Skip to Content

DOMPERIDONE 10MG FILM-COATED TABLETS

Active substance(s): DOMPERIDONE MALEATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Domperidone 10mg Film-Coated Tablets
Domperidone maleate
▼ This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can help by
reporting any side effects you may get. See the end of section 4 for
how to report side effects.
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 again.
− If you have any further questions, please ask your doctor,
pharmacist or nurse.
− This medicine has been prescribed for you. 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Domperidone 10mg Film-Coated
Tablets are and what they are used for
2. What you need to know before you take
Domperidone 10mg Film-Coated Tablets
3. How to take Domperidone 10mg
Film-Coated Tablets
4. Possible side effects
5. How to store Domperidone 10mg
Film-Coated Tablets
6. Contents of the pack and other information
1. What Domperidone 10mg Film-Coated
Tablets are and what are they used for
The name of your medicine is Domperidone
10mg Film-Coated Tablets. Domperidone is an
anti-emetic which can stop you feeling sick.
The active ingredient is domperidone maleate.
This medicine is used in adults and in children
to treat nausea (feeling sick) and vomiting
(being sick).
2. What you need to know before you take
Domperidone 10mg Film-Coated Tablets
Do not take Domperidone 10mg Tablets
• if you are allergic to domperidone or any of
the other ingredients of this medicine (listed
in section 6)
• if you have or think you may have a serious
intestinal problem such as internal bleeding
(symptom being persistent black bowel
motions), or an obstruction or perforation of
the stomach or intestine (usually this involves
severe stomach cramps)
• if you suffer from a tumour of the pituitary
gland called prolactinoma
• if you have a moderate or severe liver disease
• if your ECG (electrocardiogram) shows a
heart problem called “prolonged QT corrected
interval”
• if 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)
• if you have a problem that gives you a low
level of potassium or magnesium, or a high
level of potassium in your blood.
• if you are taking certain medicines (see
“Other medicines and Domeperidone 10mg
Film-Coated Tablets”)
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before taking Domperidone 10mg
Film-Coated 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 suffer from liver problems (liver function
impairment or failure) (see “Do not take
Domperidone 10mg Tablets”)
• if you are taking a medicine called levodopa,
see ‘Other medicines and Domperidone
10mg Film-Coated Tablets’.
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 section other
medicines and Domeperidone 10mg
Film-Coated Tablets).
Domperidone should be used at the lowest
effective dose in adults and children.
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.
Children and adolescents
Do not give Domperidone 10mg Film-Coated
Tablets to children who weigh less than 35kg.
If Domperidone 10mg Film-Coated Tablets is
for a child, ask your doctor for the children's
formulation.
Other medicines and Domeperidone 10mg
Film-Coated Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Do not take Domperidone 10mg Film-Coated
Tablets if you are taking medicine to treat:
• fungal infections such as azole anti-fungals,
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)
• opioids, used to treat pain or as an analgesic
• ritonavir, used to treat virus infections.
Tell your doctor or pharmacist if you are taking
levodopa (a medicine used to treat the
symptoms of Parkinson's disease), drugs to
treat infection, heart problems or AIDS/HIV.
It is important to ask your doctor or pharmacist
if Domperidone 10mg Film-Coated Tablets are
safe for you when you are taking any other
medicines, including medicines obtained
without prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine. 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
You may have less control over your
movements whilst taking Domperidone Tablets.
If this happens do not drive or use any tools or
machines.
Domperidone 10mg Film-Coated Tablets
contain lactose and sodium
• Lactose: If you have been told by your doctor
that you have an intolerance to some sugars,
check with your doctor before taking
Domperidone 10mg Film-Coated Tablets.
• Sodium: This medicinal product contains 0.97
mmol (0.042 mg) of sodium per tablet. To be
taken into consideration by patients on a
controlled sodium dose.
If you have any doubts about whether you should
take this medicine then talk to your doctor.
3. How to take Domperidone 10mg
Film-Coated Tablets
These tablets have been prescribed for you by
a doctor. Always take this medicine exactly as
your doctor has told you. Check with your
doctor or pharmacist if you are not sure.

