Diphenoxylate hydrochloride and atropine sulfate tablets
Consumer Medicine Information
This leaflet answers some common questions about Lofenoxal.
It does not contain all of 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 Lofenoxal 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.
Lofenoxal is a combination medicine used along with other measures for the treatment of acute or chronic diarrhoea.
Lofenoxal 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 Lofenoxal. This causes unpleasant effects if larger than normal doses are taken, and discourages abuse.
Lofenoxal, in pack sizes of 20 tablets, is only available with a doctor’s prescription.
Do not take Lofenoxal if-
If you have an allergic reaction you may get a skin rash, difficulty in breathing, hayfever or faintness.
Lofenoxal passes into breast milk, so if you take Lofenoxal while breastfeeding, your baby may have some effects from it.
Lofenoxal 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 Lofenoxal. Lofenoxal must be kept out of the reach of children, since accidental overdose in children may result in serious breathing difficulties, or even death.
They may have no effects at all, or an entirely unexpected effect if you use them after the expiry date.
You must tell your doctor if:
Some of the medicines in common use that may interfere with Lofenoxal include:
These medicines may be affected by Lofenoxal, 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 Lofenoxal.
Do not drink alcohol while taking Lofenoxal.
Tell your doctor if you become pregnant while you are taking Lofenoxal.
You should not take Lofenoxal near or at the time of giving birth, because diphenoxylate is chemically related to medicines which can slow down the breathing of newborn infants.
Follow you doctor’s or pharmacist’s instructions exactly on how much Lofenoxal to take and for how long to take it.
The usual starting dose of Lofenoxal 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 Lofenoxal.
The usual maximum dose is 8 tablets in a day (24 hours).
Your doctor may want you to stop taking Lofenoxal when your bowel movements return to normal.
If your diarrhoea contains blood or lasts for more than 2 days, tell your doctor.
Immediately telephone your doctor, pharmacist or Poisons Information Centre (telephone number: 13 11 26) 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 Lofenoxal tablets. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you think someone has taken an overdose of Lofenoxal, or if a child has accidentally taken Lofenoxal 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.
Use Lofenoxal exactly as your doctor has prescribed.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Lofenoxal.
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 Lofenoxal.
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.
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 Lofenoxal affects you.
Lofenoxal can make some people drowsy or dizzy. Make sure you know how you react to Lofenoxal 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 Lofenoxal.
Side effects which have been reported in patients taking Lofenoxal are:
Reported side effects of atropine sulfate are:
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 Lofenoxal, tell your doctor.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Lofenoxal.
Lofenoxal helps most people with diarrhoea, but it may have unwanted effects in a few people.
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.
Keep it where young children cannot reach it, since overdose is especially dangerous in children.
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 30ºC.
Store away from heat, direct light and steamy or damp places. Heat or moisture may cause Lofenoxal 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.
LOFENOXAL tablets are white, uncoated, biconvex tablets marked SEARLE on one side in blister packs of 20 tablets
(AUST R 74476).
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.
Lofenoxal is distributed by:
Biotech Pharmaceuticals Pty Ltd
83 Cherry Lane
Telephone: (03) 9278 7555 or
Toll Free (within Australia): 1800 620 898
This leaflet was prepared in July 2007.
Published by MIMS August 2010