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DOMPERIDONE 10MG FILM-COATED TABLETS

Active substance: DOMPERIDONE MALEATE

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(26.25cms)

Neutral code not required on the leaflet artworks.
1st fold

PACKAGE LEAFLET: INFORMATION FOR THE USER
Domperidone 10mg Film-Coated Tablets
Domperidone maleate

8th fold

(26.25cms)

7th fold

(26.25cms)

6th fold

(26.25cms)

5th fold

(26.25cms)

4th fold

(26.25cms)

3rd fold

(26.25cms)

2nd fold

(26.25cms)

▼ 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 while you are receiving your treatment.
− If you have any further questions, please ask your doctor or nurse.
− This medicine has been prescribed for you. Do not pass it onto 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.

In this leaflet:
1. What Domperidone 10mg Film-Coated Tablets are and
what they are used for
2. What you need to know before you take Domperidone
10mg Film-Coated Tablets
3. How to take Domperidone 10mg Film-Coated Tablets
4. Possible side effects
5. How to store Domperidone 10mg Film-Coated Tablets
6. Further information

1. What Domperidone 10mg Film-Coated Tablets are and
what are they used for
The name of your medicine is Domperidone 10mg
Film-Coated Tablets. Domperidone is an anti-emetic which
can stop you feeling sick. The active ingredient is
domperidone maleate.
Each tablet contains 10mg domperidone as domperidone
maleate.
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
10mg Film-Coated Tablets
Important information about some of the ingredients in
your medicine
• If you have been told by your doctor that you have an
intolerance to some sugars, check with your doctor before
taking Domperidone 10mg Film-Coated Tablets.
• This medicinal product contains 0.97 mmol (0.042 mg) of
sodium per tablet. To be taken into consideration by
patients on a controlled sodium dose.
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.
Do not take Domperidone 10mg Tablets if you
• have ever had an allergic reaction to domperidone or any
of the other ingredients listed in section 6, Further
Information
• have or think you may have a serious intestinal problem
such as internal bleeding (symptom being persistent black
bowel motions), or an obstruction or perforation of the
stomach or intestine (usually this involves severe stomach
cramps)
• suffer from a tumour of the pituitary gland called prolactinoma
• if you have a moderate or severe liver disease
• if you ECG (electrocardiogram) shows a heart problem
called “prolonged QT corrected interval”
• if 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)
• if you have a problem that gives you a low level of
potassium or magnesium, or a high level of potassium in
your blood.
• If you are taking certain medicines (see “Taking other
medicines”)
Domperidone 10mg Film-Coated Tablets should not be given
to children weighing less than 35kg.

Warnings and precautions
Before taking this medicine contact your doctor 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 your regularly
• are pregnant, or likely to become pregnant
• are breast-feeding
• suffer from liver problems (liver function impairment or
failure) (see “Do not take this medicinal product”)
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. The risk also increases when
domperidone 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 section other medicines
and Domeperidone 10mg Film-Coated Tablets).
Domperidone should be used at the lowest effective dose in
adults and children.
While taking domperidone, contact your doctor if you
experience heart rhythm disorders such as palpitations,
trouble breathing, loss of consciousness. Treatment with
domperidone should be stopped.
Other medicines and Domeperidone 10mg Film-Coated
Tablets
Do not take Domperidone 10mg Film-Coated Tablets 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)
• opiods, used to treat pain or as an analgesic
• ritonavir, used to treat virus infections.
Tell your doctor or pharmacist if you are taking drugs to treat
infection, heart problems or AIDS/HIV.
It is important to ask your doctor or pharmacist if
Domperidone 100mg Film-Coated Tablets are safe for you
when you are taking any other medicines, including
medicines obtained without prescription.
Breast-feeding
Small amounts of domperidone have been detected in
breast milk. Domperidone may cause unwanted side effects
affecting the heart in a breast-fed baby. Domperidone should
be used during breast feeding only if your physician
considers this clearly necessary. Ask your doctor for
advice before taking this medicine.

