Skip to Content

DOLMATIL 200MG TABLETS

Active substance(s): SULPIRIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Accord Spécification

Accord CQL
Site de Dijon

Polices / Fonts : Ocean Sans/ZapfDin.
Texte corps mini / Text size mini : 10 pt

Delpharm

Code AC / Item : 700947
Description AC : Notice Dolmatil 200/400 mg
Destination :
Grande Bretagne
Date / Version : 15/04/16 V1
Dimension :
210x148 mm
Type :
Roul. double

Code actuel / Current code : 700668
Couleur (s) / Color(s) : 1

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.

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

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

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'
▲ You have high blood pressure
▲ You have painful eyes with blurred vision
(glaucoma)
▲ You have a type of bowel obstruction (ileus)
▲ You have difficulty passing water (urine)
▲ You have an enlarged prostate
▲ You have a digestive problem called
congential digestive stenosis
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Dolmatil Tablets.

*700947*

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’
700947

Taking other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken

SENS DE DEROULEMENT
RECTO
(Intérieur bobine)

1

Accord Spécification

Accord CQL
Site de Dijon

Polices / Fonts : Ocean Sans/ZapfDin.
Texte corps mini / Text size mini : 10 pt

Delpharm

Code AC / Item : 700947
Description AC : Notice Dolmatil 200/400 mg
Destination :
Grande Bretagne
Date / Version : 15/04/16 V1
Dimension :
210x148 mm
Type :
Roul. double

Code actuel / Current code : 700668
Couleur (s) / Color(s) : 1

Bleu PMS Reflex Blue U
Plan N° : N 84

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

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.
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
heartdisorders, 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
(anti-histamines 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 beco-me 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.
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
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
recommended for children under
14 years of age.
700947

2

Accord Spécification

Accord CQL
Site de Dijon

Polices / Fonts : Ocean Sans/ZapfDin.
Texte corps mini / Text size mini : 10 pt

Delpharm

Code AC / Item : 700947
Description AC : Notice Dolmatil 200/400 mg
Destination :
Grande Bretagne
Date / Version : 15/04/16 V1
Dimension :
210x148 mm
Type :
Roul. double

Code actuel / Current code : 700668
Couleur (s) / Color(s) : 1

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.
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
700947

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
• High blood pressure
3

Accord Spécification

Accord CQL
Site de Dijon

Polices / Fonts : Ocean Sans/ZapfDin.
Texte corps mini / Text size mini : 10 pt

Delpharm

Code AC / Item : 700947
Description AC : Notice Dolmatil 200/400 mg
Destination :
Grande Bretagne
Date / Version : 15/04/16 V1
Dimension :
210x148 mm
Type :
Roul. double

Code actuel / Current code : 700668
Couleur (s) / Color(s) : 1

Bleu PMS Reflex Blue U
Plan N° : N 84

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

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.
5. How to store Dolmatil Tablets

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, hydroxypropylmethyl-cellulose 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
Delpharm Dijon, 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.
This leaflet was last revised in 04/2016
© Sanofi, 1983 - 2016

Keep this medicine in a safe place where
children cannot see or reach it.
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
700947

4

Expand view ⇕

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.

Hide