The PRAC has also recommended changes to the product information for methadone tablets containing low molecular weight povidone to reinforce the message that they are for oral administration only and must not be taken in any other way.
The PRAC recommendation will be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for consideration. If the CMDh position is agreed by consensus the agreement will be implemented by the Member States where the medicines are authorised, according to an agreed timetable. A final EU decision is therefore awaited, and MHRA guidance may be issued in due course.