Paracetamol should be taken at the approved dose

20 June 2014

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20 June 2014 - The Australian Self Medication Industry (ASMI) today reaffirmed that paracetamol has a well-known safety profile, particularly at usual doses.

This was in response to research published in Emergency Medicine Australasia which calls on authorities to restrict pack sizes to reduce the risk of deliberate paracetamol overdose. The author of the article, Professor Andis Graudins, warned that large packs of modified release paracetamol used for arthritis are putting patients at greater risk of a larger overdose.

Professor Graudins is concerned that delayed absorption of slow release paracetamol products may mean that the concentration of paracetamol is at non-toxic levels when diagnostic tests are initially done in the emergency department, yet they may rise to toxic levels once the slow release mechanism kicks in.

Importantly, there are widely accepted and used paracetamol overdose guidelines in place which outline appropriate practices for the management of slow release paracetamol products.

ASMI Director Regulatory and Scientific Affairs, Steve Scarff, said that paracetamol overdoses are concerning and the industry is committed to adopting best practice in all aspects of analgesic use to minimise the risk of overdose.

"Last year the size of packs containing paracetamol that are available over-the-counter in supermarkets reduced from 25 to 20 tablets. Consumers now need to visit a community pharmacy to purchase packs of paracetamol containing more than twenty 500mg tablets, capsules or caplets.

"Worldwide, paracetamol has a long history of use and a well-established safety profile. It has been available in Australia for many years, but like all medicines it must be taken only as directed.

"The recommended paracetamol dose for adults and children 12 years and over is 500 to 1000 mg every four to six hours as necessary, with a maximum of 4000 mg in any 24 hour period. 1

"When taking an analgesic, like any medicine, it is important that consumers adhere to approved doses and warning statements on the pack.

"Consumers who have concerns about their medicines should seek advice from ahealthcare professional," Mr Scarff continued.

About ASMI: The Australian Self Medication Industry (ASMI) is the peak body representing sponsors of non-prescription medicines - over-the-counter (OTC) and complementary medicines. Its members make up 85 per cent of the $4bn self care market. Membership totals 60 companies and ASMI members employ approximately 18,000 people with exports estimated at $1.2 billion annually. ASMI's mission is to promote better health through responsible self care. This means ensuring that safe and effective self care products are readily available to all Australians at a reasonable cost. ASMI works to encourage responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad national health

1. Australian Government: Department of Health and Ageing. Therapeutics Goods Administration. Recommended paracetamol doses. Available at

For more information or to arrange a media interview, please contact:
Marie Kelly-Davies
PR Manager, Australian Self Medication Industry (ASMI)
M:0408 256 381 E: