Posology : מינונים

4.2    Posology and method of administration

Treatment should be initiated and supervised by a physician with experience in LHON.
Posology

The recommended dose is 900 mg/day idebenone (300 mg, 3 times a day).

No data regarding a continuous treatment with idebenone beyond 6 months is available from controlled clinical trials.

Special populations

Elderly
No specific dose adjustment is required for the treatment of LHON in elderly patients.

Hepatic or renal impairment

Patients with hepatic or renal impairment have not been investigated. Caution is advised in treatment of patients with hepatic or renal impairment (see section 4.4).
Paediatric population

The safety and efficacy of Raxone Idebenone in LHON patients under 12 years of age have not yet been established. Currently available data are described in sections 5.1 and 5.2, but no recommendation on posology can be made.

Method of administration

Raxone Idebenone film-coated tablets should be swallowed whole with water. The tablets should not be broken or chewed. Raxone Idebenone should be administered with food because food increases the bioavailability of idebenone.