Domperidone 10mg Film-Coated Tablets
Package leaflet: Information for the user Domperidone 10mg Film-Coated Tablets
Domperidone maleate
▼ 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 because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
What is 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. Contents of the pack and other 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.
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
Do not take Domperidone 10mg Tablets
• if you are allergic to domperidone or any of the other ingredients of this medicine (listed in section 6)
• if you 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)
• if you suffer from a tumour of the pituitary gland called prolactinoma
• if you have a moderate or severe liver disease
• if your 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 “Other medicines and Domeperidone 10mg Film-Coated Tablets”)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Domperidone 10mg Film-Coated Tablets
• 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
• if you suffer from liver problems (liver function impairment or failure) (see “Do not take Domperidone 10mg Tablets”)
• if you are taking a medicine called levodopa, see 'Other medicines and Domperidone 10mg Film-Coated Tablets'.
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.
Children and adolescents
Do not give Domperidone 10mg Film-Coated Tablets to children who weigh less than 35kg.
If Domperidone 10mg Film-Coated Tablets is for a child, ask your doctor for the children's formulation.
Other medicines and Domeperidone 10mg Film-Coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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)
• opioids, used to treat pain or as an analgesic
• ritonavir, used to treat virus infections.
Tell your doctor or pharmacist if you are taking levodopa (a medicine used to treat the symptoms of Parkinson's disease), drugs to treat infection, heart problems or AIDS/HIV.
It is important to ask your doctor or pharmacist if Domperidone 10mg Film-Coated Tablets are safe for you when you are taking any other medicines, including medicines obtained without prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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.
Driving and using machines
You may have less control over your movements whilst taking Domperidone Tablets. If this happens do not drive or use any tools or machines.
Domperidone 10mg Film-Coated Tablets contain lactose and sodium
• Lactose: 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.
• Sodium: 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.
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. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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 recommended dose is one tablet taken up to three times per day, if possible before meals.
Do not take more than three tablets per day.
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 Domperidone 10mg 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 a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious 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
• 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 10mg Film-Coated Tablets.
• In exceptional cases mild stomach cramps can occur, but these should go away quickly.
Other side effects
Uncommon: may affect up to 1 in 100 people
• Breast pain
Rare: may affect up to 1 in 1,000 people
• Unusual production of breast milk in men and women
• Disruption of menstrual flow
• Breast growth in men
Very rare: may affect up to 1 in 10,000 people
• Agitation
• Nervousness
• Convulsions (fits)
• Drowsiness
• Headache
• Diarrhoea
• Abnormal liver function test
Not known: frequency cannot be estimated from the available data
• reduced libido
• abnormal movements (muscle spasms causing twisting or repetitive movements)
• a worsening of restless leg syndrome in patients with Parkinson's disease.
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.
5. How to store Domperidone 10mg Film-Coated Tablets
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date printed on the package. The expiry date refers to the last day of that month.
• 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.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Domperidone 10mg Tablets contain
The active ingredient is domperidone maleate. Each tablet contains 10mg domperidone as 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.
What Domperidone 10mg Tablets look like and contents of the pack
Domperidone 10mg Film-Coated tablets are white, circular, film coated tablets marked DM on one face, 10 on the reverse.
Domperidone 10mg Tablets are available in cartons of 30 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.
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Product name |
Reference number |
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Domperidone 10mg Film-Coated Tablets |
29831/0076 |
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This leaflet was last revised in 04/2016 104110/5
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