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DOMPERIDONE 1MG/ML SUSPENSION

Active substance(s): DOMPERIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

DOMPERIDONE 1MG/ML SUSPENSION
(domperidone)

▼ 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.









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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
Your doctor may have given you this medicine before
from another company. It may have looked slightly
different. However, either brand will have the same
effect.

In this leaflet:
1.
2.

3.
4.
5.
6.

What Domperidone Suspension is and what it is used for
What you need to know before you take Domperidone
Suspension
How to take Domperidone Suspension
Possible side effects
How to store Domperidone Suspension
Contents of the pack and other information

1. What Domperidone Suspension is and
what it is used for
The name of your medicine is Domperidone 1mg/ml
Suspension (called Domperidone Suspension in this leaflet).
The active ingredient in this medicine is called domperidone.
This belongs to a group of medicines called ‘dopamine
antagonists’.
This medicine is used in adults and in adolescents 12 years of
age and older to treat nausea (feeling sick) and vomiting
(being sick).

2. What you need to know before you take
Domperidone Suspension
Do not take Domperidone Suspension if:














You are allergic (hypersensitive) to domperidone or any
of the other ingredients of Domperidone Suspension
(listed in section 6: Contents of the pack and other
information). Signs of an allergic reaction include: a
rash, swallowing or breathing problems, swelling of your
lips, face, throat or tongue.
You have a tumour of the pituitary gland (prolactinoma).
You have a blockage or tear in your intestines.
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 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 around 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 Suspension”).

Do not take Domperidone Suspension if any of the above
applies to you. If you are not sure, talk to your doctor or
pharmacist before taking Domperidone Suspension.

Warnings and precautions

Pregnancy and breast-feeding

If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Domperidone
Suspension. Do this even if they have applied in the past.

Driving and using machines:

Before taking this medicine contact your doctor if:

You suffer from liver problems (liver function impairment
or failure) (see “Do not take Domperidone Suspension
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.

Domperidone Suspension 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 Suspension 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 Suspension”).
Domperidone Suspension should be used at the lowest
effective dose in adults and adolescents 12 years of age and
older.

Talk to your doctor or pharmacist before taking Domperidone
Suspension if:

You are pregnant, might become pregnant or think you
may be pregnant.

You are breast-feeding. It is best not to take
Domperidone Suspension if you are breast-feeding.
Small amounts of domperidone have been detected in breastmilk. Domperidone Suspension may cause unwanted side
effects affecting the heart in a breast-fed baby. Domperidone
Suspension should be used during breast feeding only if your
physician considers this clearly necessary. Ask your doctor for
advice before taking this medicine.
Domperidone Suspension does not affect your ability to drive
or use machines.

Important information about some of the
ingredients of Domperidone Suspension:

This medicine contains sorbitol. If you have been told that
you cannot digest or tolerate some sugars, talk to your doctor
before taking Domperidone Suspension.
This medicine also contains methyl parahydroxybenzoate
(E218) and propyl parahydroxybenzoate (E216). These
substances may cause allergic reactions (possibly delayed),
and exceptionally, bronchospasm.

3. How to take Domperidone Suspension

While taking Domperidone Suspension, contact your doctor if
you experience heart rhythm disorders such as palpitations,
trouble breathing and loss of consciousness. Treatment with
Domperidone Suspension should be stopped.

Follow these instructions closely unless your doctor has
advised you otherwise. You should check with your doctor or
pharmacist if you are not sure.

Other medicines and Domperidone Suspension:

Duration of treatment

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 Suspension can
affect the way some other medicines work. Also, some
medicines can affect the way Domperidone Suspension
works.
Do not take Domperidone Suspension 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 or AIDS/HIV.
Tell your doctor if you are taking antacids or other medicines
that reduce stomach acid (such as cimetidine or sodium
bicarbonate).
These medicines can be taken if you are also taking
Domperidone Suspension but they should not be taken at the
same time as they may affect how well Domperidone
Suspension works. Medicines that reduce stomach acid should
be taken after a meal.
Domperidone and apomorphine
Before you use domperidone 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 the apomorphine leaflet.
It is important to ask your doctor or pharmacist if
Domperidone Suspension is safe for you when you are taking
any other medicines, including medicines obtained without
prescription.

