Batches of Methadone 1mg/ml Oral Solution BP Sugar Free and Methadone Mixture 1mg/ml have been packaged with the incorrect patient information leaflet (PIL), the Medicines and Healthcare Products Regulatory Agency (MHRA) has advised.

Manufacturer Thornton & Ross Ltd says specific batches of methadone have been packaged with the incorrect PIL, which is ‘missing important safety information’, the MHRA said.

However, the issue poses no risk to product quality and the batches are not being recalled, the regulator advised.

Healthcare professionals are advised to discuss the missing information with patients and provide a copy of the updated PIL, where appropriate.

The missing information in the PIL provides additional safety information related to dependency, addiction and withdrawal reactions; potential effects on hormones; safety information about pregnancy and breastfeeding; and potential interactions with other medicines.

‘Supervised consumption of methadone means that it is usually administered in the presence of a healthcare professional, who can advise the patient on important safety information and precautions,’ the MHRA said.

Batches already packaged with the incorrect PIL will continue to be distributed as ‘the MHRA considers these products critical for patients’, it said.