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DOMPERIDONE 10MG FILM-COATED TABLETS

Active substance: DOMPERIDONE MALEATE

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

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. 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 they are 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.
Domperidone is used to treat
• nausea and vomiting
• indigestion or a feeling of discomfort or fullness in the
stomach.
2. 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.

• have liver problems
Domperidone 10mg Film-Coated Tablets should not be
given to children weighing less than 35kg.
Before you use Domperidone 10mg Film-Coated Tablets
tell your doctor if you
• have a kidney disorder.
• are pregnant, or likely to become pregnant.
• are breast-feeding.
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 taken with other medicines the effect of Domperidone
10mg Tablets or the effects of the other medicine may be
altered.
Examples of medicines that can affect domperidone are:
• Opiods, used to treat pain or as an analgesic
• ketonazole, used to treat fungal infections
• ritonavir, used to treat virus infections
• erythromycin, used to treat bacterial infections
If you have any doubts about whether you should take this
medicine then talk to your doctor.
3. How to take Domperidone 10mg Film-Coated Tablets
These tablets have been prescribed for you by a doctor.
Take them exactly as he or she has told you. Please read
the label carefully. The tablets should be swallowed whole
with a sufficient quantity of liquid (e.g. one glass of water).
Adults
The usual dose for nausea and vomiting in adults is
10-20mg (1-2 tablets) three to four times a day.
Children
Children weighing less than 35kg (5½ stone) should not take
these tablets.
The usual dose for the treatment is 0.25 - 0.5mg per kg
bodyweight taken three to four times a day.

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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
 10th PDF sent on - 19TH APRIL 2013

CHANGE CONTROL : Version changes due to change in:
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Non-Regulatory
Changes in detail: • New regulatory text (as requested by WUK)
• Arrow indicating direction of pharmacode reading
• Removed pre-printed neutral code
• Pharmacode positioned at 5mm from the cutting edge

Your pharmacist may be able to help you if you are not sure.
You should not take the tablets for more than four weeks
without consulting your doctor.
The dose should be reduced for patients with severe kidney
problems and reviewed regularly by your doctor.
Your doctor may advise you to take your medicine in a
different way, so you should always follow your doctor's
advice about how and when to take your medicine and
always read the label. If you feel that the effect of
Domperidone 10mg Film-Coated Tablets is too strong or too
weak, talk to your doctor or pharmacist.
If you take more Domperidone 10mg Tablets than you
should
If you accidentally take too many tablets you should contact
your doctor, pharmacist or nearest hospital casualty
department immediately. Take this leaflet and any tablets
you have left to show the doctor or pharmacist
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.
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
• Abnormal liver function test
Not known (cannot be estimated from available data)

• reduced libido
• abnormal movements (muscle spasms causing twisting or
repetitive movements)
Domperidone 10mg Tablets may be associated with an
increased risk of heart rhythm disorder and cardiac arrest.
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.
5. How to store Domperidone 10mg Film-Coated Tablets
• Keep out of the reach and sight 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.
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:
Product name

Domperidone 10mg Film-Coated
Tablets

Reference number
29831/0076

This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in April 2013
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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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