Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Monitoring

Patients should be regularly monitored according to local clinical practice.
Hepatic or renal impairment

Caution should be exercised when prescribing Raxone Idebenone to patients with hepatic or renal impairment. Adverse events have been reported in patients with hepatic impairment, which have resulted in temporary interruption or discontinuation of treatment 
Chromaturia

The metabolites of idebenone are coloured and may cause chromaturia, i.e. a reddish-brown discoloration of the urine. This effect is harmless, not associated with haematuria, and does not require any adaptation of dose or discontinuation of treatment. Caution should be exercised to ensure that the chromaturia does not mask changes of colour due to other reasons (e.g. renal or blood disorders).

Lactose

Raxone Idebenone contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take Raxone Idebenone.

Sunset yellow

Raxone Idebenone contains sunset yellow (E110) which may cause allergic reactions.

Effects on Driving

4.7    Effects on ability to drive and use machines

Raxone Idebenone has no or negligible influence on the ability to drive and use machines.