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DOMPERIDONE 1MG/ML SUSPENSION

Active substance(s): DOMPERIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MOTILIUM® 1MG/ML SUSPENSION
(domperidone)

▼ This medicine is subject to additional

monitoring. This will allow quick identification of
new safety information. You can help by
reporting any side effects you may get. See the
end of section 4 for how to report side effects.

Read all of this leaflet carefully before you
start taking this medicine.
ƒ
ƒ
ƒ

ƒ

ƒ

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

1. What Motilium Suspension is and what it
is used for
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.
This medicine is used in adults and in children to treat nausea
(feeling sick) and vomiting (being sick).

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

ƒ
ƒ
ƒ

ƒ
ƒ
ƒ

ƒ
ƒ

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.
You have a moderate or severe liver disease.
Your ECG (electrocardiogram) shows a heart problem called
“prolonged QT corrected interval”.
You have or had a problem where your heart cannot pump
the blood around your body as well as it should (condition
called heart failure).
You have a problem that gives you a low level of potassium
or magnesium, or a high level of potassium in your blood.
You are taking certain medicines (see “Other medicines and
Motilium Oral Suspension”).

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.
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. The risk also increases when Motilium Suspension is
given together with some drugs. Tell your doctor or pharmacist if
you are taking drugs to treat infection (fungal infections or
bacterial infection) and/or if you have heart problems or AIDS/HIV
(see “Other medicines and Motilium Suspension”).
Motilium Oral Suspension should be used at the lowest effective
dose in adults and children.
While taking Motilium Suspension, contact your doctor if you
experience heart rhythm disorders such as palpitations, trouble
breathing, loss of consciousness. Treatment with Motilium Oral
Suspension should be stopped.

Follow these instructions closely unless your doctor has advised
you otherwise. You should check with your doctor or pharmacist if
you are not sure.

Duration of treatment

Your doctor will decide how long you will need to take this
medicine. Symptoms usually resolve with 3-4 days of taking this
medicine. Do not take Motilium Suspension for longer than 7 days
without consulting your doctor.

Taking this medicine
ƒ
ƒ

Take this medicine by mouth.
Adults and adolescents: 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.

ƒ

Children weighing under 35kg: should be given Motilium
Suspension using a suitably graduated oral syringe. Your
doctor or pharmacist will supply you with this syringe. If you
are not supplied with an oral syringe please speak to your
doctor or pharmacist.
Take your medicine 15 to 30 minutes before a meal.

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 take Motilium Suspension if you are taking medicine to
treat:
ƒ
Fungal infections such as azole anti-fungals, specifically oral
ketoconazole, fluconazole or voriconazole.
ƒ
Bacterial infections, specifically erythromycin,
clarithromycin, telithromycin, moxifloxacin, pentamidine
(these are antibiotics).
ƒ
Heart problems or high blood pressure (e.g., amiodarone,
dronedarone, quinidine, disopyramide, dofetilide, sotalol,
diltiazem, verapamil).
ƒ
Psychoses (e.g., haloperidol, pimozide, sertindole)
ƒ
Depression (e.g., citalopram, escitalopram)
ƒ
Gastro-intestinal disorders (e.g., cisapride, dolasetron,
prucalopride).
ƒ
Allergy (e.g., mequitazine, mizolastine).
ƒ
Malaria (in particular halofantrine).
ƒ
AIDS/HIV (protease inhibitors).
ƒ
Cancer (e.g., toremifene, vandetanib, vincamine)
Tell your doctor or pharmacist if you are taking drugs to treat
infection, heart problems or AIDS/HIV.
Tell your doctor if you are taking antacids or other medicines that
reduce stomach acid (such as cimetidine or sodium bicarbonate).
These medicines can be taken if you are also taking Motilium
Suspension but they should not be taken at the same time as they
may affect how well Motilium Suspension works. Medicines that
reduce stomach acid should be taken after a meal.

ƒ

The usual dose is:
ƒ

Adults and adolescents 12 years of age and older with
a body weight of 35kg or more
The usual dose is 10ml taken up to three times per day, if
possible before meals. Do not take more than 30 ml per day.

