MOTILIUM 30MG SUPPOSITORIES

Active substance: DOMPERIDONE

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MOTILIUM 30 mg SUPPOSITORIES
Domperidone
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using 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.
In this leaflet:
1. What Motilium is and what it is used for
2. Before you use Motilium
3. How to use Motilium
4. Possible side effects
5. How to store Motilium
6. Further information

2. BEFORE YOU USE MOTILIUM
Do not use Motilium Suppositories if:
• You are allergic (hypersensitive) to domperidone or any of the other ingredients of Motilium Suppositories (see section 6: Further
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.
Do not use Motilium if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Motilium.
Take special care with Motilium and check with your doctor or pharmacist before using this medicine if:
• You have any kidney problems. If you use 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
• You have liver problems
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using 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.
Taking other medicines
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)
Children
Do not use Motilium Suppositories in children who weigh less than 15kg.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before using Motilium if:
• You are pregnant, might become pregnant or think you may be pregnant
• You are breast-feeding. It is best not to use Motilium if you are breast-feeding. This is because small amounts may pass into
the mother’s milk
Driving and using machines
You may feel sleepy, confused or have less control over your movements while using Motilium. If this happens, do not drive or
use any tools or machines.
Important information about some of the ingredients of Motilium Suppositories
This medicine contains butylated hydroxyanisole. This can cause irritation to the eyes, skin and just inside body passages (such
as the mouth and nose).
3. HOW TO USE MOTILIUM
Always use Motilium Suppositories exactly as your doctor has told you. You should check with your doctor or pharmacist if you
are not sure.
Motilium Suppositories are used by putting them into your back passage (rectum).
Using this medicine
• First wash your hands
• Take out the strip of suppositories.
• Tear off a section containing one suppository
• Find the pointed end of the wrapping and peel apart the plastic wrapping
• Remove the suppository from the wrapping
• Gently push the pointed end of the suppository into your back passage (rectum) with your finger
• Push the suppository in as far as possible

DUMMY

1. WHAT MOTILIUM IS AND WHAT IT IS USED FOR
The name of your medicine is Motilium 30mg Suppositories (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)

• Tighten your buttock muscles to stop the suppository coming out
• Wash your hands
The usual dose is:
• Adults and teenagers (over 12 years and who weigh more than 35 kg)
Use two 30 mg Motilium Suppositories twice a day
• Babies and Children who weigh more than 15 kg
Use one 30mg Motilium Suppository twice a day
People with kidney problems
Your doctor may tell you to use a lower dose or to use the medicine less often.
How long can I use this medicine for?
Your doctor will decide how long you will need to use this medicine.
If you use Motilium Suppositories for more than 4 weeks your doctor may wish to see you again. This is to check if you need to
keep using the treatment.
If you use more Motilium than you should
• If you have used more Motilium Suppositories than you should, talk to a doctor or go to the nearest hospital casualty
department straight away. Take the carton and any suppositories 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 use Motilium
• If you forget to use Motilium, use it as soon as you remember.
• However if it is time for the next dose, skip the missed dose.
• Do not use a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Motilium Suppositories can have side effects, although not everybody gets them.
Stop using 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 using 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
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
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.
Side effects such as feeling drowsy, nervous, agitated or irritable or having a fit are more likely to happen in children.
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 reach and sight of children.
Do not store above 25°C.
Do not use Motilium Suppositories 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.

6. FURTHER INFORMATION
What Motilium Suppositories contain
Each Motilum Suppository contains 30mg of domperidone (the active ingredient). It also contains macrogol, tartaric acid and
butylated hydroxyanisole.
What Motilium Suppositories looks like and contents of the pack
Each pack contains 10 white to slightly yellow suppositories.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder is:
Winthrop Pharmaceuticals
PO Box 611
GU1 4YS, UK
Manufacturer is:
Sofarimex - Industria Quimica e Farmacêutica Lda
Av. das Industrias - Alto do Colaride
Agualva
2735-213 Cacém
Portugal
This leaflet dose not contain all the information about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised in: January 2012
Motilium® is a Registered Trademark of Johnson & Johnson Inc. ‘Winthrop’ is a registered trademark
©2012 Winthrop Pharmaceuticals

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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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