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MOTILIUM 1MG/ML ORAL SUSPENSION

Active substance(s): DOMPERIDONE

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Motilium® 1 mg/ml Oral 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.
This product is available using the above name but will be referred to as
Motilium throughout the following:
Patient Information Leaflet
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.
• 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) What Motilium is and what it is used for
2) What you need to know before you take Motilium
3) How to take Motilium
4) Possible side effects
5) How to store Motilium
6) Contents of the pack and other information
HAT IT IS USED OR

1) What Motilium is and what it is used for
The name of your medicine is Motilium 1mg/ml Oral Suspension. 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 children to treat nausea (feeling
sick) and vomiting (being sick).
2) What you need to know before you take Motilium
Do not take Motilium if:
• You are allergic (hypersensitive) to domperidone or any of the other
ingredients of Motilium 1mg/ml Oral 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
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 Motilium”)
Do not take Motilium if any of the above applies to you. If you are not
sure, talk to your doctor or pharmacist before taking Motilium.
Warnings and precautions
Before taking this medicine contact your doctor if:
• You suffer from liver problems (liver function impairment or failure) (see
“Do not take Motilium 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 Motilium. Do this even if they have applied in the
past.
Motilium 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
Motilium 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).
Motilium should be used at the lowest effective dose in adults and
children.
While taking Motilium, contact your doctor if you experience heart rhythm
disorders such as palpitations, trouble breathing, loss of consciousness.
Treatment with Motilium should be stopped.
Other medicines and Motilium:
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 Motilium can
affect the way some other medicines work. Also, some medicines can
affect the way Motilium works.
Do not take Motilium 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)
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 Motilium but they should not
be taken at the same time as they may affect how well Motilium works.
Medicines that reduce stomach acid should be taken after a meal.
It is important to ask your doctor or pharmacist if Motilium is safe for you
when you are taking any other medicines, including medicines obtained
without prescription.
Taking Motilium with food and drink
It is recommended to take Motilium 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 Motilium if:
• You are pregnant, might become pregnant or think you may be
pregnant
• You are breast-feeding. It is best not to take Motilium if you are breastfeeding.
Small amounts of Motilium have been detected in breast-milk. Motilium
may cause unwanted side effects affecting the heart in a breast-fed baby.
Motilium 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:
Motilium does not affect your ability to drive or use machines
Important information about some of the ingredients of Motilium:
This medicine contains sorbitol. If you have been told that you cannot
digest or tolerate some sugars, talk to your doctor before taking Motilium.
This medicine also contains methylhydroxybenzoate (E218) and
propylhydroxybenzoate (E216). These substances may cause allergic
reactions (possibly delayed), and exceptionally, bronchospasm. T

O TAKE

3) How to take Motilium
Follow these instructions closely unless your doctor has advised you
otherwise. 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 Motilium 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 Motilium. This cup is marked in ml
(millilitres) to help you measure out the correct amount of this medicine.
• Children weighing under 35kg: should be given Motilium using a
suitably graduated oral syringe. Your doctor or pharmacist will supply
you with this syringe. If you are not supplied with an oral syringe please
speak to your doctor or pharmacist.
• 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 35 kg or more The usual dose is 10 ml taken up to three
times per day, if possible before meals. Do not take more than 30 ml
per day.
• Children and adolescents from birth to a body weight of less than
35kg
Your doctor will work out the dose. This will depend on the weight of
your child. Give the dose maximum 3 times a day, if possible before
meals/feeding. Do not give more than 3 times in a 24 hour time period.
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 Motilium than you should:
• If you have used or taken too much Motilium, contact your doctor,
pharmacist or the poisons unit at your nearest hospital casualty
department immediately in particular if a child has taken too much. 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 (especially in children) which
include unusual eye movements, unusual movements of the tongue or
abnormal posture (such as a twisted neck).
If you forget to take Motilium:
• If you forget to take Motilium, 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
Like all medicines, Motilium can have side effects, although not
everybody gets them.
Stop taking Motilium 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 Motilium.
• 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 Motilium.
• You have a very fast or unusual heartbeat. This could be a sign of a lifethreatening 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. Motilium 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. Motilium should be used at the lowest effective dose in
adults and children.
• 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 Motilium 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.
Side effects such as feeling drowsy, nervous, agitated or irritable or
having a fit are more likely to happen in children.
Reporting 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 Motilium





Keep out of the sight and reach of children.
Do not take Motilium after the expiry date stated on the pack.
Do not store above 30°C.
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.
• If the medicine become discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.

6) Contents of the pack and other information
What Motilium contains
Each ml of oral suspension contains 1mg of domperidone (the active
ingredient). It also contains sorbitol (E420), microcrystalline cellulose
(E460), carmellose sodium (E466), methylparahydroxybenzoate (E218),
propylparahydroxybenzoate (E216), sodium saccharin (E954),
polysorbate 20, sodium hydroxide and purified water.
What Motilium looks like and contents of the pack
Each pack contains a 200 millilitre bottle of a white homogenous oral
suspension in a white plastic bottle with a child resistant cap and a dual
measuring cup.
PL 10383/1741

Motilium® 1mg/ml Oral Suspension

POM

This medicine is manufactured by 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 the Product Licence
holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road,
Northolt, Middlesex, UB5 5QS
Leaflet Date: 20.07.2015
Motilium® is a registered Trademark of Johnson & Johnson Inc., USA.

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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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