Taking Domperidone Suspension with food and
drink

It is recommended to take Domperidone Suspension before
meals as when taken after meals the absorption of the
medicine is slightly delayed.

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Your doctor will decide how long you will need to take this
medicine. Symptoms usually resolve within 3-4 days of taking
this medicine. Do not take Domperidone Suspension for
longer than 7 days without consulting your doctor.

Taking this medicine






Take this medicine by mouth.
Adults and adolescents: take your medicine using the
plastic measuring cup provided with Domperidone
Suspension. This cup is marked in ml (millilitres) to help
you measure out the correct amount of this medicine.
This product is not suitable for children under 12 years
of age.
Take your medicine 15 to 30 minutes before a meal.

The usual dose is:


Adults and adolescents 12 years of age and older
with a body weight of 35kg or more
The usual dose is 10ml taken up to three times per day,
if possible before meals. Do not take more than 30ml
per day.

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 Suspension than you
should:




If you have used or taken too much Domperidone
Suspension, contact your doctor, pharmacist or the
poisons unit at your nearest hospital casualty
department immediately. Take the carton and bottle
containing any remaining medicine 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 Suspension:




If you forget to take Domperidone Suspension, take it as
soon as you remember.
However if it is almost time for the next dose, wait until
that is due and then continue as normal.
Do not take a double dose to make up for a forgotten
dose.

4. Possible side effects

5. How to store Domperidone Suspension

Like all medicines, Domperidone Suspension can have side
effects, although not everybody gets them.





Stop taking Domperidone Suspension 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 Suspension.
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 Suspension.
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 (affects less than 1 in 10 people)


Dry mouth

Uncommon (affects less than 1 in 100 people)











Lowering of sexual drive (libido) in men
Feeling anxious
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 Suspension 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.
Domperidone Suspension should be used at the lowest
effective dose in adults and adolescents 12 years of age
and older
Feeling agitated or irritable
Feeling more nervous than usual
Abnormal eye movements
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 Suspension 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 and hypersensitivity.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.
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.







Keep out of the sight and reach of children.
Do not store above 30˚C.
Do not take Domperidone Suspension after the expiry
date stated on the pack. This refers to the last day of
that month.
If your medicine appears to be discoloured, or shows
any other signs of deterioration, take it to your
pharmacist who will advise you.
If your doctor tells you to stop taking the medicine,
please take it back to the pharmacist for safe disposal.
Only keep the medicine if your doctor tells you to.
Ask your pharmacist how to dispose of medicines you no
longer need. Do not dispose of medicines by flushing
down a toilet or sink, or by throwing them out with your
normal household rubbish. This will help to protect the
environment.

6. Contents of the pack and other
information
What Domperidone Suspension contains

The active ingredient in Domperidone Suspension is
domperidone. Each ml of the suspension contains 1mg of
active ingredient domperidone.
The other ingredients are:
sodium saccharin (E954), microcrystalline cellulose (E460),
sodium carboxymethylcellulose (E466),
sorbitol solution (non-crystallising) E420,
methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216), polysorbate 20,
sodium hydroxide and purified water.

What Domperidone Suspension looks like and
contents of the pack

Domperidone Suspension is a white homogenous oral
suspension.
The pack may include a 20ml measuring cup and a 1.25ml
plastic measuring spoon or a 20ml/4ml measuring device.
Your medicine is available in a white plastic bottle containing
200ml of the liquid suspension.

Manufacturer

Manufactured by:
Laboratorios Dr. Esteve S.A.,
Avda. Mare de Deu de Montserrat,
221 – 08041 Barcelona, Spain
or
Laboratorios Dr. Esteve S.A., C/Sant Marti,
s/n. Pol. Industrial La Roca,
08107 Martorelles, Barcelona, Spain.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe,
Northumberland, NE42 6PX.
PL No: 21828/0384

POM

Leaflet issue and revision date (Ref): 12.12.17

Blind or partially sighted?
Is this leaflet hard to see
or read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the
following information:
Product name:
Domperidone 1mg/ml
Suspension
Reference No: 21828/0384
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Further information

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