- domperidone maleate
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.
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: PL 17780/0300.
Motilium 10mg Film-Coated Tablets
MOTILIUM 10 mg FILM-COATED TABLETS
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
1. What Motilium is and what it is used for
2. What you need to know before you take Motilium
3. How to take Motilium
4. Possible side effects
5. How to store Motilium
6. Contents of the pack and other information
1. WHAT MOTILIUM IS AND WHAT IT IS USED FOR
The name of your medicine is Motilium 10mg Film-Coated Tablets (called Motilium in this leaflet). Motilium contains a medicine 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 MOTILIUM
Do not take Motilium tablets if:
Do not take Motilium if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Motilium.
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 Motilium. Do this even if they have applied in the past.
Motilium 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. The risk also increases when Motilium 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 Motilium).
Motilium should be used at the lowest effective dose.
While taking Motilium, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, loss of consciousness. Treatment with Motilium should be stopped.
Adolescents weighing less than 35 kg and children
Motilium 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 Motilium
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 Motilium can affect the way some other medicines work. Also, some medicines can affect the way Motilium works.
Do not take Motilium 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.
Motilium and apomorphine
Before you use Motilium 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 Motilium is safe for you when you are taking any other medicines, including medicines obtained without prescription.
Taking Motilium with food and drink
It is recommended to take Motilium 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 Motilium if:
Small amounts of Motilium have been detected in breast-milk. Motilium may cause unwanted side effects affecting the heart in a breast-fed baby. Motilium 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:
Motilium does not affect your ability to drive or use machines.
Important information about some of the ingredients of Motilium tablets
This medicine contains lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking Motilium.
3. HOW TO TAKE MOTILIUM
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 with 3-4 days of taking this medicine. Do not take Motilium 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 Motilium than you should:
If you forget to take Motilium:
4. POSSIBLE SIDE EFFECTS
Like all medicines, Motilium can have side effects, although not everybody gets them.
Stop taking Motilium 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 Motilium 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 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 MOTILIUM
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Motilium 10mg Film-Coated Tablets contain
Each Motilium Tablet contains 10mg of domperidone (the active ingredient). It also contains lactose, maize starch, microcrystalline cellulose, hypromellose, pregelatinised starch, povidone, propylene glycol, magnesium stearate, silica colloidal hydrated and polysorbate 20.
What Motilium 10mg Film-Coated Tablets look like and contents of the pack
Each pack contains 30 or 100 white to cream coloured, film-coated tablets with Motilium stamped on one side.
Marketing Authorisation Holder:
This leaflet was last revised in: March 2020
Motilium® is a registered Trademark of Johnson & Johnson Inc.
‘Zentiva is a registered trademark © 2020 Zentiva.