Diphenoxylate hydrochloride and atropine sulfate tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about LOMOTIL. It does not contain all
the available information. It does not take the place of talking to your doctor or
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
LOMOTIL against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What LOMOTIL is used for
LOMOTIL is a combination medicine used along with other measures for the treatment
of acute or chronic diarrhoea.
LOMOTIL contains diphenoxylate hydrochloride and atropine sulfate along with other
ingredients. The 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
LOMOTIL, in pack sizes of 20 and 100 tablets, is only available with a doctor's prescription.
LOMOTIL in a pack size of 8 tablets is available as a pharmacist only medicine.
Before you take LOMOTIL
When you must not use it
Do not take LOMOTIL if you are allergic to:
diphenoxylate or atropine or any of the tablet ingredients listed at the end of this
If you have an allergic reaction you may get a skin rash, difficulty in breathing,
hayfever or faintness.
You have jaundice
You have diarrhoea caused by pseudomembranous enterocolitis (a potentially serious
infection of the gut) which may occur during or up to several weeks following antibiotic
You have an inflammatory bowel disease such as ulcerative colitis or Crohn's disease
You have bacterial colitis or amoebic colitis.
You are breastfeeding. You should use an alternative form of infant feeding while
you are taking LOMOTIL
LOMOTIL passes into breast milk, so if you take LOMOTIL while breastfeeding, your
baby may have some effects from it.
LOMOTIL is not recommended for children less than 12 years old.
Children, especially very young children and those with Down's syndrome, are very
sensitive to the effects of LOMOTIL.
LOMOTIL must be kept out of the reach of children, since accidental overdose in children
may result in serious breathing difficulties, or even death.
Do not use tablets after the use by date, which appears on the label after the letters
They may have no effects at all, or an entirely unexpected effect if you use them
after the expiry date.
Do not use LOMOTIL if the packaging is torn or shows signs of tampering.
Do not use LOMOTIL to treat any other complaints unless your doctor says to.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Before you start to use LOMOTIL
You must tell your doctor if:
You are allergic to any other medicines, or foods, dyes or preservatives
You have any other medical conditions, especially:
Liver disease, jaundice
History of drug abuse
You are taking any other medicines, including medicines that you buy without a prescription
from a pharmacy, supermarket or health food shop.
Some of the medicines in common use that may interfere with LOMOTIL include:
Tranquillisers - medicines used to produce calmness, treat anxiety or help you sleep
Antidepressants - medicines used to treat depression, such as monoamine oxidase inhibitors
Barbiturates - medicines used to treat epilepsy and to help you sleep.
These medicines may be affected by LOMOTIL, or may affect how well it works. You may
need to take different amounts of your medicine or you may need to take different
medicines. Your doctor or pharmacist has a more complete list of medicines to avoid
while taking LOMOTIL.
Do not drink alcohol while taking LOMOTIL.
Tell your doctor if you become pregnant while you are taking LOMOTIL.
You should not take LOMOTIL near or at the time of giving birth, because diphenoxylate
is chemically related to medicines which can slow down the breathing of newborn infants.
How to take LOMOTIL
Follow you doctor's or pharmacist's instructions exactly on how much LOMOTIL to take
and for how long to take it.
The usual starting dose of LOMOTIL is 2 tablets, three or four times a day, until
the diarrhoea is under control.
The dose is then usually cut down, so that you are taking just enough tablets to control
the diarrhoea. This may be as few as 2 tablets a day. Please check with your doctor
as to how you should take LOMOTIL.
The usual maximum dose is 8 tablets in a day (24 hours).
Your doctor may want you to stop taking LOMOTIL when your bowel movements return to
If your diarrhoea contains blood or lasts for more than 2 days, tell your doctor.
If you take too much (overdose)
Immediately telephone your doctor, pharmacist or Poisons Information Centre (telephone
number: 131126) for advice, or go to Casualty at your nearest hospital, if you think
that you or anyone else may have taken a large number of LOMOTIL tablets. Do this
even if there are no signs of discomfort or poisoning. You may need urgent medical
Keep telephone numbers for these places handy.