104110/3

pg 1/2
ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
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FILE NAME :
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ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :

Process
Black

Domperidone Maleate 10mg - 30 & 100 Tabs
Wockhardt UK
FP2014; FP2016
L1
(w)148 x (h)210mm
2241
214530
7 pt.
Domperidone_Leaflet_104110-3.ai
Adobe Illustrator CS5
Helvetica Medium / Bold
18th & 21st October, 2011
R 1st PDF sent on
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- 25TH OCT. 2011
- 23RD NOV. 2011
- 29TH NOV. 2011
- 27TH JAN. 2012
- 4TH MARCH 2013
- 14TH MARCH 2013
- 14TH MARCH 2013
- 20TH MARCH 2013
- 15TH APRIL 2013
- 19TH APRIL 2013
- 6TH NOV. 2014
- 10TH NOV. 2014
- 11TH NOV. 2014

CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Regulatory text amends
• Pharmacode placed on 8mm from the cutting edge
• Arrow indicating direction of pharmacode reading
• Removed pre-printed neutral code

Product name

Domperidone 10mg Film-Coated Tablets

1st fold

(26.25cms)

2nd fold

(26.25cms)

3rd fold

(26.25cms)

4th fold

(26.25cms)

5th fold

(26.25cms)

6th fold

(26.25cms)

7th fold

6. Further Information
Domperidone 10mg Film-Coated tablets are white, circular,
film coated tablets marked DM on one face, 10 on the
reverse. The active ingredient is domperidone maleate.
Other ingredients in your tablets are lactose, pregelatinised
maize starch, microcrystalline cellulose, sodium starch
glycollate, magnesium stearate and Opadry white
OY-S-28899 which consists of hypromellose, titanium
dioxide (E171) and macrogol.
Domperidone 10mg Tablets are available in cartons of 30 or
100 tablets.
Marketing Authorisation Holder: Wockhardt UK Limited,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited,
Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following information:

(26.25cms)

4. Possible side effects
Like all medicines, Domperidone 10mg Film-Coated Tablets
can have side effects.
Very rarely patients have experienced allergic reactions to
Domperidone.
If any of the following reactions occur, STOP taking your
Domperidone 10mg Film-Coated Tablets and either tell your
doctor immediately or go to your nearest hospital:
• Palpitations or dizziness or changes to heart traces (ECG)
indicating a heart problem
• Facial or neck swelling, flushing or fainting
• Problems with breathing including shortness of breath and
wheezing
• Rash and itching (hives) or nettle rash (urticaria)
• Other allergic reactions such as anaphylactic reaction and
shock
• Uncontrolled movements of the limbs and face, including
the eyes (twitching)
• In exceptional cases mild stomach cramps can occur, but
these should go away quickly.
Other side effects include:
Uncommon (affects less than 1 in 100 people)
• Breast pain
Rare (affects less than 1 in 1,000 people)
• Unusual production of breast milk in men and women
• Disruption of menstrual flow
• Breast growth in men
Very rare (affects less than 1 in 10,000 people)
• Agitation
• Nervousness
• Convulsions (fits)
• Drowsiness
• Headache
• Diarrhoea

5. How to store Domperidone 10mg Film-Coated Tablets
• Keep out of the sight and reach of children.
• Do not use your Domperidone 10mg Tablets after the
expiry date printed on the package.
• If you have any tablets that are out of date, please return
them to your pharmacist for disposal.
• Do not store above 25°C. Store the tablets in the original
package. Do not transfer Domperidone 10mg Film-Coated
tablets to another container.

