Medication Guide App

BOOTS STOMACH COMFORT 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 antiemetic 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.
• heartburn

2. Before you take Domperidone 10mg Film-Coated Tablets
Important information about some of the ingredients in your medicine
•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.
• 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.
Do not take Domperidone 10mg Tablets if you
• have ever had heart problems including heart failure, a previous heart attack, angina (chest pains),
or heart rhythm disorders including a rapid or slow or irregular heartbeat.
• 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 are not recommended for children under 16 years of age.
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
10mg (1 tablet) up to three times a day and at night.
Children
Not recommended for use in children
You should not take the tablets for more than two 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.
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.
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 reaction 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.
Uncommon Side Effects (affects less than 1 in 100 people)
•Breast pain
Rare Side Effects (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.
-Coated Tablets

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

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
29831/0355

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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