Raxone

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). 1). 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 been investigated. However, no specific posology recommendations can be made. 4). 3 In the absence of sufficient clinical data, caution should be exercised in patients with renal impairment.

Paediatric population The safety and efficacy of Raxone in LHON patients under 12 years of age have not yet been established. 2, but no recommendation on posology can be made. Method of administration Raxone film-coated tablets should be swallowed whole with water.

The tablets should not be broken or chewed. Raxone should be administered with food because food increases the bioavailability of idebenone.

Summary of the safety profile The most commonly reported adverse reactions to idebenone are mild to moderate diarrhoea (usually not requiring the discontinuation of the treatment), nasopharyngitis, cough and back pain. Tabulated list of adverse reactions The following adverse reactions emerging from clinical trials in LHON patients or reported post- marketing in other indications are tabulated below.

Frequency groupings are defined to the following convention: very common (≥1/10), common (≥1/100 to <1/10), not known (cannot be estimated from the available data). System Organ Class Preferred Term Frequency Infections and Infestations Nasopharyngitis Very common Bronchitis Not known Blood and lymphatic system disorders Agranulocytosis, anaemia, leukocytopenia, thrombocytopenia, neutropenia Not known Metabolism and nutrition disorders Blood cholesterol increased, blood triglycerides increased Not known 5 System Organ Class Preferred Term Frequency Nervous system disorders Seizure, delirium, hallucinations, agitation, dyskinesia, hyperkinesia, poriomania, dizziness, headache, restlessness, stupor Not known Respiratory, thoracic and mediastinal disorders Cough Very common Gastrointestinal disorders Diarrhoea Common Nausea, vomiting, anorexia, dyspepsia Not known Hepatobiliary disorders Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gamma- glutamyltransferase increased, blood bilirubin increased, hepatitis Not known Skin and subcutaneous tissue disorders Rash, pruritus Not known Musculoskeletal and connective tissue disorders Back pain Common Pain in extremity Not known Renal and urinary disorders Azotaemia, chromaturia Not known General disorders and administration site conditions Malaise Not known Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Monitoring Patients should be regularly monitored according to local clinical practice. Hepatic or renal impairment Caution should be exercised when prescribing Raxone 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.

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. g. renal or blood disorders). Lactose Raxone contains lactose.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take Raxone. Sunset yellow Raxone contains sunset yellow (E110) which may cause allergic reactions.

1.