Revised SPC includes changes to:
- Section 4.4 - Special warnings and precautions for Use - added section regarding suicidal ideation and behaviour.
- Section 4.5 - Interaction with other medicinal products and other forms of interaction - addition of warning regarding coadministration with rifampicin and valproate blood levels. Addition of information about coadministration with topiramate and encephalopathy and/or hyperammonaemia, including monitoring recommendations.
- Section 4.8 - Undesirable Effects - adverse reactions added: agranulocytosis, angioedema, aplasia, DRESS and interaction with topiramate.