DOMPERIDONE 1MG/ML ORAL SUSPENSION

Active substance: DOMPERIDONE

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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.
• 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.

1. What Motilium Oral Suspension is and what it is used for
The name of your medicine is Motilium 1mg/ml Oral Suspension (called Motilium Oral Suspension in this leaflet). The active
ingredient in this medicine is called domperidone. This belongs to a group of medicines called ‘dopamine antagonists’.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 180 x 429

In this leaflet:
1. What Motilium Oral Suspension is and what it is used for
2. What you need to know before you take Motilium Oral Suspension
3. How to take Motilium Oral Suspension
4. Possible side effects
5. How to store Motilium Oral Suspension
6. Contents of the pack and other information

Motilium Oral 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).

PROOF HISTORY:
v.3 - waymade - 18/09/14

2. What you need to know before you take Motilium Oral Suspension
Do not take Motilium Oral Suspension if:
• You are allergic (hypersensitive) to domperidone or any of the other ingredients of Motilium Oral 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 round 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”)

WARNING!

27mm

MOTILIUM® 1mg/ml Oral Suspension
(Motilium)
Patient Information Leaflet

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000F

Motilium Oral 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 Oral
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 Oral
Suspension).

UK PIL DATED SEPTEMBER 2014
REPORTING OF SIDE EFFECTS

06464/2814F
CODE:

DATE OF PROOF:

18/09/14

Other medicines and Motilium Oral 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 Oral Suspension can affect the way some other
medicines work. Also, some medicines can affect the way Motilium Oral Suspension works.

Motilium 1mg/ml oral suspension

ARTWORKER:

DT

DATE:

While taking Motilium Oral 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.

PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

04-1957

Q.A.
APPROVED:

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

Do not take Motilium Oral Suspension if you are taking medicine to treat:
• Fungal infections such as azole anti-fungals, specifically oral ketoconazole, fluconazole or voriconazole.
• Bacterial infections, specifically erythromycin, clarithromycin, telithromycin, moxifloxacin, pentamidine (these are
antibiotics)
• Heart problems or high blood pressure (e.g., amiodarone, dronedarone, quinidine, disopyramide, dofetilide, sotalol,
diltiazem, verapamil)
• Psychoses (e.g., haloperidol, pimozide, sertindole)
• Depression (e.g., citalopram, escitalopram)
• Gastro-intestinal disorders (e.g., cisapride, dolasetron, prucalopride)
• Allergy (e.g., mequitazine, mizolastine)
• Malaria (in particular halofantrine)
• AIDS/HIV (protease inhibitors)
• 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 Oral Suspension but they should not be taken at the same time as
they may affect how well Motilium Oral Suspension works. Medicines that reduce stomach acid should be taken after a meal.
It is important to ask your doctor or pharmacist if Motilium Oral Suspension is safe for you when you are taking any other
medicines, including medicines obtained without prescription.
Taking Motilium Oral Suspension with food and drink
It is recommended to take Motilium Oral 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 Motilium Oral 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 Oral Suspension if you are breast-feeding.
Small amounts of domperidone have been detected in breast-milk. Motilium Oral Suspension may cause unwanted side effects
affecting the heart in a breast-fed baby. Motilium Oral 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:
Motilium Oral Suspension does not affect your ability to drive or use machines.
Important information about some of the ingredients of Motilium 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 Motilium Oral Suspension.
This medicine also contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216). These substances may cause
allergic reactions (possibly delayed), and exceptionally, bronchospasm.

WARNING!

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Warnings and precautions
Before taking this medicine contact your doctor if:
• You suffer from liver problems (liver function impairment or failure) (see “Do not take Motilium Oral Suspension if”)
• 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.

DATE:

CUSTOMER
APPROVED:

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




Children weighing under 35kg: should be given Motilium Oral 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.

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

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 180 x 429



PROOF HISTORY:
v.3 - waymade - 18/09/14

If you take more Motilium Oral Suspension than you should:
• If you have used or taken too much Motilium Oral 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 Oral Suspension:
• If you forget to take Motilium Oral 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 Oral Suspension can have side effects, although not everybody gets them.

