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DOLMATIL 200MG TABLETS

Active substance: SULPIRIDE

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Site de Quetigny

Polices / Fonts : Ocean Sans/ZapfDin.
Texte corps mini / Text size mini : 10 pt
Code actuel / Current code : 485977
Couleur (s) / Color(s) : 2

Noir + Bleu PMS Reflex Blue U
Plan N° : N 84

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

PACKAGE LEAFLET:
INFORMATION FOR THE USER

X You have a rare illness called ‘porphyria’
which affects your metabolism
X You have breast cancer or cancer in the
pituitary gland
X You are taking levodopa or ropinirole 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.
Take special care with Dolmatil Tablets
Check with your doctor or pharmacist
before you take this medicine if:
▲ You have bouts of aggressive behaviour
or are very agitated
▲ You have kidney problems
▲ You have heart problems or a family history of heart problems. Your doctor may
test your heart function before you take
this medicine
▲ You have ever had a stroke
▲ 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
▲ You have low levels of potassium in your
body (hypokalaemia)
▲ The person is 65 years of age or older
▲ You have dementia
▲ You have Parkinson’s disease
▲ You have low blood levels of potassium,
calcium and magnesium. Your doctor
may do blood tests to check on these
▲ You have epilepsy or have had fits (seizures)
▲ You have a low number of white blood
cells (agranulocytosis). This means you
may get infections more easily than usual
▲ 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.

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

Is this leaflet hard to see or
read?
Phone 0845 372 7101 for
help

*516594*

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’

sanofi aventis

Code AC / Item : 516594
Description AC : Notice Dolmatil 200/400 mg
Destination :
Grande Bretagne
Date / Version : 17/03/15 V6
Dimension :
210x148 mm
Type :
Roul. double

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
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affect the way Dolmatil works.
516594

SENS DE DEROULEMENT
RECTO
(Intérieur bobine)

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Accord Spécification

Accord CQL

Site de Quetigny

Polices / Fonts : Ocean Sans/ZapfDin.
Texte corps mini / Text size mini : 10 pt
Code actuel / Current code : 485977
Couleur (s) / Color(s) : 2

Noir + Bleu PMS Reflex Blue U
Plan N° : N 84

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

In particular, do not take this medicine and
tell your doctor if you are taking:
• Levodopa used for Parkinson’s disease
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
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.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before having
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 breastfeeding 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
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

516594

sanofi aventis

Code AC / Item : 516594
Description AC : Notice Dolmatil 200/400 mg
Destination :
Grande Bretagne
Date / Version : 17/03/15 V6
Dimension :
210x148 mm
Type :
Roul. double

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
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.
•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 recomTurn
mended for children under
Over
14 years of age.
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Accord CQL

Site de Quetigny

Polices / Fonts : Ocean Sans/ZapfDin.
Texte corps mini / Text size mini : 10 pt
Code actuel / Current code : 485977
Couleur (s) / Color(s) : 2

Noir + Bleu PMS Reflex Blue U
Plan N° : N 84

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

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.
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.

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
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
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

4. Possible side effects
Like all medicines, Dolmatil Tablets can cause
side effects, although not everybody gets them.
Stop taking Dolmatil 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)
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

Turn
Over

516594

sanofi aventis

Code AC / Item : 516594
Description AC : Notice Dolmatil 200/400 mg
Destination :
Grande Bretagne
Date / Version : 17/03/15 V6
Dimension :
210x148 mm
Type :
Roul. double

3

Accord Spécification

Accord CQL

Site de Quetigny

Polices / Fonts : Ocean Sans/ZapfDin.
Texte corps mini / Text size mini : 10 pt
Code actuel / Current code : 485977
Couleur (s) / Color(s) : 2

Noir + Bleu PMS Reflex Blue U
Plan N° : N 84

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

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.

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 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.
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.
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:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.

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 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.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie, 6 Boulevard de
L’Europe, 21800 Quetigny, France
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.

5. How to store Dolmatil Tablets
Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Dolmatil Tablets after the expiry

516594

sanofi aventis

Code AC / Item : 516594
Description AC : Notice Dolmatil 200/400 mg
Destination :
Grande Bretagne
Date / Version : 17/03/15 V6
Dimension :
210x148 mm
Type :
Roul. double

This leaflet was last revised in 03/2015
© Sanofi, 1983 - 2015

4

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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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