The Proprietary Association of Great Britain (PAGB), the trade association representing manufacturers of over-the-counter medicines and food supplements, would like to highlight that the vast majority of people use medicines containing codeine and dihydrocodeine safely and correctly, and these medicines do not lead to addiction if used according to the instructions on the pack.

However, the industry recognises that a small minority of people might be at possible risk of addiction as a result of incorrect use, and takes this issue very seriously. In 2005, in a joint decision between the Medicines and Healthcare products Regulatory Agency (MHRA) and the over-the-counter medicines industry it was voluntarily agreed that strengthened warnings, about the possible risk of addiction or medication overuse headache due to inappropriate use, was added onto packs of painkillers which contain codeine and dihydrocodeine.

The following warnings appear on the packs of painkillers which contain codeine and dihydrocodeine:

-- If you need to use this medicine for more than three days at a time, see your doctor, pharmacist or health care professional.
-- Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.
-- Taking a painkiller for headaches too often or for too long can make them worse.

The industry also voluntarily agreed to a maximum pack size of 32 tablets for all over-the-counter medicines containing codeine or dihydrocodeine.

In 2005, the Sub Committee on Pharmacovigilance (SCOP) and the Committee on Safety of Medicines (CSM) assessed the number of reports of abuse of OTC codeine and dihydrocodeine containing medicines. The MHRA reviewed this report and concluded that the number of reports of abuse of OTC codeine and dihydrocodeine medicines is exceedingly small, compared to volume of sales. From the report the MHRA also concluded that the benefits of the availability of OTC medicines which contain codeine and dihydrocodeine outweigh any potential risks.

Helen Darracott, PAGB Director of Legal and Regulatory Affairs said: "OTC medicines which contain codeine or dihydrocodeine do not lead to addiction if used according to the instructions on the pack. They should be taken only to relieve symptoms of pain and only for short periods unless a doctor has advised otherwise. Combining codeine with paracetamol or ibuprofen produces pain relief products which some people find to be more effective than simple analgesics. They therefore play a useful role as over-the-counter medicines. As with all medicines, people should consult their pharmacist or doctor if their symptoms persist or get worse.

These medicines are already strictly regulated - they are only available from pharmacists and have clear instructions on how to use the medicine and when not to use the medicine. We hope by adding these extra warnings it will help the minority of people who might be at risk of addiction to use these medicines appropriately."

-- PAGB is committed to helping empower people to take an active role in managing their own health. It is therefore supportive of this and any other initiatives that are created to improve safe use of OTC medicines
-- For further information on OTC medicines containing codeine or dihydrocodeine please refer to PAGB's Q&A document.

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