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Methadone PIL alert

Affected batches not being recalled

March 8th 2023

Tagged: MHRA alert

By MHRA

Several batches of Thornton & Ross methadone 1mg/mL oral solution BP sugar free and methadone mixture 1mg/mL have been packaged with the incorrect Product Information Leaflet (PIL).

Details of the affected batches are online.

The incorrect PIL is missing important 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. Links to the correct PILs are provided below:

Methadone Mixture 1mg/mL

Methadone 1mg/mL oral solution BP – sugar free

There is no risk to product quality and affected batches are not being recalled.

Healthcare professionals are asked to discuss the missing information with patients and provide a copy of the updated PIL, where appropriate. Patients should not suddenly stop taking this medicine.

For medical information queries and to request hard copies of the correct PIL, please contact [email protected]