DOMPERIDONE 1MG/ML ORAL SUSPENSION

Active substance: DOMPERIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Domperidone 1mg/ml Oral Suspension
(domperidone)
Your medicine is known as the above but will be referred to as
Domperidone throughout the remainder of this 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 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. What domperidone is and what it is used for
2. What you need to know before you take domperidone
3. How to take domperidone
4. Possible side effects
5. How to store domperidone
6. Contents of the pack and other information
1.

WHAT DOMPERIDONE IS AND WHAT IT IS USED
FOR

The active ingredient in this medicine is called domperidone.
This belongs to a group of medicines called ‘dopamine
antagonists’.
Domperidone 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 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

Do not take domperidone if:
 You are allergic (hypersensitive) to domperidone or any of
the other ingredients of Domperidone (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.
Do not take domperidone if any of the above applies to you. If
you are not sure, talk to your doctor or pharmacist before taking
domperidone.

Take special care with domperidone and check with your
doctor or pharmacist before taking this medicine if:
 You have any kidney problems. If you take domperidone
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 taking domperidone. Do this even if
they have applied in the past.
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 30mg
per day. Domperidone should be used at the lowest effective
dose in adults and children.
Other medicines and domperidone:
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 can
affect the way some other medicines work. Also, some
medicines can affect the way domperidone works.
Do not use 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 with food and drink
It is recommended to take domperidone before meals as when
taken after meals the absorption of the medicine is slightly
delayed.

The usual dose is:
 Adults and teenagers (over 12 years of age and who weigh
more than 35kg)
Take 10ml to 20ml of the suspension, three or four times
each day.
Do not take more than 80ml of Domperidone Oral
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 80
ml of Domperidone Oral 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 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 than you should:
 If you have taken more domperidone 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).

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

If you forget to take domperidone:
 If you forget to take domperidone, 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.

Driving and using machines:
Domperidone does not affect your ability to drive or use
machines.

Like all medicines, domperidone can have side effects, although
not everybody gets them.

Important information about some of the ingredients of
Domperidone Oral 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.
This medicine also contains methylhydroxybenzoate (E218) and
propylhydroxybenzoate (E216). These substances may cause
allergic reactions (possibly delayed), and exceptionally,
bronchospasm.
3.

HOW TO TAKE DOMPERIDONE

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 Oral 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.

4.

POSSIBLE SIDE EFFECTS

Stop taking domperidone 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.
 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.
 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 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 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.
5.





6.

HOW TO STORE DOMPERIDONE
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30°C.
Do not take Domperidone 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.
FURTHER INFORMATION

What Domperidone contains
 Domperidone 1mg/ml Oral Suspension contains
domperidone (the active ingredient).
 It also contains sodium saccharin (E954), microcrystalline
cellulose (E460), carmellose sodium (E466), sorbitol liquid
non-crystallising (E420), Methyl parahydroxybenzoate
(E218), Propyl parahydroxybenzoate (E216), polysorbate
20, sodium hydroxide and water.
What Domperidone looks like and contents of the pack
White coloured liquid suspension in a white plastic bottle with a
child resistant cap and a 20ml measuring cup.
Manufacturer
Manufactured by Laboratorios Dr, Esteve, S.A. C/Sant Marti,
s/n. Pol. Industrial La Roca, 08107 Barcelona.
Procured from within the EU and repackaged by the Product
Licence Holder: G Pharma Ltd., Salford M50 2PU.
PL 16369/1532

POM

Leaflet Revision: 15/10/2013

PACKAGE LEAFLET: INFORMATION FOR THE USER
Domperidone 1mg/ml Oral Suspension
(domperidone)
Your medicine is known as the above but will be referred to as
Domperidone throughout the remainder of this 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 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. What domperidone is and what it is used for
2. What you need to know before you take domperidone
3. How to take domperidone
4. Possible side effects
5. How to store domperidone
6. Contents of the pack and other information
1.

WHAT DOMPERIDONE IS AND WHAT IT IS USED
FOR

The active ingredient in this medicine is called domperidone.
This belongs to a group of medicines called ‘dopamine
antagonists’.
Domperidone 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 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

Do not take domperidone if:
 You are allergic (hypersensitive) to domperidone or any of
the other ingredients of Domperidone (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.
Do not take domperidone if any of the above applies to you. If
you are not sure, talk to your doctor or pharmacist before taking
domperidone.

Take special care with domperidone and check with your
doctor or pharmacist before taking this medicine if:
 You have any kidney problems. If you take domperidone
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 taking domperidone. Do this even if
they have applied in the past.
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 30mg
per day. Domperidone should be used at the lowest effective
dose in adults and children.
Other medicines and domperidone:
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 can
affect the way some other medicines work. Also, some
medicines can affect the way domperidone works.
Do not use 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 with food and drink
It is recommended to take domperidone before meals as when
taken after meals the absorption of the medicine is slightly
delayed.

The usual dose is:
 Adults and teenagers (over 12 years of age and who weigh
more than 35kg)
Take 10ml to 20ml of the suspension, three or four times
each day.
Do not take more than 80ml of Domperidone Oral
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 80
ml of Domperidone Oral 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 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 than you should:
 If you have taken more domperidone 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).

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

If you forget to take domperidone:
 If you forget to take domperidone, 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.

Driving and using machines:
Domperidone does not affect your ability to drive or use
machines.

Like all medicines, domperidone can have side effects, although
not everybody gets them.

Important information about some of the ingredients of
Domperidone Oral 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.
This medicine also contains methylhydroxybenzoate (E218) and
propylhydroxybenzoate (E216). These substances may cause
allergic reactions (possibly delayed), and exceptionally,
bronchospasm.
3.

HOW TO TAKE DOMPERIDONE

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 Oral 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.

4.

POSSIBLE SIDE EFFECTS

Stop taking domperidone 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.
 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.
 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 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 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.
5.





6.

HOW TO STORE DOMPERIDONE
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30°C.
Do not take Domperidone 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.
FURTHER INFORMATION

What Domperidone contains
 Domperidone 1mg/ml Oral Suspension contains
domperidone (the active ingredient).
 It also contains sodium saccharin (E954), microcrystalline
cellulose (E460), carmellose sodium (E466), sorbitol liquid
non-crystallising (E420), Methyl parahydroxybenzoate
(E218), Propyl parahydroxybenzoate (E216), polysorbate
20, sodium hydroxide and water.
What Domperidone looks like and contents of the pack
White coloured liquid suspension in a white plastic bottle with a
child resistant cap and a 20ml measuring cup.
Manufacturer
Manufactured by Laboratorios Dr, Esteve, S.A. C/Sant Marti,
s/n. Pol. Industrial La Roca, 08107 Barcelona.
Procured from within the EU and repackaged by the Product
Licence Holder: G Pharma Ltd., Salford M50 2PU.
PL 16369/1532

POM

Leaflet Revision: 15/10/2013

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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