If you think someone has taken an overdose of LOMOTIL, or if a child has accidentally
taken LOMOTIL tablets, you should get medical help immediately.
Signs that may indicate an overdose are: at first, dryness of the skin and mouth,
widening of the pupils of the eye, restlessness, flushing, high temperatures and rapid
heart beat, followed by lack of energy or coma, poor reflexes, constant movements
of the eyeballs, pinpoint (small) pupils and slow, shallow breathing (respiratory
depression). Sometimes respiratory depression may not occur straight away, and may
develop as late as 30 hours after an overdose. Patients should be watched for at least
48 hours, preferably in hospital.
While you are using LOMOTIL
Things you must do
Use LOMOTIL exactly as your doctor has prescribed.
Tell all doctors, dentists and pharmacists who are treating you that you are taking
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, you should 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. When the diarrhoea
has stopped gradually return to your normal diet.
Things you must not do
Do not drink alcohol or milk.
Drinking alcohol or milk can make your diarrhoea worse.
Do not eat dairy foods, fatty foods such as cakes, pies, chocolates, fatty meats and
fried foods, spicy foods, fruit or acidic vegetables.
Eating these foods can make your diarrhoea worse.
Be careful driving or operating machinery until you know how LOMOTIL affects you.
LOMOTIL can make some people drowsy or dizzy. Make sure you know how you react to
LOMOTIL before you drive a car, operate dangerous machinery, or do anything else that
could be dangerous if this happens to you.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
As well as benefits, medicines may have some effects you do not want (side effects).
Knowledge of this medicine is continually increasing. Side effects may possibly occur,
which were previously unknown, and so this list of possible side effects cannot be
complete. It is therefore important to tell your doctor if you experience any unusual
side effects or any changes in your health, while you are taking LOMOTIL.
Side effects which have been reported in patients taking LOMOTIL are:
Lack of energy
Numbness in hands and feet
Allergic wheals and swelling
Swelling of gums
Loss of appetite
Severe allergic reaction (anaphylaxis)
Obstruction or paralysis of the intestine
Reported side effects of atropine sulfate are:
Unusually high fever
Rapid heart beat
Being unable to urinate
Dry skin and
If any side effects do not settle down during treatment and are a problem for you,
or if you develop any new medical problem while you are taking LOMOTIL, tell your
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are using LOMOTIL.
LOMOTIL helps most people with diarrhoea, but it may have unwanted effects in a few
All medicines have side effects.
Sometimes they are serious, most of the time they are not. You may need medical treatment
if you get some of the side effects.
Ask your doctor or pharmacist about any questions you may have.
After using LOMOTIL
Keep it where young children cannot reach it, since overdose is especially dangerous
Do not leave it in the car on hot days.
Keep your tablets in their blister pack until it is time to take them.
Store below 30°C.
Store away from heat, direct light and steamy or damp places. Heat or moisture may
cause LOMOTIL tablets to deteriorate.
Carefully dispose of any tablets that are no longer needed or are past the expiry
date("EXP"). Ask your pharmacist for advice on disposal of medicines.
What it looks like
LOMOTIL tablets are white, uncoated, biconvex tablets marked SEARLE on one side in
blister packs of 8, 20 and 100 tablets
They contain 2.5mg diphenoxylate hydrochloride and 25 micrograms atropine sulfate.
Other ingredients in each tablet are:
Sucrose, acacia, sorbitol, talc, magnesium stearate, liquid paraffin.
LOMOTIL is distributed by:
iNova Pharmaceuticals (Australia) Pty Limited
ABN: 13 617 871 539
Level 10, 12 Help Street
Chatswood NSW 2067
Tel (Australia): 1800 630 056
®= Registered Trademark
AUST R 74475
This leaflet was prepared in November 2017.