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MOTILIUM 10MG FILM-COATED TABLETS

Active substance: DOMPERIDONE MALEATE

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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. Motilium should be used at the lowest effective
dose in adults and children.

MOTILIUM 10 MG FILM-COATED TABLETS
Domperidone
PATIENT INFORMATION LEAFLET

Side effects such as feeling drowsy, nervous, agitated or irritable or having a fit
are more likely to happen in children.

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

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts
longer than a few days, or if you notice any side effects not listed in this leaflet.
5. HOW TO STORE MOTILIUM
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not take Motilium Tablets after the expiry date stated on the pack.
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.

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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

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Motilium 10mg Film-Coated Tablets contain
Each Motilium Tablet contains 10mg of domperidone (the active ingredient). It also
contains lactose, maize starch, microcrystalline cellulose, hypromellose,
pregelatinised starch, povidone, propylene glycol, magnesium stearate, silica
colloidal hydrated and polysorbate 20.
What Motilium 10mg Film-Coated Tablets look like and contents of the pack
Each pack contains 30 or 100 white to cream coloured, film-coated tablets with
Motilium stamped on one side.
Marketing Authorisation Holder is:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer is:
Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon,
Newcastle-upon-Tyne, Tyne & Wear, NE3 3TT.
This leaflet was last revised in: August 2013
Motilium® is a registered Trademark of Johnson & Johnson Inc.
‘Zentiva’ is a registered trademark © 2013 Zentiva

1. WHAT MOTILIUM IS AND WHAT IT IS USED FOR
The name of your medicine is Motilium 10mg Film-Coated Tablets (called Motilium
in this leaflet). Motilium contains a medicine called domperidone. This belongs to a
group of medicines called ‘dopamine antagonists’.
Motilium works by helping to move food faster through your food pipe
(oesophagus), stomach and gut. This is so that it does not stay in the same place
for too long. It also helps stop food flowing the wrong way back up your food pipe.
Motilium can be used for the following:
Adults
• To stop or prevent you feeling sick (nausea) or being sick (vomiting)
• To stop or prevent the feeling of fullness during or shortly after a meal
• To treat stomach discomfort, or heartburn caused by the flow of the stomach
contents back into your food pipe
Children
• To stop or prevent children feeling sick (nausea) or being sick (vomiting)
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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOTILIUM
Do not take Motilium tablets if:
• You are allergic (hypersensitive) to domperidone or any of the other ingredients of
Motilium 10mg Film-Coated Tablets (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.
• If you have or have had liver problems.
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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.
Take special care with Motilium and check with your doctor or pharmacist
before taking this medicine if:
• You have any kidney problems. If you take Motilium over a long period, your
doctor may want to lower the amount you use. This will depend on how severe
your kidney problems are
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. Motilium should be used at the lowest effective
dose in adults and children.
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 use Motilium and tell your doctor if you are taking any of the following:
• Ketoconazole tablets or liquid for fungal infections
• Antibiotics for infections (such as erythromycin)

How long can I take this medicine for?
Your doctor will decide how long you will need to take this medicine.
If you take Motilium tablets for more than 2 weeks your doctor may wish to see
you again. This is to check if you need to keep taking the treatment.
If you take more Motilium than you should:
• If you have taken more Motilium tablets than you should, talk to a doctor or go to
the nearest hospital casualty department straight away. Take the carton and any
tablets left with you. This is so the doctors know what you have taken.
• 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 time for the next dose, skip the missed dose.
• 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.

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 breast-feeding. This
is because small amounts may pass into the mother’s milk
Driving and using machines:
Motilium does not affect your ability to drive or use machines.
Important information about some of the ingredients of Motilium tablets
This medicine contains lactose. If you have been told that you cannot digest or
tolerate some sugars, talk to your doctor before taking Motilium.
3. HOW TO TAKE MOTILIUM

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 life-threatening
heart problem.
Other side effects include:
Rare (affects less than 1 in 1,000 people)
• Unusual production of breast milk in men and women
• Breast enlargement in men
• Lowering of sexual drive (libido) in men
• In women, menstrual periods may be irregular or stop
• Stomach problems, including mild stomach cramps.

Always take Motilium tablets exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Swallow the tablets whole with a drink of water.
• Take the tablets 15 to 30 minutes before a meal and, if needed, before you go
to bed.
• Do not crush or chew them.
The usual dose is:
• Adults and teenagers (over 12 years and who weigh more than 35 kg)
Take one or two Motilium tablets (10 or 20mg) 3 to 4 times a day.
Do not take more than 8 tablets (80 mg) in a day.
• Use in children
Do not give Motilium tablets to children under 12 years of age and weighing
less than 35kg.

People with kidney problems
Your doctor may tell you to take a lower dose or to take the medicine less often.

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Very rare (affects less than 1 in 10,000 people)
• Itchy skin. You may also have a rash
• A blood test shows changes in the way your liver is working.
• Headaches
• Feeling agitated or irritable
• Feeling more nervous than usual
• Fits
• Feeling drowsy

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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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