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Active substance(s): SULPIRIDE

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231-30-20126-F LEA SULPIRIDE 200mg TAB TUK

09 February 2016

160 mm

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
• 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:

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


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.

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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
• 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
• 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

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• 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
• 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
• 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
• 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 Sulpiride Tablets 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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231-30-20126-F LEA SULPIRIDE 200mg TAB TUK


09 February 2016

390 mm

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
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

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
• 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
4 Possible side effects
compared with those not receiving
Like all medicines, Sulpiride can cause side
effects, although not everybody gets them.
Blood tests
Stop taking Sulpiride Tablets and see a doctor
Sulpiride Tablets can increase the levels of
or go to a hospital straight away if;
liver enzymes shown up in blood tests. This
Common (may affect up to 1 in 10 people)
can mean that your liver is not working
• You have tremor, stiffness and shuffling
Reporting of side effects
• You have trembling, muscle spasms or
slow movements (extrapyramidal disorders) If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
Rare (may affect up to 1 in 1,000 people)
effects not listed in this leaflet. You can also
• You have very fast or very slow, uneven or report side effects directly via the Yellow Card
forceful heartbeats. You may also have
Scheme at:
breathing problems such as wheezing,
By reporting side effects you can help provide
shortness of breath, tightness in the chest
more information on the safety of this
and chest pain
Not known (frequency cannot be estimated
from the available data)
5 How to store Sulpiride Tablets
• You have a severe allergic reaction
(anaphylactic reaction or anaphylactic
Keep this medicine out of the sight and reach
shock). The signs may include shock such as of children.
difficulty in breathing, dizziness, cold
Store below 30º C. Store in the original
clammy skin, pale skin colour and racing
package and protect from light.
heart beat
Do not use Sulpiride after the expiry date that
• Low blood pressure
is stated on the outer packaging. The expiry
• Alteration of the heart rhythm (called
date refers to the last day of that month.
'Prolongation of QT interval', seen on ECG, Do not throw away any medicines via
electrical activity of the heart)
wastewater or household waste. Ask your
• You have fits
pharmacist how to dispose of medicines no
• You have a high temperature, sweating,
longer required. These measures will help to
stiff muscles, fast heartbeat, fast breathing protect the environment.
and feel confused, drowsy or agitated.
These could be signs of a serious but rare
of the pack and other
6 Contents
side effect called 'neuroleptic malignant
• You have blood clots in the veins especially What Sulpiride tablets contain:
• The active ingredient is 200 mg of sulpiride.
in the legs (symptoms include swelling,
• The other ingredients are lactose,
pain and redness in the leg), which may
pregelatinised maize starch, magnesium
travel through blood vessels to the lungs
stearate, povidone, sodium starch
causing chest pain and difficulty breathing.
If you notice any of these symptoms seek
medical advice immediately
What Sulpiride tablets look like and contents
• You have a life threatening irregular
of the pack:
heartbeat (Torsade de pointes)
• Sulpiride Tablets are white round flat
• You have a cardiac arrest
bevel-edged tablets, with “SPD 200” and a
• You get more infections than usual. This
breakline on one side, and plain on the
could be because of a blood disorder
(agranulocytosis) or a decrease in the
The breakline is only to facilitate breaking
number of white blood cells (neutropenia)
for ease of swallowing and not to divide
• Shortness of breath or difficulty breathing
into equal doses.
• The product is available in pack sizes of 7,
Tell a pharmacist or doctor as soon as
14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112 or
possible if you have any of the following side
120 tablets.
Not all pack sizes may be marketed.
Common (may affect up to 1 in 10 people)
• Feeling restless and not being able to keep Marketing Authorisation Holder and
still (akathisia)
Marketing Authorisation holder and company
Uncommon (may affect up to 1 in 100 people) responsible for manufacture: Teva UK
• Feeling dizzy, light-headed or faint when
Limited, Brampton Road, Hampden Park,
you stand or sit up quickly (due to low
Eastbourne, East Sussex, BN22 9AG, United
blood pressure)
• Abnormal increase in muscle tension and
This leaflet was last revised: January 2016
reduced ability to stretch (hypertonia)
• Involuntary and uncontrollable movements PL 00289/1532
Rare (may affect up to 1 in 1,000 people)
• Rolling of the eyes


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Pharma code: 825

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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.