POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL17780/0299.
Domperidone 1mg/ml Oral Suspension
DOMPERIDONE 1 mg/ml ORAL SUSPENSION
PATIENT INFORMATION LEAFLET
▼ 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.
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 FOR
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’.
This medicine is used in adults and in adolescents 12 years of age and older to treat nausea (feeling sick) and vomiting (being sick).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOMPERIDONE
Do not take domperidone if:
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.
Warnings and precautions
Before taking this medicine contact your doctor if:
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. 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 in adults and adolescents 12 years of age and older.
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:
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 take Domperidone Oral Suspension if you are taking medicine to treat:
Tell your doctor or pharmacist if you are taking drugs to treat infection, heart problems or AIDS/HIV.
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 domperidone works. Medicines that reduce stomach acid should be taken after a meal.
Domperidone and apomorphine
Before you use domperidone 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 Oral Suspension is safe for you when you are taking any other medicines, including medicines obtained without prescription.
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:
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.
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
Follow these instructions closely unless your doctor has advised you otherwise. You should check with your doctor or pharmacist 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 Oral Suspension for longer than 7 days without consulting your doctor.
Taking this medicine
The usual dose is:
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 forget to take domperidone:
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:
Other side effects include:
Common (affects less than 1 in 10 people)
Uncommon (affects less than 1 in 100 people)
Not known (Frequency cannot be estimated from the available data)
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.
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
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Domperidone 1mg/ml Oral Suspension contains
Domperidone 1mg/ml Oral Suspension contains domperidone (the active ingredient). It also contains sorbitol, microcrystalline cellulose and carmellose sodium, methylhydroxybenzoate, propylhydroxybenzoate, sodium saccharin, polysorbate 20, sodium hydroxide and 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.
Marketing Authorisation Holder
This leaflet was last revised in: October 2017
Zentiva’ is a registered trademark. ©2017 Zentiva.