Section 4.8 Undesirable effects
Restless legs syndrome, Nausea, Oral mucosal lesions (ulcerations, blistering and
inflammation) (frequency not known).
In addition the following sentence has been revised (added text in red).
There have been postmarketing reports of serious hypersensitivity reactions in patients treated with asenapine, including anaphylactic/ anaphylactoid reactions, such as swollen tongue and swollen throat (pharyngeal oedema).