Patient leaflet - Domperidone 10 mg Orodisperisible tablets
1. What Domperidone is and what it is used for
The name of your medicine is Domperidone 10 mg Orodispersible Tablets (referred to as Domperidone throughout this leaflet). The active ingredient in this medicine is called domperidone. This belongs to a group of medicines called 'dopamine antagonists'.
This medicine is used to treat nausea (feeling sick) and vomiting (being sick) in adults and adolescents (12 years of age and older weighing 35 kg or more).
2. What you need to know before you take Domperidone
Do not take Domperidone
- if you are allergic (hypersensitive) to domperidone or any of the other ingredients of this medicine (listed in section 6). 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 or may have a rare tumour of the adrenal gland (pheochromocytoma) because it could elevate your blood pressure.
- 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 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 ").
Do not take Domperidone if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
- if you suffer from liver problems (liver function impairment or failure) (see "Do not take domperidone if")
- 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 are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Do this even if they have applied in the past.
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 "Other medicines and Domperidone ").
Domperidone should be used at the lowest effective dose.
While taking this medicine, 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
Domperidone should not be given to adolescents 12 years of age and older weighing less than 35 kg, or in any children less than 12 years of age, as it is not effective in these age groups.
Other medicines and Domperidone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Domperidone 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, AIDS/HIV or Parkinson’s disease.
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 but they should not be taken at the same time as they may affect how well this medicine works. Medicines that reduce stomach acid should be taken after a meal.
Domperidone and apomorphine
Before you use this medicine and apomorphine, your doctor will ensure that you tolerate both medicines when used simultaneously. Ask your doctor or specialist for a personalised advice. Please refer to the apomorphine leaflet.
It is important to ask your doctor or pharmacist if Domperidone Orodispersible Tablets is safe for you when you are taking any other medicines, including medicines obtained without prescription.
Domperidone with food and drink
It is recommended to take this medicine before meals as when taken after meals the absorption of the medicine is slightly delayed.
Pregnancy and breastfeeding
Talk to your doctor or pharmacist before taking this medicine if:
- you are pregnant, might become pregnant or think you may be pregnant
- you are breast-feeding. It is best not to take Domperidone if you are breast-feeding.
Small amounts of Domperidone have been detected in breast-milk. This medicine 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
Domperidone can affect your ability to drive or use machinery as it may make you sleepy. Do not drive while taking this medicine until you know how it affects you.
Domperidone Tablets also contains aspartame
This medicine contains 7.5 mg aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly
3. How to take Domperidone
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or if you are not sure.
Duration of treatment
Your doctor will decide how long you will need to take this medicine.
Symptoms usually resolve within 3-4 days of taking this medicine. Do not take Domperidone Orodispersible Tablets for longer than 7 days without consulting your doctor.
Taking this medicine
Adults and adolescents 12 years of age and older with a body weight of 35 kg or more
The usual dose is one 10 mg tablet taken up to three times per day, if possible before meals. Do not take more than three tablets per day.
Method of administration
Oral route.
The orodispersible tablet disperses rapidly in the mouth in the saliva, and can be taken with or without water. When taken without water, the tablet should be placed on the tongue and allowed to disperse in the mouth before swallowing. You may drink a glass of water after taking the tablet if necessary.
The tablets should be taken before meals. If taken after meals absorption of the drug is somewhat delayed.
This product is not suitable for children under 12 years of age. This product is also not suitable for adolescents 12 years of age and older with a body weight of less than 35 kg.
People with kidney problems
Your doctor may tell you to take a lower dose or to take the medicine less often.
If you take more Domperidone than you should
- if you have used or taken too much Domperidone Orodispersible Tablets, contact your doctor, pharmacist or the poisons unit at your nearest hospital casualty department immediately. Take the carton 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 which include unusual eye movements, unusual movements of the tongue or abnormal posture (such as a twisted neck).
If you forget to take Domperidone
- if you forget to take this medicine, 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.
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.
Stop taking Domperidone 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
- 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. These symptoms should stop once you stop taking Domperidone
- you have a very fast or unusual heartbeat. This could be a sign of a life-threatening heart problem
- you have a fit (seizure).
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 agitated or irritable
- feeling more nervous than usual
- 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
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 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 adolescents 12 years of age and older • abnormal eye movements
- feeling the urge to move your legs, arms or other parts of your body (restless legs syndrome). These symptoms may become worse in patients suffering from Parkinson’s disease.
- 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
Some patients who have used this medicine 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Domperidone
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original pack in order to protect from moisture.
Do not throw away any 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 Orodispersible Tablets contains
The active substance is domperidone. The tablet contains 10 mg of domperidone.
The other ingredients are mannitol (E421), colloidal silicon dioxide, microcrystalline cellulose, aspartame (E 951), crospovidone, peppermint flavour and magnesium stearate.
What Domperidone Orodispersible Tablets looks like and contents of the pack
Orodispersible Tablet
White to off-white, round, flat, bevelled edged tablets, 9 mm diameter, plain on both sides, having peppermint odour.
This medicine is available in blister packs containing 30 orodispersible tablets.
Marketing Authorisation Holder
Regalium Pharma Limited
Flat 2, Quadrate Apartments
104 Pembroke Road, Ruislip,
England, HA4 8FU
Manufacturer
Inpharmasci, ZI N°2 de Prouvy - Rouvignies, 1 rue de Nungesser, 59121 Prouvy, France