ƒ

Children and adolescents from birth to a body weight
of less than 35kg
Your doctor will work out the dose. This will depend on the
weight of your child. Give the dose maximum 3 times a day,
if possible before meals/feeding. Do not give more than 3
times in a 24 hour time period.

People with kidney problems

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

If you take more Motilium Suspension than you
should:
ƒ

ƒ

It is important to ask your doctor or pharmacist if Motilium
Suspension is safe for you when you are taking any other
medicines, including medicines obtained without prescription.

Taking Motilium Suspension with food and drink

ƒ
ƒ

Pregnancy and breast-feeding

ƒ

Talk to your doctor or pharmacist before taking Motilium
Suspension if:
ƒ
You are pregnant, might become pregnant or think you may
be pregnant.
ƒ
You are breast-feeding. It is best not to take Motilium Oral
Suspension if you are breast-feeding. Small amounts of
domperidone have been detected in breast-milk. Motilium
Suspension may cause unwanted side effects affecting the
heart in a breast-fed baby. Motilium Suspension should be
used during breast feeding only if your physician considers
this clearly necessary. Ask your doctor for advice before
taking this medicine.

Driving and using machines:

Warnings and precautions

Important information about some of the
ingredients of Motilium Suspension:

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

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.

Page 1 of 2

If you have used or taken too much Motilium Suspension,
contact your doctor, pharmacist or the poisons unit at your
nearest hospital casualty department immediately in
particular if a child has taken too much. Take the carton and
bottle containing any remaining medicine with you. This is
so the doctors know what you have taken. In the event of
overdose, symptomatic treatment could be implemented. An
ECG monitoring could be undertaken, because of the
possibility of a heart problem called prolonged QT interval.
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:

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

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.

Before taking this medicine contact your doctor if:
ƒ
You suffer from liver problems (liver function impairment or
failure) (see “Do not take Motilium Suspension if”)
ƒ
You suffer from kidney problems (kidney function
impairment or failure). It is advisable to ask your doctor for
advice in case of prolonged treatment as you may need to
take a lower dose or take this medicine less often, and your
doctor may want to examine you regularly.

3. How to take Motilium Suspension

If you forget to take Motilium Suspension, take it as soon as
you remember.
However if it is almost time for the next dose, wait until that
is due and then continue as normal.
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:
ƒ

ƒ

ƒ
ƒ

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.
You have a fit (seizure)

Other side effects include:
Common (affects less than 1 in 10 people)
ƒ

Dry mouth

Uncommon (affects less than 1 in 100 people)
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

Lowering of sexual drive (libido) in men
Feeling anxious
Feeling drowsy
Headaches
Diarrhoea
Itchy skin. You may also have a rash
Unusual production of breast milk in men and women
Painful or tender breasts
A general feeling of weakness

Not known (Frequency cannot be estimated from the
available data)
ƒ

ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

Disorders of the cardiovascular system: heart rhythm
disorders (rapid or irregular heart beat) have been reported;
if this happens, you should stop the treatment immediately.
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 30 mg per day.
Motilium Suspension should be used at the lowest effective
dose in adults and children.
Feeling agitated or irritable
Feeling more nervous than usual
Abnormal eye movements
Inability to urinate
Breast enlargement in men
In women, menstrual periods may be irregular or stop
A blood test shows changes in the way your liver is working.

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): 27.10.2014
Motilium® is a registered trademark of Johnson & Johnson.

Some patients who have used Motilium Suspension for conditions
and dosages requiring longer term medical supervision have
experienced the following unwanted effects: Restlessness; swollen
or enlarged breasts, unusual discharge from breasts,
irregular menstrual periods in women, difficulty breastfeeding,
depression, hypersensitivity.
Side effects such as feeling drowsy, nervous, agitated or irritable
or having a fit are more likely to happen in children.

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
ƒ
ƒ
ƒ
ƒ

ƒ

ƒ

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), microcrystalline cellulose (E460),
sodium carboxymethylcellulose (E466), sorbitol solution
(non crystallising) E420, methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216), polysorbate 20,
sodium hydroxide and purified water.

