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16/08/2005
Painkiller warnings to be updated
Over-the-counter painkillers are set to carry stronger warnings about the risk of addiction and possible side effects.
The industry regulators, the Medicines and Healthcare products Regulatory Agency (MHRA) asked manufacturers to voluntarily update the Patient Information Leaflets (PILs) and labelling of painkillers that contained codeine and dihydrocodeine.
The updated warnings will inform patients that taking codeine regularly could lead to addiction and will advise patients to see their doctor if they need to take the medication for more than three days at a time.
The warnings will also advise patients that taking a painkiller to ease headaches for too often or too long, can actually make them worse.
The MHRA says that these precautions could help prevent a small number of people of people becoming addicted to the medication.
The industry has also voluntarily agreed to a maximum pack size of 32 tablets for all over-the-counter medicines containing codeine or dihydrocodeine.
Helen Darracott, Director of Legal and Regulatory Affairs at the Proprietary Association of Great Britain, welcomed the decision. She said: “OTC medicines which contain codeine or dihyrdocodeine do not lead to addiction if used according to the instruction 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 paracetemol or ibuprofen produces pain relief products, which have been shown 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.
Ms Darracott added: “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.”
(KMcA/SP)
The industry regulators, the Medicines and Healthcare products Regulatory Agency (MHRA) asked manufacturers to voluntarily update the Patient Information Leaflets (PILs) and labelling of painkillers that contained codeine and dihydrocodeine.
The updated warnings will inform patients that taking codeine regularly could lead to addiction and will advise patients to see their doctor if they need to take the medication for more than three days at a time.
The warnings will also advise patients that taking a painkiller to ease headaches for too often or too long, can actually make them worse.
The MHRA says that these precautions could help prevent a small number of people of people becoming addicted to the medication.
The industry has also voluntarily agreed to a maximum pack size of 32 tablets for all over-the-counter medicines containing codeine or dihydrocodeine.
Helen Darracott, Director of Legal and Regulatory Affairs at the Proprietary Association of Great Britain, welcomed the decision. She said: “OTC medicines which contain codeine or dihyrdocodeine do not lead to addiction if used according to the instruction 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 paracetemol or ibuprofen produces pain relief products, which have been shown 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.
Ms Darracott added: “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.”
(KMcA/SP)
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