Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about MOTILIUM tablets. It does not contain all the available information. It
does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking MOTILIUM against the benefits this
medicine is expected to have for you.
If you have any concerns about taking MOTILIUM ask your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What MOTILIUM is used for
MOTILIUM is used to treat the following conditions in adults:
nausea and vomiting
discomfort caused by a slow moving stomach known as gastroparesis. Symptoms include not being able to finish a meal, a feeling
of being "too full" or bloated after a meal, a loss of appetite, feeling sick and maybe vomiting, or belching without relief.
MOTILIUM is an antiemetic and a prokinetic medicine. It works by blocking the action of a chemical messenger in the brain
which causes the feeling of nausea and vomiting, as well as increasing the movement or contractions of the stomach and intestines,
allowing food to move more easily through the stomach.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed MOTILIUM for another reason.
Before you take MOTILIUM
When you must not take it
Do not take MOTILIUM if:
you have an allergy to MOTILIUM, or any of the ingredients. See Product Description at the end of this leaflet for a list
you have a tumour of the pituitary gland called prolactinoma.
you have or have had liver disease
an increase in stomach or bowel contractions, for example, if you have had bleeding, a blockage or puncture in your gastrointestinal
you have problems with your heart, including abnormal heart beat
you are taking another medicine containing the active ingredient ketoconazole, voriconazole, itraconazole, posaconazole which
is used to treat fungal infections.
you are taking another medicine containing the active ingredient ritonavir or saquinavir which is used to treat HIV.
you are taking another medicine containing the active ingredient telaprevir which is used to treat hepatitis C.
you are taking an antibiotic containing the active ingredient erythromycin, clarithromycin or telithromycin.
Do not use MOTILIUM if the original packaging is torn or shows signs of tampering. Do not use MOTILIUM beyond the expiry
date (month and year) printed on the pack.
Before you start to take it
You must tell your doctor if:
you are pregnant or planning to become pregnant
you are breast feeding or wish to breastfeed
you have a pre-existing heart condition
you have or have ever had kidney disease
you have or have ever had breast cancer
you are not able to digest lactose which is a sugar found in milk and milk products.
MOTILIUM should not be used in children.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking or are given MOTILIUM.
Your doctor will advise you whether or not to take MOTILIUM or if you need to adjust the dose or alter your treatment.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from
your pharmacy, supermarket or health food shop.
In particular, tell your doctor or pharmacist if you are taking any of the following:
medicines for treating fungal infections, such as ketoconazole, fluconazole, itraconazole and voriconazole
anticholinergic drugs (used to prevent travel sickness
dopaminergic agonists (used to treat Parkinson's Disease or digestive disorders
an antibiotic, such as clarithromycin, telithromycin and erythromycin
medicines used to treat HIV infections, such as amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir and
medicines used to treat high blood pressure or chest pain, such as diltiazem and verapamil
amiodarone used to treat fast heart rate
aprepitant used to treat nausea and vomiting
an antidepressant called nefazodone
medicines that neutralise or reduce the amount of stomach acid, such as antacids. Do not take medicines that neutralise stomach
acid or medicines that reduce the production of stomach acid within 2 hours of taking MOTILIUM. This is because sufficient
stomach acid is required to ensure that MOTILIUM is properly absorbed by the body.
These medicines may be affected by MOTILIUM or may affect how well MOTILIUM works. Your doctor or pharmacist can tell you
what to do if you are taking any of these medicines.
How to take MOTILIUM
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help.
How much to take
The usual dose in adults is one tablet three times a day.
For nausea and vomiting this medicine is usually used for a maximum of 1 week.
The other conditions the initial duration of treatment is up to a maximum of 4 weeks.
How to take it
MOTILIUM is best taken 15 to 30 minutes before meals, and if necessary at bedtime.
If you do not understand the instructions provided with this medicine, ask your doctor or pharmacist for help.
If you forget to take it
Try to take each dose at the scheduled time.
