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Active substance(s): SULPIRIDE

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Sulpiride 200mg Tablets
Sulpiride 400mg Film-Coated Tablets
(Refer to as Sulpiride Tablets in this leaflet)

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Read all of this leaflet carefully before you start to take this medicine.
- Keep this leaflet. You may need to read it again while you are receiving your treatment.
- If you have any further questions, please 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 get 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

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1. What Sulpiride Tablets are and what they are used for
The name of your medicine is Sulpiride Tablets. It contains sulpiride. This belongs to a
group of medicines called benzamides. It works by blocking the effect of a chemical in
the brain.
Sulpiride is used for treating acute and chronic schizophrenia.
2. Before you take Sulpiride Tablets
Do not take Sulpiride Tablets and tell your doctor if:
• you are allergic (hypersensitive) to sulpiride or any other ingredients in these tablets
(listed in Section 6). The signs of an allergic reaction include a rash, itching or
shortness of breath
• you have high blood pressure due to a growth on your adrenal glands
• you have porphyria, a problem with your metabolism that can cause skin blisters, pain
in and around your stomach (abdomen) and brain or nervous system problems
• you are taking Levodopa for Parkinson's Disease
• you have a bone-marrow disorder
• you have breast cancer or a tumour in the pituitary gland (prolactinoma)
Sulpiride Tablets should not be given to you if you are semi-consious or in a coma.
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 this medicine.
Take special care with Sulpiride Tablets
Before you take Sulpiride Tablets, tell your doctor if:
• you have ‘hypomania’. These are mood swings that may show as excitability, anger,
irritability and a lower need for sleep
• you have heart problems. If you or members of your family suffer from heart
problems, your doctor may give you some tests on your heart and blood before giving
you Sulpiride Tablets
• you have epilepsy
• you have Parkinson’s Disease
• you have kidney or liver problems
• you are elderly
• you have dementia
• you have high blood pressure
• you have ever had a stroke
• you or someone else in your family has a history of blood clots, as medicines like
these have been associated with formation of blood clots
• you have severe breathing difficulties
• you have Asthma
• you have myasthenia gravis (extreme weakness) or an enlarged prostate
• you have ever suffered from jaundice (yellowing of the skin and eyes)
• you or a member of your family have had glaucoma
• you have bouts of aggressive behaviour or agitation
• you have low levels of potassium in your body.
Sulpiride may make you sensitive to sunlight, so cover up and use sunscreen when out
in the sun.
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. This includes medicines you buy without a prescription, including herbal
medicines. This is because Sulpiride Tablets can affect the way some other medicines
work. Also, some medicines can affect the way Sulpiride Tablets work.
In particular, tell your doctor if you are taking any of the following:
• pramipexole, ropiniole or levodopa (sometimes this is called L-dopa) used to treat
Parkinson's Disease. You must not take any of these medicines at the same time as
Sulpiride Tablets
• diuretics (water tablets)
• antiarrhythmics, used to steady the heart rhythm, such as amiodarone, sotalol,
disopyramide or quinidine
• sucralfate, used for stomach ulcers, and antacids containing aluminium or magnesium
hydroxide, used for indigestion. It is recommended you take sulpiride tablets at least
two hours before taking sucralfate or these antacids. You should not take sulpiride
tablets with or after taking sucralfate or these antacids
• metoclopramide, used to treat nausea and vomiting, or to empty your stomach
• laxatives
• certain drugs used to treat depression, fluoxetine, lithium and tricyclic
antidepressants, such as dosulepin
• medicines used to treat epilepsy
• medicines used to treat high blood pressure or heart disorders, such as clonidine,
diltiazem, verapamil or digitalis
• medicines to treat infections such as amphotericin, erythromycin or pentamidine
• medicines used to treat mental or emotional problems such as pimozide and
• medicines used to treat diabetes, such as metformin tablets or an insulin injection
• tranquillisers and sleeping tablets such as diazepam, nitrazepam and temazepam
• strong (opioid) pain killers such as morphine, codeine phosphate and dihydrocodeine
• anaesthetics
• mefloquine and quinine, used to prevent or treat malaria
• terfenadine and misolastine, antihistamines, used to treat hay fever and other
• tetracosactide, used to test the function of your adrenal gland
• glucocorticoids (steroids)
• certain drugs used to treat shock, such as adrenaline, ephedrine and dobutamine
• other antipsychotic medicines such as pimozide and thioridazine, used to treat mental
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
before taking Sulpiride Tablets
Taking Sulpiride Tablets with food and drink
Do not drink alcohol while taking Sulpiride Tablets. This is because Sulpiride Tablets
can make you drowsy and alcohol will make you even more drowsy.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, planning to become
pregnant or are breast-feeding.
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
Sulpiride Tablets may make you drowsy or less alert to your surroundings. If this
happens to you, do not drive or use machinery.
Important information about what is in Sulpiride Tablets
This medicine contains lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.

