RAXONE Film-coated tablet Ref.[9792] Active ingredients: Idebenone

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Santhera Pharmaceuticals (Deutschland) GmbH, Marie-Curie Strasse 8, 79539 Lรถrrach, Germany, Tel: +49 (0) 7621 1690 200, Fax: +49 (0) 7621 1690 201, Email: office@santhera.com

Therapeutic indications

Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON) (see section 5.1).

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 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 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.

Overdose

No report of overdose has been received from the RHODOS study. Doses up to 2,250 mg/day have been administered in clinical studies showing a safety profile consistent with that reported in section 4.8.

There is no specific antidote for idebenone. When needed, supportive symptomatic treatment should be given.

Shelf life

5 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

White high-density polyethylene bottles with white polypropylene child-resistant tamper-evident twist-off caps containing 180 film-coated tablets.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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