast-feed if you are taking Sulpiride Tablets. This is because small amounts may pass into mother's milk. If you are breast-feeding or planning to breast-feed talk to your doctor or pharmacist before taking any medicine.

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

Driving and using machines

These tablets may cause drowsiness especially at higher dose levels. Do not drive or operate machinery until these symptoms have gone.

Important information about some of the ingredients of Sulpiride Tablets

Lactose:- if you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

•    Take this medicine by mouth

•    Swallow the tablets whole with a glass of water

•    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 usual starting dose is 400mg twice daily. This may be reduced to 200mg twice daily or increased to a maximum of 1200mg twice daily, depending on how you respond to treatment.

Not recommended for children under 14 years of age.

The starting dose may be lower and the rate of increasing the dose slower

If you take more Sulpiride Tablets than you should

If you or someone else swallows several of these tablets all together, contact your doctor or hospital emergency department immediately. Always take any tablets, the leaflet and the box with you as this will allow easier identification of the tablets. The following effects may happen: feeling restless, confused or agitated, having a reduced level of consciousness, trembling, muscle stiffness or spasm, difficulty in movement, movements that you cannot control (for example of the eyes, neck, arms and legs), producing more saliva than usual. In some cases dizziness, lightheadedness, fainting (due to low blood pressure) and coma have happened.

If you forget to take Sulpiride Tablets

If you miss a dose, take it as soon as you remember and carry on as before. If it is almost time for your next dose, skip the forgotten dose and continue as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Sulpiride Tablets

Keep taking Sulpiride Tablets until your doctor tell you to stop. Do not stop taking Sulpiride Tablets just because you feel better. If you stop taking Sulpiride Tablets suddenly, your illness may come back and you may have other unwanted effects such as feeling or being sick, sweating and difficulty sleeping. In some cases you may also feel restless or have movements that you cannot control (for example of the eyes, neck, arms and legs).

Your doctor will gradually lower your dose until you stop your medicine, to prevent these effects happening.

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

POSSIBLE SIDE EFFECTS

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

If you develop a high temperature, muscle stiffness, fainting or excessive drowsiness whilst taking Sulpiride Tablets, stop taking the tablets and contact your doctor immediately.

Side-effects include:

• Allergic reaction (Signs may include: rash,itching,fever,difficulty in breathing or wheezing, chills,swelling)

Drowsiness Weight gain

Increased or decreased sex drive Difficulty in sleeping

Over excitement    _______

•    Agitation

•    Aggression

•    An increase in liver enzymes measured by a blood test by your doctor

•    Fits

i Movements that you can't control, mainly of tongue,mouth,jaws,arms and legs

•    Very fast or very slow, uneven or forceful heartbeats

•    Being unable to stand or sit still

•    Weakness or spasms of the muscles

•    Trembling of the hands and difficulty with walking

•    Temporary stopping of periods

•    Secretion of milk from the breasts in women

•    Enlargement or painful breasts in men and women

•    Blood disorders

•    Low blood pressure

•    Disturbances of the heart rhythm

•    Dry mouth

•    Difficulty in passing water

•    Difficulty in focusing

•    Difficulty in getting or keeping an erection or in ejaculating (impotence)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, speak to your doctor or pharmacist.

HOW TO STORE SULPIRIDE TABLETS

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package and keep containers tightly closed.

Do not use the tablets after the expiry date is stated on the label.

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.

FURTHER INFORMATION

What Sulpiride Tablets contains The active ingredient is sulpiride.

The other ingredients are lactose monohydrate, microcrystalline cellulose, povidone K30, sodium starch glycollate and magnesium stearate. The tablet coating substances for Sulpiride 400mg Tablets are titanium dioxide, hydroxypropylmethylcellulose and polyethylene glycol (see Section 2 'Important information about some of the other ingredients of Sulpiride Tablets').

What Sulpiride Tablets looks like and contents of the pack

Sulpiride Tablets 200mg are white, circular tablets marked S200 on one face and plain on the reverse. Sulpiride Tablets 400mg are white, oval, film coated tablets marked S400 and breakline on one face

and plain on the reverse.

They are available in blister strip packs of 10, 20, 28, 30, 40, 50, 56, 60, 70, 80, 84, 90,100, 112,

500 and 1000 tablets as well as in container packs of 10, 20, 28, 30, 40, 50, 56, 60, 70, 80, 84, 90,100,112, 500 and 1000 tablets (not all pack sizes may be marketed).

MA Holder & Batch Release site:

MEDREICH PLC

9, Royal Parade, Kew Gardens,

Surrey TW9 3QD, England

PL Numbers:

PL 21880/0058-Sulpiride 200mg Tablets PL 21880/0059-Sulpiride 400mg Tablets This leaflet was last approved in November 2011.