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MOTILIUM 10

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GB - AW_81086

domperidone
■ This medicine is used for two reasons, which have different treatment
durations. See Section 1 ▶
■ This medicine is for use by adults and children aged 16 years and over.
■ Do not take this medicine:
■ There are some people who should not use this medicine. To find out if
you are one of them. See Section 2 ▶
■ If you have ever had a bad reaction to any of the ingredients. For the list
of ingredients. See Section 6 ▶
■ Speak to your doctor:
■ If you suffer from any of the conditions mentioned in Section 2 ▶
■ If you are taking any other medicines. See Section 2 ▶
■ Follow the dosage instructions carefully. These are shown in the
dosage table. See Section 3 ▶
Now read this whole leaflet carefully before you use this medicine.
Keep the leaflet: you might need it again.

1 What the medicine is for

Motilium 10 is a medicine which is used for two reasons, which have
different treatment durations:
■ To treat short lived episodes of nausea (feeling sick or queasy) and
vomiting (being sick) of less than 48 hours duration.
■ To relieve nausea, fullness, belching, heavy bloated stomach,
trapped wind and heartburn which can happen after a meal for
treatment periods of up to 2 weeks. This may be because the stomach’s
digestive rhythm has slowed down and is not moving food contents in the
right direction through the digestive system as efficiently as it needs to.
The tablets contain domperidone maleate, which works by helping your
stomach to move food contents through your digestive system normally and
in the right direction, so that they don’t stay too long in one place.
This medicine is for use in adults and children aged 16 years and over.

2 Before taking this medicine

This medicine is suitable for most adults and children aged 16 years and
over, but a few people should not use it. If you are in any doubt, talk to your
doctor or pharmacist.

Do not take this medicine…

■ If you have ever had a bad reaction to any of the ingredients.
■ If you have a disease of the pituitary gland (prolactinoma).
■ If you have ever had heart problems including heart failure,
a previous heart attack, angina (chest pains), or heart rhythm
disorders including a rapid or slow or irregular heartbeat, without first
consulting your doctor.
■ If you have an underlying illness affecting the digestive system,
for example:
■ A stomach or duodenal ulcer.
■ A blocked or perforated gut.
■ Your bowel motions (stools) are often black.
■ You frequently have severe stomach cramps.
■ If you have kidney or liver problems.
■ If you are taking any of the following medicines:
■ Oral ketoconazole (an antifungal medicine when taken by mouth).
■ Oral erythromycin (an antibiotic).
If any of these apply to you, get advice from a doctor or pharmacist
without taking Motilium 10.

Talk to your doctor or pharmacist…

■ If you have been told by your doctor that you have an intolerance
to some sugars.
■ If you are taking any other medicines including,
■ Anticholinergics (medicines used to relieve stomach cramps
or spasms) as they may affect how well Motilium 10 works.
If you are not sure about any of the medicines you are taking,
show the bottle or pack to your pharmacist.
■ 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.
If any of these bullet points apply to you now or in the past, talk to a doctor
or pharmacist.

If you are pregnant or breast-feeding

■ Do not take if you are pregnant or think you might be pregnant.
Do not take this medicine if you are breast-feeding unless your doctor
or another health care professional has told you to.



Some of the ingredients can cause problems

■ This medicine contains lactose. If you have been told by your doctor
that you have an intolerance to some sugars contact your doctor
before taking this medicinal product.

This product should not be used to treat travel sickness.
Speak to your doctor or pharmacist about suitable treatments.

Special warnings about use in travel sickness



3 How to take this medicine

Check the tables that follow to see how much medicine to take.
■ For oral use only.
■ Do not use more than the stated dose shown in the tables.
■ The tablets are for short term treatment only.
■ If symptoms of nausea (feeling sick) and vomiting (being sick) persist for
more than 48 hours, talk to your doctor.
If symptoms of stomach discomfort which occur after a meal persist for
more than 2 weeks, talk to your doctor.



Children under 16 years old

Do not give to children under 16 years old.

Adults and children 16 years and over

Dose

To treat nausea (feeling sick) and vomiting (being sick) of less
than 48 hours duration

Age

turn over ▶

Adults and children aged Take one tablet up to 3 times a day and one
16 years and over
tablet at night.
■ Do not take more than 4 tablets in any 24 hour period.
■ If your symptoms get worse or the tablets have no effect, talk to your doctor.
■ If symptoms of nausea and vomiting persist for more than 48 hours, talk
to your doctor.