Reference number
29831/0076

This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in October 2014
104110/3
214530

pg 2/2

8th fold

3. How to take Domperidone 10mg Film-Coated Tablets
These tablets have been prescribed for you by a doctor.
Follow these instructions closely unless your doctor has
advised you otherwise. The tablets should be swallowed whole
with a sufficient quantity of liquid (e.g. one glass of water).
Duration of treatment:
Symptoms usually resolve with 3-4 days of taking this
medicine. Do not take Domperidone 10mg Film-Coated
Tablets for longer than 7 days without consulting your doctor.
Adults and adolescents 12 years of age and older with a
body weight of 35kg or more
The usual dose is one tablet taken up to three times per day,
if possible before meals.
Do not take more than three tablets per day.
Children and adolescents from birth to a body weight of
less than 35 kg
Domperidone 10mg Film-Coated Tablets are not suitable for
children weighing less than 35kg.
If Domperidone 10mg Film-Coated Tablets is for a child, ask
your doctor for the children’s formulation.
If you take more Domperidone 10mg Tablets than you
should
If you have used or taken too much Domperidone 10mg
Film-Coated Tablets, contact your doctor, pharmacist or the
poison centre immediately, in particular if a child has taken
too much. Take this leaflet and any tablets you have left to
show the doctor or pharmacist. 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.
If you forget to take your tablets
Take your tablets as soon as you remember. If it is almost
time for your next dose, wait until that is due and continue as
normal. Do not take a double dose to make up for the
forgotten dose.

• Abnormal liver function test
Not known (cannot be estimated from available data)
• reduced libido
• abnormal movements (muscle spasms causing twisting or
repetitive movements)
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 may be
associated with an
increased risk of heart
rhythm disorder and
cardiac arrest. This risk
may be more likely in
those over 60 years old
or taking doses higher
than 30 mg per day.
Domperidone should be
used at the lowest effective dose in adults and children.
Side effects more likely to occur in children include
convulsions (fits) agitation and drowsiness.
Stop taking Domperidone 10mg Tablets and tell your doctor
as soon as possible if you experience any of the above very
rare side effects.
If you notice any side effects not mentioned in this leaflet, or
if you suffer from any of the side effects listed please inform
your doctor or pharmacist.
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.

(26.25cms)

Driving and using machinery
You may have less control over your movements whilst
taking Domperidone Tablets. If this happens do not drive or
use any tools or machines.
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or
have recently taken any other medicine, even those not
prescribed by a doctor.
If you have any doubts about whether you should take this
medicine then talk to your doctor.

(26.25cms)

Neutral code not required on the leaflet artworks.
1st fold

PACKAGE LEAFLET: INFORMATION FOR THE USER
Domperidone 10mg Film-Coated Tablets
Domperidone maleate

8th fold

(26.25cms)

7th fold

(26.25cms)

6th fold

(26.25cms)

5th fold

(26.25cms)

4th fold

(26.25cms)

3rd fold

(26.25cms)

2nd fold

(26.25cms)

▼ 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 while you are receiving your treatment.
− If you have any further questions, please ask your doctor or nurse.
− This medicine has been prescribed for you. Do not pass it onto 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.

In this leaflet:
1. What Domperidone 10mg Film-Coated Tablets are and
what they are used for
2. What you need to know before you take Domperidone
10mg Film-Coated Tablets
3. How to take Domperidone 10mg Film-Coated Tablets
4. Possible side effects
5. How to store Domperidone 10mg Film-Coated Tablets
6. Further information

1. What Domperidone 10mg Film-Coated Tablets are and
what are they used for
The name of your medicine is Domperidone 10mg
Film-Coated Tablets. Domperidone is an anti-emetic which
can stop you feeling sick. The active ingredient is
domperidone maleate.
Each tablet contains 10mg domperidone as domperidone
maleate.
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
10mg Film-Coated Tablets
Important information about some of the ingredients in
your medicine
• If you have been told by your doctor that you have an
intolerance to some sugars, check with your doctor before
taking Domperidone 10mg Film-Coated Tablets.
• This medicinal product contains 0.97 mmol (0.042 mg) of
sodium per tablet. To be taken into consideration by
patients on a controlled sodium dose.
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.
Do not take Domperidone 10mg Tablets if you
• have ever had an allergic reaction to domperidone or any
of the other ingredients listed in section 6, Further
Information
• have or think you may have a serious intestinal problem
such as internal bleeding (symptom being persistent black
bowel motions), or an obstruction or perforation of the
stomach or intestine (usually this involves severe stomach
cramps)
• suffer from a tumour of the pituitary gland called prolactinoma
• if you have a moderate or severe liver disease
• if you ECG (electrocardiogram) shows a heart problem
called “prolonged QT corrected interval”
• if 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)
• if you have a problem that gives you a low level of
potassium or magnesium, or a high level of potassium in
your blood.
• If you are taking certain medicines (see “Taking other
medicines”)
Domperidone 10mg Film-Coated Tablets should not be given
to children weighing less than 35kg.