The missed dose should be omitted and the actual dosing schedule resumed. If it is almost time for your next dose, skip the
dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you have missed more than one dose, or are not sure what to do, check with your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and
Emergency at the nearest hospital, if you think that you or anyone else may have taken too much MOTILIUM. Do this even if
there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Poisons Information Centre telephone numbers:
Australia: 13 11 26
New Zealand: 0800 POISON (or 0800 764766)
Keep these telephone numbers handy.
If you take too much MOTILIUM you may experience agitation, seizure, drowsiness, confusion and uncontrolled movements, such
as irregular eye movements, or abnormal posture like twisted neck.
While you are using MOTILIUM
A risk of unusual heart beat or sudden heart failure has been associated with MOTILIUM use. The risk is higher in patients
older than 60 years or taking more than three tablets daily. MOTILIUM should be used with caution and should be taken at the
lowest effective dose, particularly in older patients. Talk to your doctor if you have a pre-existing heart condition. Treatment
with MOTILIUM should be stopped if signs or symptoms occur that may be associated with unusual heart beat, please talk to
your doctor for advice.
Things you must do
Always follow your doctor's instructions carefully.
Tell your doctor if you become pregnant while taking MOTILIUM.
If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking MOTILIUM.
Things you must not do
Do not drive or use machinery or engage in other activities requiring mental alertness or co-ordination until you know how
this medication affects you.
Do not use MOTILIUM to treat any other complaint unless your doctor says so.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment
if you get some side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you experience any of the following:
headache, trouble sleeping, nervousness, depression dizziness, tiredness or irritability
sleepiness or drowsiness, fits or seizures, agitation
dry mouth or thirst
regurgitation, diarrhoea, constipation, nausea, changes in appetite or heartburn
rash or itchy skin
itchy eyes and crusty eyelids with discharge
mouth ulcers or cold sores.
These are mild side effects of MOTILIUM. Tell your doctor if they continue.
uncontrollable movements of the face or arms and legs, excessive trembling, excessive muscle stiffness or muscle spasm
irregular or no menstrual period
unusual secretion of breast milk or decrease in sex drive in men or women
breast tenderness or breast enlargement in men and women.
These effects will reverse on stopping treatment.
Tell your doctor immediately if you notice any of the following as you may need urgent medical care:
fast or irregular heart beats
swelling of hands, ankles or feet
passing urine more frequent or pain when passing urine.
STOP using MOTILIUM and tell your doctor immediately if any of the following happen:
you have an allergic reaction to MOTILIUM (allergy can be recognised, for instance, by skin rash, itching, shortness of breath
and/or swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing)
Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.
After using MOTILIUM
Keep MOTILIUM tablets in the pack until it is time to take them.
Keep MOTILIUM tablets in a cool dry place where the temperature is below 30°C.
Keep your medicines where children cannot reach them. A locked cupboard at least one-and-a-half metres (1.5 m) above the
ground is a good place to store medicines.
Do not store MOTILIUM tablets, or any other medicine, in the bathroom or near a sink. Do not leave medicines in the car or
on windowsills. Heat and dampness can destroy some medicines.
If your doctor tells you to stop taking MOTILIUM or the expiry date has passed, ask your pharmacist what to do with any medicine
that is left over.
What it looks like
MOTILIUM tablets are white, film coated, round tablets. Each tablet is marked "M/10" on one side and "JANSSEN" on the reverse.
They are available in blister in carton of 25 or 100 tablets. (AUST R 39510)
Each MOTILIUM tablet contains:
10 mg of domperidone as the active ingredient.
lactose, maize starch, microcrystalline cellulose, pregelatinised potato starch, povidone, magnesium stearate, hydrogenated
cottonseed oil, sodium lauryl sulfate andhypromellose.
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Road
North Ryde NSW 2113 Australia
Telephone: 1800 226 334
NZ Office: Auckland, New Zealand
Telephone: 0800 800 806 (toll free)
This leaflet was prepared in September 2016.