Consumer medicine information



Active ingredients: diphenoxylate hydrochloride and atropine sulfate monohydrate

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?
2. What should I know before I use Lomotil?
3. What if I am taking other medicines?
4. How do I use Lomotil?
5. What should I know while using Lomotil?
6. Are there any side effects?
7. Product details

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?


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

Less serious side effects What to do
Stomach related:

  • Nausea or vomiting
  • Loss of appetite
  • Abdominal discomfort

Nervous system related:

  • Drowsiness
  • Dizziness
  • Confusion
  • Lacking energy
  • Depression or euphoria
  • Headache
  • Numbness of extremities
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects What to do
Signs of an allergic reaction:

  • Rash
  • Allergic wheals and swelling
  • Swelling of the gums

Signs of atropine poisoning:

  • Unusually high fever
  • Rapid heartbeat
  • Unable to urinate
  • Dry skin and mucous membranes
  • Flushing of the skin

Signs of an overdose:

  • Slow, shallow breathing or abnormally rapid breathing
  • Pinpoint pupils or other visual changes
  • Lethargy or coma.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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 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

Active ingredients
(main ingredients)
Diphenoxylate hydrochloride
Atropine sulfate monohydrate
Other ingredients
(inactive ingredients)
magnesium stearate
liquid paraffin.

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