ASMI supports voluntary move to add front-of-pack warnings to S3 codeine-containing analgesics

19 December 2013

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19 December 2013 - The Australian Self Medication Industry (ASMI) has today confirmed that it supports industry-wide measures for a voluntary front-of-pack warning statement to be added to S3 codeine-containing analgesics, and that ASMI members who supply these products have agreed to implement the voluntary label changes as soon as possible.

The voluntary label change will not apply to cough and cold products containing codeine. These products are not known to be associated with codeine misuse and addiction.
In 2014, consumers will start to see the following warning on the front of S3 codeine-containing analgesic products supplied by ASMI members: May cause addiction. For three days use only.

This statement is in line with warnings that currently appear on the back of some S3 codeine-containing analgesic products that are marketed jointly in Australia and New Zealand.

S3 codeine-containing analgesics, when taken according to the directions on the pack, are an effective short-term option for temporary relief of moderate-to-strong pain. In Australia, these medicines are only available behind the counter in pharmacy after consultation with a pharmacist, and are intended strictly for short term use with pack sizes limited to five days' supply.

ASMI Executive Director Dr Deon Schoombie commented that the decision to implement voluntary label changes to S3 codeine-containing analgesics followed months of consultation with ASMI members and the Therapeutic Goods Administration (TGA).
"While the vast majority of people who use S3 codeine-combination analgesics do so responsibly, the issue of misuse and addiction to these products is a serious health issue, and one that prompted ASMI and its members to work closely with the TGA on ways to ensure that these products are used safely and that the risk of addiction is minimised.

"The agreement from industry to implement the voluntary label changes reflects its commitment to the quality use of medicines. It will also provide support to pharmacists who will be able to raise the risk of addiction to consumers in a non-confrontational way," said Dr Schoombie.

Dr Schoombie added that ASMI is committed to working with all relevant stakeholders - particularly the TGA, the Pharmacy Guild and Pharmaceutical Society of Australia - to ensure a smooth transition as the voluntary label changes to S3 codeine-containing analgesics are implemented.

In ASMI's view, care ought to be exercised if applying stickers designed for a particular analgesic product onto the labels of any other codeine containing product.
For more information or to arrange a media interview, please contact:
Michelle Sollitt-Davis
PR Manager, Australian Self Medication Industry (ASMI)
M:0422 084 951 E:

About ASMI: The Australian Self-Medication Industry (ASMI) is the peak industry body for the Australian self care industry representing consumer healthcare products including over-the-counter medicines and complementary medicines. 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 strategy.