Package leaet:
Information for the user
Domperidone
10mg Tablets
domperidone maleate
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 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 Domperidone Tablets are and what
they are used for
2. What you need to know before you take
Domperidone Tablets
3. How to take Domperidone Tablets
4. Possible side effects
5. How to store Domperidone Tablets
6. Contents of the pack and other
information
1. WHAT DOMPERIDONE TABLETS
ARE AND WHAT THEY ARE USED
FOR
The name of your medicine is Domperidone
10mg Tablets (called Domperidone in this
leaflet). Domperidone Tablets contain
domperidone as the active ingredient, which
belongs to a group of medicines called
‛dopamine antagonists’.
This medicine is used to treat nausea
(feeling sick) and vomiting (being sick) in
adults and adolescents (12 years of age and
older and weighing 35 kg or more).
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE DOMPERIDONE
TABLETS
Do not take Domperidone Tablets if:
• You are allergic (hypersensitive) to
domperidone or any of the other
ingredients of Domperidone 10mg
tablets (listed in section 6).
Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or
tongue.
• You have black, tarry bowel motions
(stools) or notice blood in your bowel
motions. This could be a sign of bleeding
in the stomach or intestines
• You have a blockage or tear in your
intestines
• You have a tumour of the pituitary gland
(prolactinoma).
• You have a moderate or severe liver
disease
• Your ECG (electrocardiogram) shows
a heart problem called “prolonged QT
corrected interval”
• You have or had a problem where your
heart cannot pump the blood round
your body as well as it should (condition
called heart failure).
• You have a problem that gives you a low
level of potassium or magnesium, or a
high level of potassium in your blood.
• You are taking certain medicines (see
“Other medicines and Domperidone
tablets”).
Do not take Domperidone tablets if any
of the above applies to you. If you are not
sure, talk to your doctor or pharmacist
before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Domperidone 10mg Tablets if:
• You suffer from liver problems (liver
function impairment or failure) (see “Do
not take Domperidone Tablets if”)
• You suffer from kidney problems (kidney
function impairment or failure). It is
advisable to ask your doctor for advice
in case of prolonged treatment as you
may need to take a lower dose or take
this medicine less often, and your doctor
may want to examine you regularly.
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Domperidone. Do this even if
they have applied in the past.
Domperidone may be associated with an
increased risk of heart rhythm disorder and
cardiac arrest.
This risk may be more likely in those over
60 years old or taking doses higher than
30mg per day.
The risk also increases when domperidone
is given together with some drugs.
Tell your doctor or pharmacist if you are
taking drugs to treat infection (fungal
infections or bacterial infection) and/or
if you have heart problems or AIDS/HIV
(see “Other medicines and Domperidone
tablets”).
Domperidone should be used at the lowest
effective dose. While taking domperidone,
contact your doctor if you experience heart
rhythm disorders such as palpitations,
trouble breathing, loss of consciousness.
Treatment with domperidone should be
stopped.
Adolescents weighing less than 35 kg
and children
Domperidone should not be given to
adolescents 12 years of age and older
weighing less than 35 kg, or in any children
less than 12 years of age, as it is not
effective in these age groups.
Other medicines and Domperidone
tablets
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines you can
buy without a prescription, including herbal
medicines. This is because Domperidone
can affect the way some other medicines
work. Also, some medicines can affect the
way Domperidone works.
Do not take Domperidone tablet if you are
taking medicine to treat:
• Fungal infections such as azole
antifungals, specifically oral
ketoconazole, fluconazole or
voriconazole
• Bacterial infections, specifically
erythromycin, clarithromycin,
telithromycin, moxifloxacin, pentamidine
(these are antibiotics)
• Heart problems or high blood pressure
(e.g., amiodarone, dronedarone,
quinidine, disopyramide, dofetilide,
sotalol, diltiazem, verapamil)
• Psychoses (e.g., haloperidol, pimozide,
sertindole)
• Depression (e.g., citalopram,
escitalopram)
• Gastro-intestinal disorders (e.g.,
cisapride, dolasetron, prucalopride)
• Allergy (e.g., mequitazine, mizolastine)
• Malaria (in particular halofantrine)
• AIDS/HIV (protease inhibitors)
• Cancer (e.g., toremifene, vandetanib,
vincamine)
Tell your doctor or pharmacist if you
are taking drugs to treat infection, heart
problems, AIDS/HIV or Parkinson’s disease.
Domperidone and apomorphine
Before you use Domperidone tablet and
apomorphine, your doctor will ensure that
you tolerate both medicines when used
simultaneously. Ask your doctor or specialist
for a personalised advice. Please refer to
apomorphine leaflet.
It is important to ask your doctor or
pharmacist if Domperidone tablet is safe
for you when you are taking any other
medicines, including medicines obtained
without prescription.
Taking Domperidone Tablets with food
and drink
It is recommended to take Domperidone
before meals, as when taken after meals
the absorption of the medicine is slightly
delayed.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before
taking Domperidone tablets if:
• You are pregnant, might become
pregnant or think you may be pregnant
• You are breast-feeding. It is best not
to take Domperidone tablets if you
are breast-feeding. Small amounts of
Domperidone have been detected in
breast milk.
Domperidone may cause unwanted side
effects affecting the heart in a breast-
fed baby. Domperidone should be used
during breast feeding only if your physician
considers this clearly necessary. Ask
your doctor for advice before taking this
medicine.
Driving and using machines
Domperidone can affect your ability to
drive or use machinery as it may make
you sleepy. Do not drive while taking this
medicine until you know how it affects you.
Important information about some of the
ingredients of Domperidone Tablets
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.