DATE:

Other side effects include:
Common (affects less than 1 in 10 people)
• Dry mouth
Uncommon (affects less than 1 in 100 people)
• 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

18/09/14
DATE OF PROOF:

Some patients who have used Motilium Oral 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.

UK PIL DATED SEPTEMBER 2014
REPORTING OF SIDE EFFECTS

Side effects such as feeling drowsy, nervous, agitated or irritable or having a fit are more likely to happen in children.

06464/2814F

DT

DATE:

Not known (Frequency cannot be estimated from the available data)
• 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 Oral 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 Oral 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.

CODE:

04-1957

ARTWORKER:

CUSTOMER: Waymade
PRODUCT: Motilium 1mg/ml oral suspension

PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

Stop taking Motilium Oral 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 Oral 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 Oral 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)

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 Oral Suspension
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not take Motilium Oral Suspension 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.
If the suspension becomes discoloured or shows signs of any deterioration, you should consult your pharmacist who will
advise you what to do.

6. Contents of the pack and other information
What Motilium Oral Suspension contains
Each ml of oral suspension contains 1mg of Domperidone.
The other ingredients are sorbitol (E420), microcrystalline cellulose (E460), carmellose sodium (E466), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin (E954), polysorbate 20 (E432), sodium hydroxide and
purified water.
What Motilium Oral Suspension looks like and contents of the pack
Each pack contains a 200 millilitre white plastic bottle of a white coloured, oral suspension with a 20ml/4ml measuring cup.
Product Licence holder and manufacturer:
POM

PL No: 06464/2814

This product is manufactured by Laboratorios Dr. Esteve S.A., C/Sant Marti, s/n. Pol. Industrial La Roca, 08107 Martorelles,
Barcelona, Spain and is procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex. SS14 3FR
Leaflet revision date (Ref) 18.09.2014

WARNING!

Taking this medicine
• Take this medicine by mouth.
• Adults and adolescents: take your medicine using the plastic measuring cup provided with Motilium Oral
Suspension. This cup is marked in ml (millilitres) to help you measure out the correct amount of this medicine.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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 Oral Suspension for longer than 7 days
without consulting your doctor.

WARNING!

27mm

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

3. How to take Motilium Oral 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.

27mm




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.
• 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.

1. What Domperidone Oral Suspension is and what it is used for
The name of your medicine is Domperidone 1mg/ml Oral Suspension (called Domperidone Oral Suspension in this leaflet). The
active ingredient in this medicine is called domperidone. This belongs to a group of medicines called ‘dopamine antagonists’.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 180 x 429

In this leaflet:
1. What Domperidone Oral Suspension is and what it is used for
2. What you need to know before you take Domperidone Oral Suspension
3. How to take Domperidone Oral Suspension
4. Possible side effects
5. How to store Domperidone Oral Suspension
6. Contents of the pack and other information

Domperidone Oral 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).

PROOF HISTORY:
v.3 - waymade - 18/09/14

2. What you need to know before you take Domperidone Oral Suspension
Do not take Domperidone Oral Suspension if:
• You are allergic (hypersensitive) to domperidone or any of the other ingredients of Domperidone Oral 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 round 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”)

WARNING!

DOMPERIDONE 1mg/ml Oral Suspension
Patient Information Leaflet

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000F

Domperidone Oral 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
Oral 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 Oral
Suspension).

DATE:

While taking Domperidone Oral 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.

18/09/14

Other medicines and Domperidone Oral 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 Oral Suspension can affect the way some
other medicines work. Also, some medicines can affect the way Domperidone Oral Suspension works.