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Sulpiride 200 & 400mg - 30 Tabs
Wockhardt UK
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15th & 22nd April, 2014
 1st PDF sent on - 22ND APRIL 2014

CHANGE CONTROL : Version changes due to change in:
Changes in detail: • Regulatory text amends


keep out of the reach and sight of children
do not store above 25°C
store in the original package in order to protect from light
do not transfer Sulpiride Tablets to another container
do not use after the expiry date which is stated on the label and carton (Exp: month,
the expiry date refers to the last day of that month
do not use Sulpiride Tablets if you notice a change in the appearance or smell of the
medicine. Talk to your pharmacist
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 Sulpiride Tablets contain
• the active ingredient is sulpiride. The tablets come in two strengths of 200mg and 400mg.
• the other ingredients in Sulpiride 200mg Tablets are lactose, microcrystalline
cellulose, povidone K30, sodium starch glycollate and magnesium stearate.
• the other ingredients in Sulpiride 400mg Film-Coated Tablets are lactose,
microcrystalline cellulose, povidone K30, sodium starch glycollate, magnesium
stearate and tablet coating made from titanium dioxide (E171),
hydroxypropylmethylcellulose and polyethylene glycol.
What Sulpiride Tablets look like and contents of the pack
Sulpiride 200mg tablets are white, circular tablets marked S200 on one face and CP on
the reverse.
Sulpiride 400mg Film-Coated Tablets are white, oval, film-coated tablets marked S400
and breakline on one face and CP on the reverse.
Sulpiride tablets are available in blister strip packs of 30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham,
LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free
of charge: 0800 198 5000 (UK Only).
Please be ready to give the following information:
Product name
Reference number
Sulpiride 200mg Tablets
Sulpiride 400mg Film-Coated Tablets
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in January 2014.

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5. How to store Sulpiride Tablets

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Like all medicines, Sulpiride Tablets can cause side effects although not everybody gets
Stop taking this medicine and see a doctor straight away if you have an allergic
reaction to Sulpiride Tablets.
Signs of an allergic reaction may include:
• any kind of skin rash, flaking skin, boils or sore lips and mouth
• sudden wheezing, fluttering or tightness of the chest or collapse.
Stop taking this medicine and see a doctor straight away if you have any of the
• A high temperature, sweating, stiff muscles, fast heartbeat, fast breathing and feel
confused, drowsy or agitated. These could be the signs of a serious but rare side
effect called 'neuroleptic malignant syndrome'
• Very fast or very slow, uneven of forceful heartbeats. You may also have breathing
problems such as wheezing, shortness of breath, tightness in the chest and chest pain.
• 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 get any of the following side effects, see your doctor as soon as possible:
• muscle spasms, jerky movements of your hands or feet, unusual facial movements
• jaundice, which normally shows as yellowing of your skin and whites of the eyes
• inflammation of your liver (hepatitis). The signs of this include feeling sick (nausea),
being sick (vomiting), swelling in your upper abdomen
• feeling more agitated and restless
• having fits
• become delirious or unresponsive with erratic behaviour or movements
• 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 (leucopenia)
• you have a tendency to bleed and/or bruise more easily than usual. This may be due
to a low number of platelets in the blood
• feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood
Tell your doctor if you get any of these side effects:
• feeling sleepy or drowsy
• unable to sleep
• nightmares
• swelling and breast pain (men) and secretion of breast milk in women
• enlarged breasts (in men and women)
• irregular or absent periods
• infertility
• weight gain
• increased or decreased sex drive
• constipation
• problems ejaculating and impotence (in men)

a painful and prolonged erection (in men)
feeling confused
blocked nose and blurred vision
skin rashes, pigmentation of the skin or eyes and sensitivity to sunlight
being unable to stand or sit still
weakness or spasms of the muscles
rigid or stiff muscles
trembling of the hands and
difficulty with walking
• high or low blood pressure
• dry mouth or excessive salivation
• difficulty in swallowing
• difficulty in passing water
• too much glucose in the blood
• too much fat or cholesterol in the
• too little salt in the blood
• hypothermia (feeling very cold)
• cataracts.
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.
Reporting of side effects
If you get any side effects, talk to your doctor pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: By reporting side effects you
can help provide more information on the safety of this medicine.

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4. Possible side effects

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Take this medicine as your doctor or pharmacist has told you.
Look on the label and ask the doctor or pharmacist if you are not sure.
Taking this medicine
• unless instructed differently, take the tablets with a glass of water.
• take this medicine by mouth.
• 400mg twice daily
• the doctor may reduce the dose to 200mg twice daily or increase it to a maximum of
1200mg twice daily
• the usual starting dose in the elderly is one quarter to one half of the adult dose.
The dose should be reduced for patients with kidney problems.
This medicine must not be given to children under the age of 14.
If you take more Sulpiride Tablets than you should
If you take more Sulpiride Tablets than you should, talk to a doctor or go to a hospital
straight away. Take the medicine pack with you so the doctor knows what you have taken.
If you forget to take Sulpiride Tablets
• if you forget a dose, take another as soon as you remember. If it is almost time for
your next dose, do not take the missed dose at all.
• do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Sulpiride Tablets
Keep taking this medicine until your doctor tells you to stop, as it may be necessary to
lower the dose gradually.
Stopping this medication suddenly may lead to withdrawal symptoms such as nausea,
vomiting, runny nose, muscle pains insomnia and anxiety.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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3. How to take Sulpiride Tablets

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.