Warnings and precautions
Before taking this medicine contact your doctor 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 your regularly
• are pregnant, or likely to become pregnant
• are breast-feeding
• suffer from liver problems (liver function impairment or
failure) (see “Do not take this medicinal product”)
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. The risk also increases when
domperidone 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 section other medicines
and Domeperidone 10mg Film-Coated Tablets).
Domperidone should be used at the lowest effective dose in
adults and children.
While taking domperidone, contact your doctor if you
experience heart rhythm disorders such as palpitations,
trouble breathing, loss of consciousness. Treatment with
domperidone should be stopped.
Other medicines and Domeperidone 10mg Film-Coated
Tablets
Do not take Domperidone 10mg Film-Coated Tablets 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)
• opiods, used to treat pain or as an analgesic
• ritonavir, used to treat virus infections.
Tell your doctor or pharmacist if you are taking drugs to treat
infection, heart problems or AIDS/HIV.
It is important to ask your doctor or pharmacist if
Domperidone 100mg Film-Coated Tablets are safe for you
when you are taking any other medicines, including
medicines obtained without prescription.
Breast-feeding
Small amounts of domperidone have been detected in
breast milk. Domperidone may cause unwanted side effects
affecting the heart in a breast-fed baby. Domperidone should
be used during breast feeding only if your physician
considers this clearly necessary. Ask your doctor for
advice before taking this medicine.

106016/3

pg 1/2
ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Process
Black

Domperidone Maleate 10mg - 30 & 100 Tabs
Wockhardt UK
FP2014; FP2016
Daman (Bhimpore)
(w)148 x (h)210mm
2466
220486
7 pt.
Domperidone_Leaflet_106016-3.ai
Adobe Illustrator CS5
Helvetica Medium / Bold
3rd & 6th November, 2014
R 1st PDF sent on - 6TH NOV. 2014
R 2nd PDF sent on - 10TH NOV. 2014
R 3rd PDF sent on - 11TH NOV. 2014

CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Regulatory text amends
• Pharmacode placed on 8mm from the cutting edge

Product name

Domperidone 10mg Film-Coated Tablets

1st fold

(26.25cms)

2nd fold

(26.25cms)

3rd fold

(26.25cms)

4th fold

(26.25cms)

5th fold

(26.25cms)

6th fold

(26.25cms)

7th fold

6. Further Information
Domperidone 10mg Film-Coated tablets are white, circular,
film coated tablets marked DM on one face, 10 on the
reverse. The active ingredient is domperidone maleate.
Other ingredients in your tablets are lactose, pregelatinised
maize starch, microcrystalline cellulose, sodium starch
glycollate, magnesium stearate and Opadry white
OY-S-28899 which consists of hypromellose, titanium
dioxide (E171) and macrogol.
Domperidone 10mg Tablets are available in cartons of 30 or
100 tablets.
Marketing Authorisation Holder: Wockhardt UK Limited,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited,
Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following information:

(26.25cms)

