Section 4.5 (Interaction with other medicinal products and other forms of interaction) has been updated with information on the use of efavirenz and anticoagulants:
Warfarin/Efavirenz Interaction not studied. Plasma concentrations and effects of warfarin are potentially increased or decreased by efavirenz. Dose adjustment of warfarin may be required.
Section 4.8 (Undesirable effects) has been updated to include flushing, tinnitus and tremor in the post-marketing experience paragraph.