AW_81086.pdf - Page 1 of 3 - October 12, 2012 - 08:11:30

Adults and children aged
16 years and over

AW_81086.pdf - Page 2 of 3 - October 12, 2012 - 08:11:30

You should only take this medicine as required following the dosage
instructions above carefully. If you forget to take a dose, take the next
dose when needed as long as you do not take more than 4 tablets in
any 24 hour period. Do not take a double dose.

If you forget to take the medicine

If anyone takes too many Motilium 10 tablets, contact a doctor or your
nearest Accident and Emergency department (Casualty) taking this
leaflet and pack with you.

If anyone takes too much





Fits or seizures.
Involuntary movements of the face or arms and legs, excessive trembling,
excessive muscle stiffness or muscle spasm.
■ Allergic reactions: signs of allergy include rash (such as hives), itching,
shortness of breath, wheezing and or swollen face or neck, flushing or fainting.
Very rarely (less than 1 in 10,000 people)
■ Heart rhythm disorders.

If you experience any of the following, stop using the
medicine and seek immediate medical help:

Motilium 10 tablets can have side-effects, like all medicines, although these
don’t affect everyone and are usually mild.

4 Possible side-effects





Do not take more than 4 tablets in any 24 hour period.
If your symptoms get worse or the tablets have no effect, talk to your doctor.
■ If your symptoms of stomach discomfort which occurs after a meal
persist for more than 2 weeks, talk to your doctor.

Dose

Take one tablet up to 3 times a day and
one tablet at night.

Age

To treat stomach discomfort and nausea experienced after food
and drink for up to 2 weeks

Adults and children 16 years and over

Keep the product out of the reach and sight of children.
Do not use your medicine after the date shown as the expiry date on the
packaging.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

5 Storing this medicine





Hives.
Agitation or nervousness.
■ Eye movement disorder.
■ Inability to urinate.
■ Swollen breasts (even in men).
■ Stop in menstrual periods.
■ Changes in certain laboratory test results. If you have a blood test to
check your liver function tell your doctor or nurse that you are taking
Motilium 10.
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.
If you experience any side-effects not included in this leaflet or are not sure
about anything, talk to your doctor or pharmacist.

Other side effects which occur but it is unknown how often:

Common (less than 1 in 10 people)
■ Dry mouth.
Uncommon (less than 1 in 100 people)
■ Anxiety.
■ Loss of interest in sex or diminished interest in sex.
■ Sleepiness or headache.
■ Diarrhoea.
■ Rash or itchiness
■ Painful or tender breasts, or discharge from breasts
■ A general feeling of weakness.

If you experience any of the following, stop using the
medicine and talk to your doctor:

11-0404
GB - AW_81086

The type of nausea or upset stomach treated by Motilium 10 can be caused
or aggravated by:
■ Overeating, or very large meals.
■ Eating too quickly.
■ Certain ‘triggers’ such as coffee, fatty foods, or alcohol.
There are things you can do to help stop future attacks of this type
of stomach problem:
Keep away from your ‘triggers’. If there are certain foods, drinks or situations
that you know bring on your symptoms try to cut them out or cut down.
Go easy on snacks. Snack foods often contain a lot of fat, and can make
your symptoms worse.
Eat regularly. Have three or four meals a day, at the same times, and don’t
rush your meals.

7 What you can do to help stop these symptoms

Motilium 10 are off-white film coated tablets available in packs of 10 tablets.
Product Licence holder:
McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer:
Janssen-Cilag, Domaine de Maigremont, 27100 Val de Reuil, France.
This leaflet was revised September 2012.
Motilium 10 is a registered trade mark.

What the medicine looks like

The active ingredient in Motilium 10 is: Domperidone maleate 12.72 mg,
which is equivalent to 10 mg domperidone.
Other ingredients are: Lactose, maize starch, microcrystalline cellulose,
pregelatinised potato starch, polyvidone, magnesium stearate, colloidal
silicon dioxide, polysorbate 20, hypromellose and propylene glycol.

What’s in this medicine?

6 Further information

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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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