4. Possible side effects
Like all medicines, Domperidone 10mg Film-Coated Tablets
can have side effects.
Very rarely patients have experienced allergic reactions to
Domperidone.
If any of the following reactions occur, STOP taking your
Domperidone 10mg Film-Coated Tablets and either tell your
doctor immediately or go to your nearest hospital:
• Palpitations or dizziness or changes to heart traces (ECG)
indicating a heart problem
• Facial or neck swelling, flushing or fainting
• Problems with breathing including shortness of breath and
wheezing
• Rash and itching (hives) or nettle rash (urticaria)
• Other allergic reactions such as anaphylactic reaction and
shock
• Uncontrolled movements of the limbs and face, including
the eyes (twitching)
• In exceptional cases mild stomach cramps can occur, but
these should go away quickly.
Other side effects include:
Uncommon (affects less than 1 in 100 people)
• Breast pain
Rare (affects less than 1 in 1,000 people)
• Unusual production of breast milk in men and women
• Disruption of menstrual flow
• Breast growth in men
Very rare (affects less than 1 in 10,000 people)
• Agitation
• Nervousness
• Convulsions (fits)
• Drowsiness
• Headache
• Diarrhoea

5. How to store Domperidone 10mg Film-Coated Tablets
• Keep out of the sight and reach of children.
• Do not use your Domperidone 10mg Tablets after the
expiry date printed on the package.
• If you have any tablets that are out of date, please return
them to your pharmacist for disposal.
• Do not store above 25°C. Store the tablets in the original
package. Do not transfer Domperidone 10mg Film-Coated
tablets to another container.

Reference number
29831/0076

This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in October 2014
106016/3
220486

pg 2/2

8th fold

3. How to take Domperidone 10mg Film-Coated Tablets
These tablets have been prescribed for you by a doctor.
Follow these instructions closely unless your doctor has
advised you otherwise. The tablets should be swallowed whole
with a sufficient quantity of liquid (e.g. one glass of water).
Duration of treatment:
Symptoms usually resolve with 3-4 days of taking this
medicine. Do not take Domperidone 10mg Film-Coated
Tablets for longer than 7 days without consulting your doctor.
Adults and adolescents 12 years of age and older with a
body weight of 35kg or more
The usual dose is one tablet taken up to three times per day,
if possible before meals.
Do not take more than three tablets per day.
Children and adolescents from birth to a body weight of
less than 35 kg
Domperidone 10mg Film-Coated Tablets are not suitable for
children weighing less than 35kg.
If Domperidone 10mg Film-Coated Tablets is for a child, ask
your doctor for the children’s formulation.
If you take more Domperidone 10mg Tablets than you
should
If you have used or taken too much Domperidone 10mg
Film-Coated Tablets, contact your doctor, pharmacist or the
poison centre immediately, in particular if a child has taken
too much. Take this leaflet and any tablets you have left to
show the doctor or pharmacist. 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.
If you forget to take your tablets
Take your tablets as soon as you remember. If it is almost
time for your next dose, wait until that is due and continue as
normal. Do not take a double dose to make up for the
forgotten dose.

• Abnormal liver function test
Not known (cannot be estimated from available data)
• reduced libido
• abnormal movements (muscle spasms causing twisting or
repetitive movements)
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 may be
associated with an
increased risk of heart
rhythm disorder and
cardiac arrest. This risk
may be more likely in
those over 60 years old
or taking doses higher
than 30 mg per day.
Domperidone should be
used at the lowest effective dose in adults and children.
Side effects more likely to occur in children include
convulsions (fits) agitation and drowsiness.
Stop taking Domperidone 10mg Tablets and tell your doctor
as soon as possible if you experience any of the above very
rare side effects.
If you notice any side effects not mentioned in this leaflet, or
if you suffer from any of the side effects listed please inform
your doctor or pharmacist.
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.

(26.25cms)

Driving and using machinery
You may have less control over your movements whilst
taking Domperidone Tablets. If this happens do not drive or
use any tools or machines.
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or
have recently taken any other medicine, even those not
prescribed by a doctor.
If you have any doubts about whether you should take this
medicine then talk to your doctor.

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UK Version Artwork

In this leaflet:
1. What Domperidone 10mg Film-Coated Tablets are and
what they are used for
2. What you need to know before you take Domperidone
10mg Film-Coated Tablets
3. How to take Domperidone 10mg Film-Coated Tablets
4. Possible side effects
5. How to store Domperidone 10mg Film-Coated Tablets
6. Further information

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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 while you are receiving your treatment.
− If you have any further questions, please ask your doctor or nurse.
− This medicine has been prescribed for you. Do not pass it onto 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.