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.

Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

DOMPERIDONE 1MG/ML SUSPENSION
(domperidone)

▼ This medicine is subject to additional

monitoring. This will allow quick identification of
new safety information. You can help by
reporting any side effects you may get. See the
end of section 4 for how to report side effects.

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. The risk also increases when Domperidone
Suspension is given together with some drugs. Tell your doctor or
pharmacist if you are taking drugs to treat infection (fungal
infections or bacterial infection) and/or if you have heart problems
or AIDS/HIV (see “Other medicines and Domperidone
Suspension”).

Read all of this leaflet carefully before you
start taking this medicine.

Domperidone Oral Suspension should be used at the lowest
effective dose in adults and children.

ƒ
ƒ

While taking Domperidone Suspension, contact your doctor if you
experience heart rhythm disorders such as palpitations, trouble
breathing, loss of consciousness. Treatment with Domperidone
Oral Suspension should be stopped.

ƒ

ƒ

ƒ

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.
This medicine is used in adults and in children to treat nausea
(feeling sick) and vomiting (being sick).

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

ƒ
ƒ
ƒ

ƒ
ƒ
ƒ

ƒ
ƒ

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.
You have a moderate or severe liver disease.
Your ECG (electrocardiogram) shows a heart problem called
“prolonged QT corrected interval”.
You have or had a problem where your heart cannot pump
the blood around your body as well as it should (condition
called heart failure).
You have a problem that gives you a low level of potassium
or magnesium, or a high level of potassium in your blood.
You are taking certain medicines (see “Other medicines and
Domperidone Oral Suspension”).

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.

Warnings and precautions

Before taking this medicine contact your doctor if:
ƒ
You suffer from liver problems (liver function impairment or
failure) (see “Do not take Domperidone Suspension if”)
ƒ
You suffer from kidney problems (kidney function
impairment or failure). It is advisable to ask your doctor for
advice in case of prolonged treatment as you may need to
take a lower dose or take this medicine less often, and your
doctor may want to examine you regularly.

3. How to take Domperidone Suspension
Follow these instructions closely unless your doctor has advised
you otherwise. You should check with your doctor or pharmacist if
you are not sure.

Duration of treatment

Your doctor will decide how long you will need to take this
medicine. Symptoms usually resolve with 3-4 days of taking this
medicine. Do not take Domperidone Suspension for longer than 7
days without consulting your doctor.

Taking this medicine
ƒ
ƒ

Take this medicine by mouth.
Adults and adolescents: 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.

ƒ

Children weighing under 35kg: should be given
Domperidone Suspension using a suitably graduated oral
syringe. Your doctor or pharmacist will supply you with this
syringe. If you are not supplied with an oral syringe please
speak to your doctor or pharmacist.
Take your medicine 15 to 30 minutes before a meal.

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 take Domperidone Suspension if you are taking medicine
to treat:
ƒ
Fungal infections such as azole anti-fungals, specifically oral
ketoconazole, fluconazole or voriconazole.
ƒ
Bacterial infections, specifically erythromycin,
clarithromycin, telithromycin, moxifloxacin, pentamidine
(these are antibiotics).
ƒ
Heart problems or high blood pressure (e.g., amiodarone,
dronedarone, quinidine, disopyramide, dofetilide, sotalol,
diltiazem, verapamil).
ƒ
Psychoses (e.g., haloperidol, pimozide, sertindole)
ƒ
Depression (e.g., citalopram, escitalopram)
ƒ
Gastro-intestinal disorders (e.g., cisapride, dolasetron,
prucalopride).
ƒ
Allergy (e.g., mequitazine, mizolastine).
ƒ
Malaria (in particular halofantrine).
ƒ
AIDS/HIV (protease inhibitors).
ƒ
Cancer (e.g., toremifene, vandetanib, vincamine)
Tell your doctor or pharmacist if you are taking drugs to treat
infection, heart problems or AIDS/HIV.
Tell your doctor if you are taking antacids or other medicines that
reduce stomach acid (such as cimetidine or sodium bicarbonate).
These medicines can be taken if you are also taking Domperidone
Suspension but they should not be taken at the same time as they
may affect how well Domperidone Suspension works. Medicines
that reduce stomach acid should be taken after a meal.

