Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Lomotil?
Lomotil contains the active ingredients diphenoxylate hydrochloride and atropine sulfate
monohydrate. Lomotil is used to for the treatment of acute or chronic diarrhoea.
2. What should I know before I use Lomotil?
Do not use if you have ever had an allergic reaction to diphenoxylate or atropine
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
are pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Lomotil and affect how it works.
4. How do I use Lomotil?
The usual starting dose is 2 tablets, three to four times daily, until the diarrhoea
is under control.
The usual maximum dose is 8 tablets in a day (24 hours).
5. What should I know while using Lomotil?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Lomotil.
Drink plenty of liquids, such as an oral rehydration solution.
Eat as little as possible for the first few days.
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Things you should not do
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Do not give Lomotil to children under 12 years of age.
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Driving or using machines
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Make sure you know how you react to Lomotil before driving or operating machinery.
Lomotil can make some people drowsy or dizzy.
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Drinking alcohol
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Do not drink alcohol while using the medicine.
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Looking after your medicine
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Store below 30°C.
Store away from heat, direct light and steamy or damp places.
Keep out of reach of children. Accidental overdosage can lead to severe breathing
problems or death.
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6. Are there any side effects?
Common side effects include nausea and vomiting, stomach upset, drowsiness and dizziness.
Serious side effects include severe allergic reactions, severe stomach or bowel problems,
fast shallow breathing, fast heartbeat, and a very high temperature.
Active ingredients:
diphenoxylate hydrochloride and atropine sulfate monohydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Lomotil. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Lomotil.
Where to find information in this leaflet:
1. Why am I using Lomotil?
Lomotil contains the active ingredients diphenoxylate hydrochloride and atropine sulfate
monohydrate. Lomotil is an anti-diarrhoeal agent. Diphenoxylate reduces diarrhoea by slowing down
the movements of the intestines. Because diphenoxylate may be abused by taking it
in doses that are larger than prescribed, a small amount of atropine sulfate is included
in LOMOTIL. This causes unpleasant effects if larger than normal doses are taken and
discourages abuse.
Lomotil is used to treat short- or long-lasting episodes of diarrhoea when used with
other measures such as oral rehydration.
2. What should I know before I use Lomotil?
Warnings
Do not use Lomotil if:
You are allergic to diphenoxylate or atropine, or any of the ingredients listed at
the end of this leaflet. Always check the ingredients to make sure you can use this
medicine.
You have jaundice.
You have diarrhoea caused by pseudomembranous enterocolitis. This is a potentially
serious infection of the gut, which may occur during or up to several weeks following
antibiotic treatment.
You have an inflammatory bowel disease such as ulcerative colitis or Crohn's disease.
You have bacterial colitis or amoebic colitis.
It is past the expiry date printed on the pack or if the packaging is torn or shows
signs of tampering.
Check with your doctor if you:
Have any other medical conditions, especially
Liver disease
Kidney disease
Down's Syndrome
A history of drug abuse
Take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant. Lomotil should not be taken near or at
the time of giving birth, because diphenoxylate is chemically related to medicines,
which can slow down the breathing of newborn infants.
Talk to your doctor if you are breastfeeding or intend to breastfeed. The active ingredients
in Lomotil may pass into breast milk. Infants of nursing mothers taking Lomotil may
show some effects of the medicine.
Use in children
Do not give Lomotil to children under 12 years of age.
Keep Lomotil out of reach of children since accidental overdosage may result in severe,
even fatal breathing problems.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Lomotil and affect how it works.
Medicines that Lomotil may
increase
the effect of include:
Tranquillisers - medicines used to produce calmness, treat anxiety, or help you sleep
Barbiturates - medicines used to treat epilepsy and to help you sleep.
Antidepressants - medicines used to treat depression, such as monoamine oxidase inhibitors
(MAOI)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Lomotil.
4. How do I use Lomotil?
How much to take
The usual starting dose is 2 tablets three or four times daily until the diarrhoea
is under control.
Do not take more than 8 tablets in 24 hours.
After the diarrhoea is under control the dosage may be reduced, so that you are taking
just enough tablets to control the diarrhoea. This may be as few as 2 tablets a day.
Your doctor will advise you how much to take.
Your doctor may want you to stop taking Lomotil when your bowel movements return to
normal.
If you forget to use Lomotil
Lomotil should be used regularly at the same time each day.
If you miss your dose at the usual time and 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 use too much Lomotil
If you think that you have used too much Lomotil, or if a child has accidentally taken
Lomotil, you should get urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Lomotil?
Things you should do
See your doctor straight away if:
the diarrhoea contains blood or continues for more than 2 days.
Drink plenty of liquids, such as an oral rehydration solution
Drinking plenty of liquids makes sure you do not become dehydrated (lose too much
liquid from your body). If you have become very dehydrated, see your doctor to make
sure this is corrected, before taking Lomotil.
Eat as little as possible for the first few days
Eat only plain, bland foods, such as unbuttered toast, plain biscuits, boiled potatoes,
rice, or pasta. Gradually return to your normal diet when the diarrhoea has stopped.
Remind any doctor, dentist, or pharmacist you visit that you are using Lomotil.
Things you should not do
Do not drink alcohol while taking Lomotil.
Do not exceed the recommended dose. Addiction to Lomotil is possible at high doses.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Lomotil
affects you.
Lomotil may cause dizziness or drowsiness in some people
Drinking alcohol
Tell your doctor if you drink alcohol.
Lomotil may increase the effects of alcohol.
Looking after your medicine
Store below 30°C.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription for packs sizes of 20
and 100 tablets.
The 8 tablet pack size is available without prescription at a pharmacy on the advice
of a pharmacist.
What Lomotil contains
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Active ingredients
(main ingredients)
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Diphenoxylate hydrochloride
Atropine sulfate monohydrate
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Other ingredients
(inactive ingredients)
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sucrose
acacia
sorbitol
talc
magnesium stearate
liquid paraffin.
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Do not take this medicine if you are allergic to any of these ingredients.
What Lomotil looks like
Lomotil is a white to off-white, uncoated biconvex tablets marked LT on one side.
Registration number: AUST R 74475
Who distributes Lomotil
iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel (Australia): 1800 630 056
This leaflet was prepared in November 2021