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DOLMATIL 200MG TABLETS

Active substance: SULPIRIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

X You have breast cancer or cancer in the
pituitary gland
X You are taking levodopa used for Parkinson’s
disease (see ‘Taking other medicines’ below)
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 Dolmatil
Tablets.

Dolmatil® 200mg Tablets
Dolmatil® 400mg Film-Coated Tablets
sulpiride

Is this leaflet hard to see or read?
Phone 01483 505515 for help

Take special care with Dolmatil Tablets
Check with your doctor or pharmacist before you
take this medicine if:
s You have bouts of aggressive behaviour or are
very agitated
s You have kidney problems
s You have heart problems or a family history
of heart problems. Your doctor may test your
heart function before you take this medicine
s You have ever had a stroke
s If 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
s You have low levels of potassium in your body
(hypokalaemia)
s The person is 65 years of age or older
s You have dementia
s You have Parkinson’s disease
s You have low blood levels of potassium,
calcium and magnesium. Your doctor may do
blood tests to check on these
s You have epilepsy or have had fits (seizures)
s You have a low number of white blood cells
(agranulocytosis). This means you may get
infections more easily than usual
s You have frequent infections such as fever,
severe chills, sore throat or mouth ulcers.
These could be signs of a blood problem called
'leukopenia'
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Dolmatil Tablets.

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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 Dolmatil Tablets are and what they are
used for
2. Before you take Dolmatil Tablets
3. How to take Dolmatil Tablets
4. Possible side effects
5. How to store Dolmatil Tablets
6. Further Information
1. What Dolmatil Tablets are and what they
are used for
Dolmatil Tablets contains a medicine called
sulpiride. This belongs to a group of medicines
called ‘benzamides’. It works by blocking the
effect of a chemical in the brain.
Dolmatil Tablets are used to treat Schizophrenia.
2. Before you take Dolmatil Tablets
Do not take this medicine and tell your
doctor if:
X You are allergic (hypersensitive) to sulpiride or
any of the other ingredients of Dolmatil Tablets
(listed in Section 6 Further Information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
X You have a tumour on the adrenal gland called
‘phaeochromocytoma’
X You have a rare illness called ‘porphyria’ which
affects your metabolism

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 Dolmatil Tablets can affect the way some
other medicines work. Also some medicines
can affect the way Dolmatil works.
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In particular, do not take this medicine and tell
your doctor if you are taking:
• Levodopa used for Parkinson’s disease

this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
Do not breast-feed if you are taking Dolmatil
Tablets. This is because small amounts may pass
into mothers’ milk. If you are breast-feeding or
planning to breast-feed talk to your doctor or
pharmacist before taking any medicine.

Tell your doctor if you are taking any of the
following medicines;
•Medicines to control your heartbeat such as
amiodarone, sotalol, disopyramide or quinidine
•Medicines for high blood pressure or heart
disorders, such as clonidine, diltiazem, verapamil
or digitalis
•Other medicines for schizophrenia such as
pimozide, haloperidol, thioridazine
• Lithium used for some types of mental illness
• Some medicines to help you sleep or lower your
anxiety
• 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
• Sucralfate used for stomach ulcers
•Medicines for pain relief. These may also be
included in medicines for colds and flu
•Some medicines used for allergies
(antihistamines that make you sleepy) such as
chlorphenamine, promethazine, ketotifen
• Ropinorole used for Parkinson’s disease
• Methadone used for pain relief and as a drug
substitute
• Halofantrine used for malaria

The following symptoms may occur in newborn
babies, of mothers that have used Dolmatil
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.
Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breast-feeding.
Driving and using machines
You may feel sleepy after taking this medicine. If
this happens, do not drive or use any tools or
machines.
Important information about some of the
ingredients of Dolmatil Tablets
• Lactose. Dolmatil Tablets contain lactose. If you
have been told by your doctor that you cannot
tolerate some sugars, talk to your doctor before
taking Dolmatil tablets
3. How to take Dolmatil Tablets
Always take Dolmatil Tablets exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets whole with a drink 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

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

How much to take
Adults
• The usual starting dose is 400mg (two 200mg
or one 400mg tablet) to 800mg (four 200mg or
two 400mg tablets) daily depending on your
illness.