ƒ

The usual dose is:
ƒ

Adults and adolescents 12 years of age and older with
a body weight of 35kg or more
The usual dose is 10ml taken up to three times per day, if
possible before meals. Do not take more than 30 ml per day.

ƒ

Children and adolescents from birth to a body weight
of less than 35kg
Your doctor will work out the dose. This will depend on the
weight of your child. Give the dose maximum 3 times a day,
if possible before meals/feeding. Do not give more than 3
times in a 24 hour time period.

People with kidney problems

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

If you take more Domperidone Suspension than you
should:
ƒ

ƒ

It is important to ask your doctor or pharmacist if Domperidone
Suspension is safe for you when you are taking any other
medicines, including medicines obtained without prescription.

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.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking Domperidone
Suspension if:
ƒ
You are pregnant, might become pregnant or think you may
be pregnant.
ƒ
You are breast-feeding. It is best not to take Domperidone
Oral Suspension if you are breast-feeding. Small amounts of
domperidone have been detected in breast-milk.
Domperidone Suspension may cause unwanted side effects
affecting the heart in a breast-fed baby. Domperidone
Suspension should be used during breast feeding only if your
physician considers this clearly necessary. Ask your doctor
for advice before taking this medicine.

Driving and using machines:

If you forget to take Domperidone Suspension:
ƒ
ƒ
ƒ

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:
ƒ

ƒ

ƒ

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.

ƒ

This medicine also contains methyl parahydroxybenzoate (E218)
and propyl parahydroxybenzoate (E216). These substances may
cause allergic reactions (possibly delayed), and exceptionally,
bronchospasm.

ƒ

Page 1 of 2

If you forget to take Domperidone Suspension, take it as
soon as you remember.
However if it is almost time for the next dose, wait until that
is due and then continue as normal.
Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

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

Important information about some of the
ingredients of Domperidone Suspension:

If you have used or taken too much Domperidone
Suspension, contact your doctor, pharmacist or the poisons
unit at your nearest hospital casualty department
immediately in particular if a child has taken too much. Take
the carton and bottle containing any remaining medicine
with you. This is so the doctors know what you have taken.
In the event of overdose, symptomatic treatment could be
implemented. An ECG monitoring could be undertaken,
because of the possibility of a heart problem called
prolonged QT interval.
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).

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.
You have a fit (seizure)

Other side effects include:
Common (affects less than 1 in 10 people)
Dry mouth

Uncommon (affects less than 1 in 100 people)

Manufacturer

ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Lowering of sexual drive (libido) in men
Feeling anxious
Feeling drowsy
Headaches
Diarrhoea
Itchy skin. You may also have a rash
Unusual production of breast milk in men and women
Painful or tender breasts
A general feeling of weakness

Not known (Frequency cannot be estimated from the
available data)
ƒ

ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

Disorders of the cardiovascular system: heart rhythm
disorders (rapid or irregular heart beat) have been reported;
if this happens, you should stop the treatment immediately.
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 30 mg per day.
Domperidone Suspension should be used at the lowest
effective dose in adults and children.
Feeling agitated or irritable
Feeling more nervous than usual
Abnormal eye movements
Inability to urinate
Breast enlargement in men
In women, menstrual periods may be irregular or stop
A blood test shows changes in the way your liver is working.

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.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0384

POM

Leaflet issue and revision date (Ref): 27.10.14

Some patients who have used Domperidone Suspension for
conditions and dosages requiring longer term medical supervision
have experienced the following unwanted effects: Restlessness;
swollen or enlarged breasts, unusual discharge from breasts,
irregular menstrual periods in women, difficulty breastfeeding,
depression, hypersensitivity.
Side effects such as feeling drowsy, nervous, agitated or irritable
or having a fit are more likely to happen in children.

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
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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), microcrystalline cellulose (E460),
sodium carboxymethylcellulose (E466), sorbitol solution
(non crystallising) E420, methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216), polysorbate 20,
sodium hydroxide and purified water.

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.

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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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