Domperidone 1mg/Ml Oral Suspension
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PATIENT INFORMATION LEAFLET
This medicine is available using the above name but will be referred to as Domperidone throughout this leaflet. This leaflet has been written to help you get the best effect from your medicine.
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to 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.
• Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.
In this leaflet:
1. What domperidone is and what it is used for
2. What you need to know before you take domperidone
3. How to take domperidone
4. Possible side effects
5. How to store domperidone
6. Contents of the pack and other information
1. WHAT DOMPERIDONE IS AND WHAT IT IS USED FORl
The name of your medicine is Domperidone 1mg/ml Oral Suspension (called domperidone in this leaflet). The active ingredient in this medicine is called domperidone. This 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.
Domperidone can be used for the following:
Adults
• To stop or prevent you feeling sick (nausea) or being sick (vomiting).
• To stop or prevent the feeling of fullness during or shortly after a meal.
• To treat stomach discomfort, or heartburn caused by the flow of the stomach contents back into your food pipe.
Children
• To stop or prevent children feeling sick (nausea) or being sick (vomiting).
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 Domperidone 1mg/ml Oral Suspension (listed in section 6: Contents of the pack and other information). 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 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.
• If you have or have had liver problems.
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 domperidone.
Take special care with domperidone and check with your doctor or pharmacist before taking this medicine if:
• You have any kidney problems. If you take domperidone over a long period, your doctor may want to lower the amount you use. This will depend on how severe your kidney problems are.
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.
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.
Other medicines and domperidone:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes medicines you can buy without a prescription, including herbal medicines. This is because domperidone can affect the way some other medicines work. Also, some medicines can affect the way domperidone works.
Do not use Domperidone and tell your doctor if you are taking any of the following:
• Ketoconazole tablets or liquid for fungal infections.
• Antibiotics for infections (such as erythromycin).
Taking domperidone with food and drink
It is recommended to take domperidone before meals as when taken after meals the absorption of the medicine is slightly delayed. Pregnancy and breast-feeding
Talk to your doctor or pharmacist before taking domperidone 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. This is because small amounts may pass into the mother's milk.
Driving and using machines:
Domperidone does not affect your ability to drive or use machines.
Important information about some of the ingredients of Domperidone Oral Suspension:
This medicine contains sorbitol. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking domperidone. This medicine also contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216). These substances may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.
3. HOW TO TAKE DOMPERIDONE
Always take Domperidone Oral Suspension exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth.
• Take your medicine using the plastic measuring cup provided with Domperidone Oral Suspension.
• This cup is marked in ml (millilitres) to help you measure out the correct amount of this medicine.
• Take your medicine 15 to 30 minutes before a meal and, if needed, before you go to bed.
The usual dose is:
• Adults and teenagers (over 12 years of age and who weigh more than 35kg)
Take 10ml to 20ml of the suspension, three or four times each day.
Do not take more than 80ml of Domperidone Oral Suspension a day.
• Use in children (under 12 years of age and who weigh less than 35kg)
Your doctor will work out the dose. This will depend on the weight of your child. Do not give your child any more than 80 ml of Domperidone Oral Suspension a day.
People with kidney problems
Your doctor may tell you to take a lower dose or to take the medicine less often.
How long can I take this medicine for?
Your doctor will decide how long you will need to take this medicine.
If you take domperidone for more than 2 weeks your doctor may wish to see you again. This is to check if you need to keep taking the treatment.
If you take more domperidone than you should:
• If you have taken more domperidone than you should, talk to a doctor or go to the nearest hospital casualty department straight away. Take the carton and bottle containing any remaining medicine with you. This is so the doctors know what you have taken.
• 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).
If you forget to take domperidone:
• If you forget to take domperidone, take it as soon as you remember.
• However if it is time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, domperidone can have 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.
irregular eye movements, unusual movements of the tongue, and muscle stiffness. This is more likely to happen in children. These
sign of a life-threatening heart problem.
• You notice any uncontrolled movements. These include abnormal posture such as a twisted neck, trembling and symptoms should stop once you stop taking domperidone.
• You have a very fast or unusual heartbeat. This could be a
• 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 Frequency cannot be estimated from the available data
• 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
longer term medical supervision have experienced irregular menstrual periods in women, difficulty
Some patients who have used domperidone for conditions and dosages requiring the following unwanted effects:
Restlessness; swollen or enlarged breasts, unusual discharge from breasts, breastfeeding, depression, hypersensitivity.
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.
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
• Keep out of the sight and reach of children.
• Do not store above 30°C
• Do not take Domperidone Oral Suspension after the expiry date stated on the pack.
• Ask your pharmacist how to dispose of medicines you no longer need. Do not dispose of medicines by flushing down a toilet or sink, or by throwing them out with your normal household rubbish. This will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Domperidone 1mg/ml Oral Suspension contains
Each ml of oral suspension contains 1mg of domperidone.
It also contains sorbitol liquid non-crystallising (E420), microcrystalline cellulose (E460), carmellose sodium (E466), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), sodium saccharin (E954), polysorbate 20 (E432), sodium hydroxide and purified water.
What Domperidone 1mg/ml Oral Suspension looks like and contents of the pack
Each pack contains a 200 millilitre bottle of a white coloured liquid suspension.
Manufacturer
Domperidone 1mg/ml Oral Suspension is manufactured by Laboratorios Dr. Esteve, S.A., Avda. Mare de Deu de Montserrat, 221 -08041 Barcelona, Spain. Procured from within the EU by the Product Licence Holder Polyfarma Ltd and repackaged by Kent Pharmaceuticals Ltd both at Repton Road, Measham, DE12 7DT, UK.
POM
PL No. 17211/1181
Leaflet revision and issue date: 05.12.2013.