Domperidone 10mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Domperidone lOmg 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, 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 domperidone as the active ingredient, which belongs to a group of medicines called 'dopamine antagonists'.
Domperidone works by helping to move food faster through your food pipe (oesophagus), stomach and gut. This is so that it does not stay in the same place for too long. It also helps stop food flowing the wrong way back up your food pipe. 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 in the tablets. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
* 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
* have a blockage or tear in your intestines
* have a tumour of the pituitary gland called a prolactinoma.
* have a moderate or severe liver disease
* your ECG (electrocardiogram) shows a heart problem called "prolonged QT corrected interval"
* have or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure).
* have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood.
* are taking certain medicines (see "Other medicines and Domperidone tablets")
Do not take domperidone tablets 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
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")
* 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.
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 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.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Domperidone. Do this even if they have applied in the past.
Children & adolescents:
Do not give Domperidone tablets to children who weigh less than 35kg.
Other medicines and Domperidone tablets
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 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 and drink: The tablets should be taken before meals. 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.
Breast feeding; 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: Domperidone does not affect your ability to drive or use machines.
Domperidone Tablets contains lactose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE DOMPERIDONE TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
For oral use only.
The tablets must be swallowed with a glass of water.
121XXXX-V1
®
Take the tablets 15 to 30 minutes before meals and, if needed, before you go to bed. Do not crush or chew them.
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.
Adults and adolescents 12 years of aae and older with a body weight of 35 kg or more
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
Domperidone 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. Always take any tablets left over with you, this leaflet and also the box, as this will allow easier identification of the tablets. The signs of taking more than you should include feeling sleepy, confused, uncontrolled movements (especially in children) which include unusual eye movements, unusual movements of the tongue or abnormal posture (such as a twisted neck).
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 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Domperidone tablets can have side effects, although not everybody
gets them.
Stop taking Domperidone tablets 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 tablets.
* 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 tablets.
* Have a very fast or unusual heartbeat. This could be a sign of a life- threatening heart problem.
* Have a fit (seizure)
Other side effects include:
Common (affects less than 1 in 10 people)
• Dry mouth
Uncommon (affects less than 1 in 1,00 people)
* Feeling anxious * Lowering of sexual drive (libido) in men
* Feeling drowsy * Itchy skin. You may also have a rash
* Headaches * Painful or tender breasts
* Diarrhoea * A general feeling of weakness
* Unusual production of breast milk in men and women
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 tablets 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 tablets 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 tablets 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 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. 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 sight and reach of children
Do not store above 25°C. Store in the original package.
Do not use the tablets after the expiry date stated on the label.
If the tablets become discoloured or show signs of deterioration, you should seek the advice of your pharmacist.
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 Tablets contains
The active substance is domperidone maleate, equivalent to 10 mg domperidone. The other ingredients are microcrystalline cellulose, lactose monohydrate, maize starch, povidone K30, sodium lauryl sulphate, silica colloidal anhydrous, magnesium stearate
What Domperidone Tablets looks like and contents of the pack
The tablets are white, round, biconvex and uncoated with "Dm 10" marked on one side. They are available in blister packs of 30 and 100 tablets. Not all pack sizes may be marketed
This leaflet was last revised in March 2016
POM
PL 44041/0011
Marketing Authorization Holder:
Jm NOUMED LIFE SCIENCES
5 Cattle Market, Hexham, Northumberland NE46 1NJ, United Kingdom
Manufacturer: MEDREICH PLC
Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail : info@medreich.co.uk
121XXXX-V1