The tablets should be swallowed whole with a
sufficient quantity of liquid (e.g. one glass of
water).
Duration of treatment:
Symptoms usually resolve with 3-4 days of
taking this medicine. Do not take
Domperidone 10mg Film-Coated Tablets for
longer than 7 days without consulting your
doctor.
Adults and adolescents 12 years of age and
older with a body weight of 35kg or more
The recommended dose is one tablet taken up
to three times per day, if possible before meals.
Do not take more than three tablets per day.
If you take more Domperidone 10mg
Tablets than you should
If you have used or taken too much
Domperidone 10mg Film-Coated Tablets,
contact your doctor, pharmacist or the poison
centre immediately, in particular if a child has
taken too much. Take this leaflet and any
tablets you have left to show the doctor or
pharmacist. 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.
If you forget to take Domperidone 10mg
Tablets
Take your tablets as soon as you remember. 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.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
Serious side effects
Very rarely patients have experienced allergic
reactions to Domperidone.
If any of the following reactions occur, STOP
taking your Domperidone 10mg Film-Coated
Tablets and either tell your doctor immediately
or go to your nearest hospital:
• Palpitations or dizziness or changes to heart
traces (ECG) indicating a heart problem
• Facial or neck swelling, flushing or fainting
• Problems with breathing including shortness
of breath and wheezing
• Rash and itching (hives) or nettle rash
(urticaria)
• Other allergic reactions such as anaphylactic
reaction and shock
• 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. This is more
likely to happen in children. These symptoms
should stop once you stop taking
Domperidone 10mg Film-Coated Tablets.
• In exceptional cases mild stomach cramps
can occur, but these should go away quickly.
Other side effects
Uncommon: may affect up to 1 in 100
people
• Breast pain
Rare: may affect up to 1 in 1,000 people
• Unusual production of breast milk in men and
women
• Disruption of menstrual flow
• Breast growth in men
Very rare: may affect up to 1 in 10,000
people
• Agitation
• Nervousness
• Convulsions (fits)
• Drowsiness
• Headache
• Diarrhoea
• Abnormal liver function test
Not known: frequency cannot be estimated
from the available data
• reduced libido
• abnormal movements (muscle spasms
causing twisting or repetitive movements)
• a worsening of restless leg syndrome in
patients with Parkinson’s disease.
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 in adults and
children.
Side effects more likely to occur in children
include
convulsions (fits)
agitation and
drowsiness.
Stop taking
Domperidone
10mg Tablets and
tell your doctor as
soon as possible if
you experience
any of the above very rare side effects.
If you notice any side effects not mentioned in
this leaflet, or if you suffer from any of the side
effects listed please inform your doctor or
pharmacist.
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 Domperidone 10mg
Film-Coated Tablets
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date
printed on the package. The expiry date
refers to the last day of that month.
• If you have any tablets that are out of date,
please return them to your pharmacist for
disposal.
• Do not store above 25°C. Store the tablets in
the original package. Do not transfer
Domperidone 10mg Film-Coated tablets to
another container.
Do not throw away medicines via wastewater
or household waste. Ask your pharmacist how
to throw away medicines you no longer use.
These measures will help protect the
environment.
6. Contents of the pack and other
information
What Domperidone 10mg Tablets contain
The active ingredient is domperidone maleate.
Each tablet contains 10mg domperidone as
domperidone maleate.
Other ingredients in your tablets are lactose,
pregelatinised maize starch, microcrystalline
cellulose, sodium starch glycollate, magnesium
stearate and Opadry white OY-S-28899 which
consists of hypromellose, titanium dioxide
(E171) and macrogol.
What Domperidone 10mg Tablets look like
and contents of the pack
Domperidone 10mg Film-Coated tablets are
white, circular, film coated tablets marked DM
on one face, 10 on the reverse.
Domperidone 10mg Tablets are available in
cartons of 30 or 100 tablets. Not all pack sizes
may be marketed.
Marketing Authorisation Holder:
Wockhardt UK Limited, Ash Road North,
Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited,
Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:
0800 198 5000 (UK Only).
Please be ready to give the following
information:
Product name
Domperidone 10mg
Film-Coated Tablets

Reference
number
29831/0076

This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in 04/2016

104110/5
222242

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