UK PIL DATED SEPTEMBER 2014
REPORTING OF SIDE EFFECTS

CODE:

06464/2814F

DATE OF PROOF:

DT
Domperidone 1mg/ml oral suspension

ARTWORKER:
PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

04-1957

Q.A.
APPROVED:

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

Do not take Domperidone Oral Suspension if you are taking medicine to treat:
• Fungal infections such as azole anti-fungals, specifically oral ketoconazole, fluconazole or voriconazole.
• Bacterial infections, specifically erythromycin, clarithromycin, telithromycin, moxifloxacin, pentamidine (these are
antibiotics)
• Heart problems or high blood pressure (e.g., amiodarone, dronedarone, quinidine, disopyramide, dofetilide, sotalol,
diltiazem, verapamil)
• Psychoses (e.g., haloperidol, pimozide, sertindole)
• Depression (e.g., citalopram, escitalopram)
• Gastro-intestinal disorders (e.g., cisapride, dolasetron, prucalopride)
• Allergy (e.g., mequitazine, mizolastine)
• Malaria (in particular halofantrine)
• AIDS/HIV (protease inhibitors)
• 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 Oral Suspension but they should not be taken at the same time
as they may affect how well Domperidone Oral Suspension works. Medicines that reduce stomach acid should be taken after a
meal.
It is important to ask your doctor or pharmacist if Domperidone Oral Suspension is safe for you when you are taking any other
medicines, including medicines obtained without prescription.
Taking Domperidone Oral Suspension with food and drink
It is recommended to take Domperidone Oral 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 Oral 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 Oral Suspension if you are breast-feeding.
Small amounts of domperidone have been detected in breast-milk. Domperidone Oral Suspension may cause unwanted side
effects affecting the heart in a breast-fed baby. Domperidone Oral 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:
Domperidone Oral Suspension does not affect your ability to drive or use machines.
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 Oral Suspension.
This medicine also contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216). These substances may cause
allergic reactions (possibly delayed), and exceptionally, bronchospasm.

WARNING!

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Warnings and precautions
Before taking this medicine contact your doctor if:
• You suffer from liver problems (liver function impairment or failure) (see “Do not take Domperidone Oral Suspension if”)
• 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.

DATE:

CUSTOMER
APPROVED:

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




Children weighing under 35kg: should be given Domperidone Oral 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.

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

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 180 x 429



PROOF HISTORY:
v.3 - waymade - 18/09/14

If you take more Domperidone Oral Suspension than you should:
• If you have used or taken too much Domperidone Oral 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 Domperidone Oral Suspension:
• If you forget to take Domperidone Oral 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, Domperidone Oral Suspension can have side effects, although not everybody gets them.

DATE:

Other side effects include:
Common (affects less than 1 in 10 people)
• Dry mouth
Uncommon (affects less than 1 in 100 people)
• 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

18/09/14
DATE OF PROOF:

Some patients who have used Domperidone Oral 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.

UK PIL DATED SEPTEMBER 2014
REPORTING OF SIDE EFFECTS

Side effects such as feeling drowsy, nervous, agitated or irritable or having a fit are more likely to happen in children.

06464/2814F

DT

DATE:

Not known (Frequency cannot be estimated from the available data)
• 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 Oral 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 Oral 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.

CODE:

04-1957

ARTWORKER:

CUSTOMER: Waymade
PRODUCT: Domperidone 1mg/ml oral suspension

PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

Stop taking Domperidone Oral 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 Oral 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 Oral 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)

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 Oral Suspension
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not take Domperidone Oral Suspension 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.
If the suspension becomes discoloured or shows signs of any deterioration, you should consult your pharmacist who will
advise you what to do.

6. Contents of the pack and other information
What Domperidone Oral Suspension contains
Each ml of oral suspension contains 1mg of domperidone.
The other ingredients are sorbitol (E420), microcrystalline cellulose (E460), carmellose sodium (E466), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin (E954), polysorbate 20 (E432), sodium hydroxide and
purified water.
What Domperidone Oral Suspension looks like and contents of the pack
Each pack contains a 200 millilitre white plastic bottle of a white coloured, oral suspension with a 20ml/4ml measuring cup.
Product Licence holder and manufacturer:
POM

PL No: 06464/2814

This product is manufactured by Laboratorios Dr. Esteve S.A., C/Sant Marti, s/n. Pol. Industrial La Roca, 08107 Martorelles,
Barcelona, Spain and is procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex. SS14 3FR
Leaflet revision date (Ref) 18.09.2014

WARNING!

Taking this medicine
• Take this medicine by mouth.
• Adults and adolescents: 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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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 Oral Suspension for longer than 7 days
without consulting your doctor.

WARNING!

27mm

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

3. How to take Domperidone Oral 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.

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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