Pregnancy and breast-feeding
Talk to your doctor or pharmacist before having
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Stop taking Dolmatil Tablets and see a doctor or go
to a hospital straight away if;
•You have an allergic reaction. The signs may
include: rash, itching, fever, difficulty in breathing
or wheezing, chills, swelling
• You have movements that you cannot control,
mainly of the tongue, mouth, jaw, arms and legs
• 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 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
• 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 in breathing. If you notice any of these
symptoms seek medical advice immediately.
• 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)

•Your doctor may then change your dose
depending on your illness
Patients with Kidney Disease
•The starting dose may be lower and the rate
of increasing the dose slower.
Children under 14 years of age
Dolmatil Tablets are not recommended for
children under 14 years of age.
If you take more Dolmatil Tablets than you should
If you take more Dolmatil Tablets than you
should, tell a doctor or go to a hospital casualty
department straight away. Take the medicine
pack with you. This is so the doctor knows what
you have taken. 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 Dolmatil Tablets
If you forget a dose, take it as soon as you
remember it. However, if it is nearly time for the
next dose, skip the missed dose.

Tell a pharmacist or doctor as soon as possible if
you have any of the following side effects:
• Feeling dizzy, lightheaded or faint when you stand
or sit up quickly (due to low blood pressure)
• Rigid or stiff muscles, trembling or shaking,
difficulty moving
• Feeling restless and not being able to keep still
(akathisia)
• Feeling aggressive, agitated or feeling impulsive

If you stop taking Dolmatil Tablets
Keep taking Dolmatil Tablets until your doctor
tells you to stop. Do not stop taking Dolmatil
Tablets just because you feel better. If you stop
taking Dolmatil 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.
4. Possible side effects
Like all medicines, Dolmatil Tablets can cause side
effects, although not everybody gets them.
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Talk to your doctor or pharmacist if any of the
following side effects gets serious or lasts longer
than a few days:
• Abnormal production of breast milk in men and
women
• Weight gain
• Breast enlargement or painful breasts in men
and women
• Loss of menstrual periods
• Difficulty in getting or keeping an erection or in
ejaculating (impotence)
• Feeling drowsy or sleepy
• Difficulty sleeping (insomnia)
• Skin rashes
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on the other. Supplied in blisters packs of 100
(10X10) tablets or glass bottles of 500 tablets.
• Dolmatil® 400mg Tablets are white film coated
stick shaped tablets with SLP 400 on one side
and a break line on the other. Supplied in
blisters packs of 100 (5X20) tablets.
Not all pack sizes may be marketed.

Blood tests
Dolmatil Tablets can increase the levels of liver
enzymes shown up in blood tests. This can mean
that your liver is not working properly.
Talk to your doctor or pharmacist if any of the side
effects gets serious or lasts longer than a few days, or
if you notice any side effects not listed in this leaflet.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie, 6 Boulevard de
L’Europe, 21800 Quetigny, France

There have been very rare reports of sudden
death with Dolmatil. 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.
5. How to store Dolmatil Tablets
Keep this medicine in a safe place where children
cannot see or reach it.

This leaflet does not contain all the information
about your medicine. If you have any questions
or are not sure about anything, ask your doctor or
pharmacist.
This leaflet was last revised in 10/2012
© Sanofi, 1983 - 2012

Do not use Dolmatil Tablets after the expiry date
which is stated on the label and carton. The
expiry date refers to the last day of that month.
Store below 25°C
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 Dolmatil Tablets contains
• Each 200mg tablet contains 200mg of the active
substance, sulpiride
• The other ingredients in the 200mg tablets are:
starch, lactose, methylcellulose, magnesium
stearate, talc, colloidal hydrated silica
• Each 400mg tablet contains 400mg of the active
substance, sulpiride
• The other ingredients in the 400mg tablets are:
lactose, sodium starch glycollate,
microcrystalline cellulose, hydroxypropylmethylcellulose and magnesium stearate
What Dolmatil Tablets looks like and contents of
the pack
• Dolmatil® 200mg Tablets are plain white round
tablets with D200 on one side and a breakline
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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.

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