N08506XX
Black
Version: 11
Date & Time: 29.01.2024 & 10.30 AM
Submission Code: N08506
Information on sodium
content
This medicine contains
less than 1mmol sodium
(23mg) per tablet, that is
to say essentially ‘sodium
free’
3. HOW TO TAKE
DOMPERIDONE
TABLETS
Always take Domperidone
Tablets exactly as your
doctor has told you. You
should check with your
doctor or pharmacist if you
are not sure.
Duration of treatment:
Your doctor will decide how long you will
need to take this medicine.
Symptoms usually resolve with 3-4 days
of taking this medicine. Do not take
Domperidone tablets for longer than 7 days
without consulting your doctor.
Taking this medicine
• Swallow the tablets whole with a drink of
water.
• Take the tablets 15 to 30 minutes before
a meal.
• Do not crush or chew them
The usual dose is:
Adults and adolescents 12 years of
age and older with a body weight of
35 kg or more
• The usual dose is one tablet taken up
to three times per day, if possible before
meals. Do not take more than three
tablets per day.
• This product is not suitable for children
under 12 years of age and older with a
body weight of less than 35kg.
People with kidney problems
Your doctor may tell you to take a lower
dose or to take the medicine less often.
If you take more Domperidone Tablets
than you should
• If you have used or taken too many
Domperidone tablets, contact your
doctor, pharmacist, or the poisons
centre at your nearest hospital casualty
department immediately. Take the carton
and any tablets left with you. This is so
the doctors know what you have taken.
In the event of overdose, symptomatic
treatment could be implemented.
An ECG monitoring could be
undertaken, because of the possibility
of a heart problem called prolonged QT
interval.
• The signs of taking more than you
should include feeling sleepy, confused,
uncontrolled movements which include
unusual eye movements, unusual
movements of the tongue or abnormal
posture (such as a twisted neck)
If you forget to take Domperidone Tablets
• If you forgot to take Domperidone, take
it as soon as you remember.
• However If it is almost time for your next
dose, wait until that is due and continue
as normal.
• Do not take a double dose to make up
for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Domperidone Tablets
can have side effects, although not
everybody gets them.
Stop taking Domperidone and see your
doctor or go to a hospital straightaway if:
• You get swelling of the hands, feet,
ankles, face, lips or throat which
may cause difficulty in swallowing
or breathing. You could also notice
an itchy, lumpy rash (hives) or nettle
rash (urticaria). This may mean you
are having an allergic reaction to
Domperidone.
• You notice any uncontrolled movements.
These include irregular eye movements,
unusual movements of the tongue, and
abnormal posture such as a twisted
neck, trembling and muscle stiffness.
These symptoms should stop once you
stop taking Domperidone.
• You have a very fast or unusual
heartbeat. This could be a sign of a life-
threatening heart problem.
• You have a fit (seizure).
Other side effects include:
Common (may affect up to 1 in 10
people):
• Dry mouth
Uncommon (may affect up to 1 in 100
people):
• Lowering of sexual drive (libido) in men
• Feeling anxious
• Feeling agitated or irritable
• Feeling more nervous than usual
• Feeling drowsy
• Headaches
• Diarrhoea
• Itchy skin. You may also have a rash
• Unusual production of breast milk in men
and women
• Painful or tender breasts
• A general feeling of weakness
Not known (Frequency cannot be estimated
from the available data):
• Disorders of the cardiovascular system:
heart rhythm disorders (rapid or irregular
heart beat) have been reported; if this
happens, you should stop the treatment
immediately. Domperidone may be
associated with an increased risk of
heart rhythm disorder and cardiac arrest.
This risk may be more likely in those
over 60 years old or taking doses higher
than 30 mg per day. Domperidone
should be used at the lowest effective
dose.
• Abnormal eye movements
• Feeling the urge to move your legs, arms
or other parts of your body (restless
legs syndrome). These symptoms may
become worse in patients suffering from
Parkinson’s disease.
• Inability to urinate
• Breast enlargement in men
• In women, menstrual periods may be
irregular or stop
• A blood test shows changes in the way
your liver is working.
Some patients who have used Domperidone
for conditions and dosages requiring longer
term medical supervision have experienced
the following unwanted effects:
Restlessness; swollen or enlarged breasts,
unusual discharge from breasts, irregular
menstrual periods in women, difficulty
breastfeeding, depression, hypersensitivity.
Reporting of side effects
If you get any side effects, talk to your
doctor or 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 or search for
MHRA Yellow Card in the Google Play or
Apple App Store. By reporting side effects
you can help provide more information on
the safety of this medicine.
5. HOW TO STORE DOMPERIDONE
TABLETS
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the
original package.
Do not use the tablets after the expiry date
is stated on the label.
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. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Domperidone Tablets contain
The active substance is domperidone
maleate, 10mg per tablet.
The other ingredients are microcrystalline
cellulose, lactose monohydrate, maize
starch, povidone K30, sodium lauryl
sulphate, silica colloidal anhydrous,
magnesium stearate (see Section 2
‘Important information about some of the
ingredients of Domperidone Tablets’).
What Domperidone Tablets looks like
and contents of the pack
The tablets are white, round, biconvex and
uncoated with “Dm 10” marked on one side.
They are available in blister packs of 30 and
100 tablets.
Marketing Authorisation Holder:
Milpharm Limited
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD,
United Kingdom
Manufacturers:
Milpharm Limited
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD
United Kingdom
APL Swift Services (Malta) Ltd.,
HF26, Hal Far Industrial Estate,
Hal Far,Birzebbugia BBG 3000
This leaflet was last revised in
01/2024.
N08506XX
