SPC updated as follows:
Section 4.4 Special warnings and precautions for use - Inclusion of information concerning medication overuse headache
Section 4.8 Undesirable effects - Frequency bands revised; inclusion of additional side effects of hypersensitivity reactions, anaphylactic/anaphylactoid reactions, dizziness, somnolence, peripheral vascular ischaemia, asthenia/fatigue.