DOMPERIDONE 1MG/ML SUSPENSION

Active substance: DOMPERIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MOTILIUM® 1MG/ML SUSPENSION
(domperidone)

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

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

You are allergic (hypersensitive) to domperidone or any of
the other ingredients of Motilium 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.
If you have or have had liver problems.

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

Take special care with Motilium Suspension and
check with your doctor or pharmacist before taking
this medicine if:
You have any kidney problems. If you take Motilium
Suspension over a long period, your doctor may want to
lower the amount you use.
This will depend on how severe your kidney problems are.

1. What Motilium Suspension is and what it
is used for

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

The name of your medicine is Motilium 1mg/ml Suspension (called
Motilium Suspension in this leaflet). The active ingredient in this
medicine is called domperidone. This belongs to a group of
medicines called ‘dopamine antagonists’.
Motilium Suspension 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 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. Motilium Suspension should be used at the lowest
effective dose in adults and children.

Motilium Suspension 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)

Other medicines and Motilium Suspension:

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 Suspension can affect the way some other
medicines work. Also, some medicines can affect the way Motilium
Suspension works.
Do not use Motilium Suspension 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).

Taking Motilium Suspension with food and drink

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

Page 1 of 2

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking Motilium
Suspension if:
You are pregnant, might become pregnant or think you may
be pregnant.
You are breast-feeding. It is best not to take Motilium
Suspension if you are breast-feeding. This is because small
amounts may pass into the mother’s milk.

Driving and using machines:

Motilium Suspension does not affect your ability to drive or use
machines.

Important information about some of the
ingredients of Motilium Suspension

This medicine contains sorbitol. If you have been told that you
cannot digest or tolerate some sugars, talk to your doctor before
taking Motilium 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 Motilium Suspension
Always take Motilium Suspension exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are
not sure.

Taking this medicine

Take this medicine by mouth.
Take your medicine using the plastic measuring cup
provided with Motilium Suspension.
This cup is marked in ml (millilitres) to help you measure out
the correct amount of this medicine.
Take your medicine 15 to 30 minutes before a meal and, if
needed, before you go to bed.

The usual dose is:

Adults and teenagers (over 12 years of age and who
weigh more than 35kg)
Take 10ml to 20ml of Motilium Suspension, three or four
times each day.
Do not take more than 80ml of Motilium Suspension a day.
Use in children (under 12 years of age and who weigh less
than 35kg)
Your doctor will work out the dose. This will depend on the
weight of your child. Do not give your child any more than
80ml of Motilium Suspension a day.

People with kidney problems

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

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 Suspension 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 Suspension than you
should:

If you have taken more Motilium Suspension than you
should, talk to a doctor or go to the nearest hospital
casualty department straight away. Take the carton and
bottle containing any remaining medicine 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 Suspension:

If you forget to take Motilium Suspension, 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 Suspension can have side effects,
although not everybody gets them.

Stop taking Motilium 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 Motilium 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. This is more likely to happen
in children. These symptoms should stop once you stop
taking Motilium Suspension.
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 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. Motilium Suspension 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 get
serious or last longer than a few days, or if you notice any side
effects not listed in this leaflet.

Reporting of 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 Suspension
Keep out of the sight and reach of children.
Do not store above 30˚C.
Do not take Motilium Suspension after the expiry date stated
on the pack.
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 Motilium Suspension contains

The active ingredient in Motilium Suspension is domperidone.
Each ml of the suspension contains 1mg of active ingredient
domperidone.
The other ingredients are:
sodium saccharin (E954), mirocrystalline cellulose (E460),
sodium carboxymethylcellulose (E466), sorbitol solution
(non crystallising) E420, methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216), polysorbate 20,
sodium hydroxide and purified water.
Page 2 of 2

What Motilium Suspension looks like and contents
of the pack

Motilium 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

Your medicine is 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): 20.11.13
Motilium® is a registered trademark of Johnson & Johnson.

PACKAGE LEAFLET: INFORMATION FOR THE USER

DOMPERIDONE 1MG/ML SUSPENSION
(domperidone)

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’.
Domperidone Suspension 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.

Domperidone Suspension 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)

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.
If you have or have had liver problems.

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.

Take special care with Domperidone Suspension
and check with your doctor or pharmacist before
taking this medicine if:

You have any kidney problems. If you take Domperidone
Suspension 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 Domperidone Suspension. Do
this even if they have applied in the past.
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 children.

Other medicines and Domperidone Suspension:

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 use Domperidone Suspension 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).

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.

Page 1 of 2

Pregnancy and breast-feeding

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. This is because small
amounts may pass into the mother’s milk.

Driving and using machines:

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
Always take Domperidone Suspension exactly as your doctor has
told you. You should check with your doctor or pharmacist if you
are not sure.

Taking this medicine

Take this medicine by mouth.
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.
Take your medicine 15 to 30 minutes before a meal and, if
needed, before you go to bed.

The usual dose is:

Adults and teenagers (over 12 years of age and who
weigh more than 35kg)
Take 10ml to 20ml of Domperidone Suspension, three or
four times each day.
Do not take more than 80ml of Domperidone Suspension a
day.
Use in children (under 12 years of age and who weigh less
than 35kg)
Your doctor will work out the dose. This will depend on the
weight of your child. Do not give your child any more than
80ml of Domperidone Suspension a day.

People with kidney problems

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

How long can I take this medicine for?

Your doctor will decide how long you will need to take this
medicine.
If you take Domperidone Suspension 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 Domperidone Suspension than you
should:
If you have taken more Domperidone Suspension than you
should, talk to a doctor or go to the nearest hospital
casualty department straight away. Take the carton and
bottle containing any remaining medicine 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 Domperidone Suspension:

If you forget to take Domperidone Suspension, 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, 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. This is more likely to happen
in children. 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.

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.

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 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 get
serious or last longer than a few days, or if you notice any side
effects not listed in this leaflet.

Reporting of 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 Domperidone Suspension
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.
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), mirocrystalline cellulose (E460),
sodium carboxymethylcellulose (E466), sorbitol solution
(non crystallising) E420, methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216), polysorbate 20,
sodium hydroxide and purified water.
Page 2 of 2

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

Your medicine is 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): 20.11.13

Expand view ⇕

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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