The Pharmaceutical Journal
Vol 275 No 7362 p183
13 August 2005

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News summary

Codeine and dihydrocodeine limited to 32 per pack

Pharmacy packs of analgesics containing codeine or dihydrocodeine are to be limited to a maximum pack size of 32 and new warnings are to be added to the patient information leaflets, the Medicines and Healthcare products Regulatory Agency has announced.

The new warnings will state:

· 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 decision to reduce the maximum pack size available for pharmacy supply and to include the warnings follows a review of the evidence that these products can cause addiction or medication-overuse headache. The MHRA says that since the yellow card reporting system was established there have been just 47 reports of abuse or misuse of over-the-counter products containing codeine and that about 615 million tablets of the best selling brands are sold each year.

It acknowledges that the misuse and abuse of these products is under-reported, but says that there is unlikely to be a major hidden problem.

Following the review, the Committee on Safety of Medicines concluded that the benefit of using these medicines outweighs the potential risks and that there is no reason why these medicines should not continue under pharmacy supply.

The MHRA says that the changes will be introduced over the next year and should be in place by 30 June 2006. Relevant warnings will also be added to prescription items containing codeine or dihydrocodeine.

Pharmacists should continue to give appropriate advice in the normal way to new customers who receive these products.