Domperidone 10mg Tablets
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Domperidone Tablets
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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 because it contains important information for you.
- Keep this leaflet. You may need to read it again
- If you have any further questions, ask your doctor or pharmacist
- This medicine has been prescribed for you only. 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 or pharmacist. This includes any possible side effects not listed in this leaflet see section 4.
What is in this leaflet:
1. What Domperidone Tablets are and what they are used for
2. What you need to know before you take Domperidone Tablets
3. How to take Domperidone Tablets
4. Possible side effects
5. How to store Domperidone Tablets
6. Contents of the pack and other information_
_1. What Domperidone Tablets are and what they are used for_
Domperidone Tablets contain active ingredient called Domperidone and belongs to a class of medicine called anti-emetics.
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 Tablets
Do not take Domperidone Tablets if:
• you are allergic (hypersensitive) to domperidone or any of the other ingredients of this medicine (listed under section 6).
• you have a moderate or severe liver disease
• your ECG (electrocardiogram) shows a heart problem called "prolonged QT corrected 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 Tablets")
• you have a tumour of the pituitary gland (prolactinoma)
• 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.
Warnings and Precautions:
Before taking this medicine contact your doctor if you:
- suffer from liver problems (liver function impairment or failure) (see "Do not take Domperidone Tablets if”)
- 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 domperidone less often, and your doctor may want to examine you regularly.
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 Domperidone 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 Domperidone tablets
Do not take Domperidone 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)
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 is safe for you when you are taking any other medicines, including medicines obtained without prescription.
Domperidone Tablets with food, drink and alcohol
It is recommended to take domperidone tablets before meals, as when taken after meals the absorption of the medicine is slightly delayed
Pregnancy, breast-feeding and fertility
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
At normal doses, this medicine does not affect your ability to drive or use machines.
If you notice symptoms of drowsiness, disorientation and lack of co-ordination do not drive or use machines.
Domperidone Tablets contain lactose
• If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
_3. How to take Domperidone Tablets_
Follow these instructions closely unless your doctor has advised you otherwise.
Duration of treatment:
Symptoms usually resolve with 3-4 days of taking this medicine. Do not take domperidone for longer than 7 days without consulting your doctor.
Taking this medicine
• Swallow the tablets whole with a drink of water
• Take the tablets 15 to 30 minutes before a meal
• Do not crush or chew them
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Adults and adolescents 12 years of age and older with a body weight of 35 kg or more
Tablets 10 mg -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
Tablets are not suitable for children weighing less than 35 kg. If domperidone is for a child, ask your doctor for the children's formulation.
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 tablets than you should
If you have used or taken too much Domperidone, contact your doctor, pharmacist or the poison centre immediately, in particular if a child has taken too much. 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.
Symptoms of overdose are: sleepiness, confusion, uncontrolled movements (especially in children) which include unusual eye movements, unusual movements of the tongue or abnormal posture (such as a twisted neck).
If you forget to take Domperidone Tablets
Take your medicine as soon as you remember. If it is almost time for your 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.
_4. Possible side effects_
Like all medicines, these tablets can cause side effects, although not everybody gets them.
• 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. This is more likely to happen in children. 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 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 children.
• Feeling agitated or irritable
• Feeling more nervous than usual
• Abnormal eye movements
• 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 Domperidone 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.
Side effects such as feeling drowsy, nervous, agitated or irritable or having a fit are more likely to happen in children.
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 Tablets
• Keep out of the sight and reach of children.
• Do not store above 250C. Store it in the original package
• Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• 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 to protect the environment.
6. Contents of the pack and other information
What Domperidone 10mg Tablets contain
Each tablet contains 12.72 mg of Domperidone maleate as the active ingredient which is equivalent to 10mg of Domperidone.
Other ingredients in the tablet are: Lactose monohydrate, maize starch, microcrystalline cellulose, polyvidone, sodium lauryl sulphate, magnesium stearate, silica colloidal anhydrous.
What Domperidone Tablets look like and contents of the pack
Domperidone 10mg Tablets are white, round, biconvex tablets embossed on one side with ”Dm 10". They are available in pack sizes of 10 or 20 tablets. Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canal side, Northbridge Road,
Berkhamsted, Hertfordshire,
United Kingdom, HP4 1EG Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
E-mail: info@bristol-labs.co.uk
Domperidone 10mg Tablets; PL 17907/0322
This leaflet was last revised in February 2015.
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V12 20-02-15 DO
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400 mm
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400 x 140 mm
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