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Domperidone 10mg Film-Coated Tablets
Domperidone maleate

1. What Domperidone 10mg Film-Coated Tablets are and
what are they used for
The name of your medicine is Domperidone 10mg
Film-Coated Tablets. Domperidone is an anti-emetic which
can stop you feeling sick. The active ingredient is
domperidone maleate.
Each tablet contains 10mg domperidone as domperidone
maleate.
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
10mg Film-Coated Tablets
Important information about some of the ingredients in
your medicine
• If you have been told by your doctor that you have an
intolerance to some sugars, check with your doctor before
taking Domperidone 10mg Film-Coated Tablets.
• This medicinal product contains 0.97 mmol (0.042 mg) of
sodium per tablet. To be taken into consideration by
patients on a controlled sodium dose.
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.
Do not take Domperidone 10mg Tablets if you
• have ever had an allergic reaction to domperidone or any
of the other ingredients listed in section 6, Further
Information
• have or think you may have a serious intestinal problem
such as internal bleeding (symptom being persistent black
bowel motions), or an obstruction or perforation of the
stomach or intestine (usually this involves severe stomach
cramps)
• suffer from a tumour of the pituitary gland called prolactinoma
• if you have a moderate or severe liver disease
• if you ECG (electrocardiogram) shows a heart problem
called “prolonged QT corrected interval”
• if 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)
• if you have a problem that gives you a low level of
potassium or magnesium, or a high level of potassium in
your blood.
• If you are taking certain medicines (see “Taking other
medicines”)
Domperidone 10mg Film-Coated Tablets should not be given
to children weighing less than 35kg.

Warnings and precautions
Before taking this medicine contact your doctor 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 your regularly
• are pregnant, or likely to become pregnant
• are breast-feeding
• suffer from liver problems (liver function impairment or
failure) (see “Do not take this medicinal product”)
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. The risk also increases when
domperidone 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 section other medicines
and Domeperidone 10mg Film-Coated Tablets).
Domperidone should be used at the lowest effective dose in
adults and children.
While taking domperidone, contact your doctor if you
experience heart rhythm disorders such as palpitations,
trouble breathing, loss of consciousness. Treatment with
domperidone should be stopped.
Other medicines and Domeperidone 10mg Film-Coated
Tablets
Do not take Domperidone 10mg Film-Coated Tablets 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)
• opiods, used to treat pain or as an analgesic
• ritonavir, used to treat virus infections.
Tell your doctor or pharmacist if you are taking drugs to treat
infection, heart problems or AIDS/HIV.
It is important to ask your doctor or pharmacist if
Domperidone 100mg Film-Coated Tablets are safe for you
when you are taking any other medicines, including
medicines obtained without prescription.
Breast-feeding
Small amounts of domperidone have been detected in
breast milk. Domperidone may cause unwanted side effects
affecting the heart in a breast-fed baby. Domperidone should
be used during breast feeding only if your physician
considers this clearly necessary. Ask your doctor for
advice before taking this medicine.

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Domperidone Maleate 10mg - 30 & 100 Tabs
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Reference number
29831/0076

This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in October 2014

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Product name

Domperidone 10mg Film-Coated Tablets

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6. Further Information
Domperidone 10mg Film-Coated tablets are white, circular,
film coated tablets marked DM on one face, 10 on the
reverse. The active ingredient is domperidone maleate.
Other ingredients in your tablets are lactose, pregelatinised
maize starch, microcrystalline cellulose, sodium starch
glycollate, magnesium stearate and Opadry white
OY-S-28899 which consists of hypromellose, titanium
dioxide (E171) and macrogol.
Domperidone 10mg Tablets are available in cartons of 30 or
100 tablets.
Marketing Authorisation Holder: Wockhardt UK Limited,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited,
Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following information:

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4. Possible side effects
Like all medicines, Domperidone 10mg Film-Coated Tablets
can have side effects.
Very rarely patients have experienced allergic reactions to
Domperidone.
If any of the following reactions occur, STOP taking your
Domperidone 10mg Film-Coated Tablets and either tell your
doctor immediately or go to your nearest hospital:
• Palpitations or dizziness or changes to heart traces (ECG)
indicating a heart problem
• Facial or neck swelling, flushing or fainting
• Problems with breathing including shortness of breath and
wheezing
• Rash and itching (hives) or nettle rash (urticaria)
• Other allergic reactions such as anaphylactic reaction and
shock
• Uncontrolled movements of the limbs and face, including
the eyes (twitching)
• In exceptional cases mild stomach cramps can occur, but
these should go away quickly.
Other side effects include:
Uncommon (affects less than 1 in 100 people)
• Breast pain
Rare (affects less than 1 in 1,000 people)
• Unusual production of breast milk in men and women
• Disruption of menstrual flow
• Breast growth in men
Very rare (affects less than 1 in 10,000 people)
• Agitation
• Nervousness
• Convulsions (fits)
• Drowsiness
• Headache
• Diarrhoea

5. How to store Domperidone 10mg Film-Coated Tablets
• Keep out of the sight and reach of children.
• Do not use your Domperidone 10mg Tablets after the
expiry date printed on the package.
• If you have any tablets that are out of date, please return
them to your pharmacist for disposal.
• Do not store above 25°C. Store the tablets in the original
package. Do not transfer Domperidone 10mg Film-Coated
tablets to another container.

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3. How to take Domperidone 10mg Film-Coated Tablets
These tablets have been prescribed for you by a doctor.
Follow these instructions closely unless your doctor has
advised you otherwise. The tablets should be swallowed whole
with a sufficient quantity of liquid (e.g. one glass of water).
Duration of treatment:
Symptoms usually resolve with 3-4 days of taking this
medicine. Do not take Domperidone 10mg Film-Coated
Tablets for longer than 7 days without consulting your doctor.
Adults and adolescents 12 years of age and older with a
body weight of 35kg or more
The usual dose is one tablet taken up to three times per day,
if possible before meals.
Do not take more than three tablets per day.
Children and adolescents from birth to a body weight of
less than 35 kg
Domperidone 10mg Film-Coated Tablets are not suitable for
children weighing less than 35kg.
If Domperidone 10mg Film-Coated Tablets is for a child, ask
your doctor for the children’s formulation.
If you take more Domperidone 10mg Tablets than you
should
If you have used or taken too much Domperidone 10mg
Film-Coated Tablets, contact your doctor, pharmacist or the
poison centre immediately, in particular if a child has taken
too much. Take this leaflet and any tablets you have left to
show the doctor or pharmacist. 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.
If you forget to take your tablets
Take your tablets as soon as you remember. If it is almost
time for your next dose, wait until that is due and continue as
normal. Do not take a double dose to make up for the
forgotten dose.

• Abnormal liver function test
Not known (cannot be estimated from available data)
• reduced libido
• abnormal movements (muscle spasms causing twisting or
repetitive movements)
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 may be associated with an increased risk of
heart rhythm disorder and cardiac arrest. This risk may be
more likely in those over 60 years old or taking doses higher
than 30 mg per day. Domperidone should be used at the
lowest effective dose in adults and children.
Side effects more likely to occur in children include
convulsions (fits) agitation and drowsiness.
Stop taking Domperidone 10mg Tablets and tell your doctor
as soon as possible if you experience any of the above very
rare side effects.
If you notice any side effects not mentioned in this leaflet, or
if you suffer from any of the side effects listed please inform
your doctor or pharmacist.
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.

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Driving and using machinery
You may have less control over your movements whilst
taking Domperidone Tablets. If this happens do not drive or
use any tools or machines.
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or
have recently taken any other medicine, even those not
prescribed by a doctor.
If you have any doubts about whether you should take this
medicine then talk to your doctor.

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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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