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RAXONE Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Raxone 150 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 150 mg idebenone. Excipients with known effect: Each film-coated tablet contains 46 mg of lactose (as monohydrate) and 0.23 mg of sunset yellow FCF (E110). For the full ...

Pharmaceutical form

Film-coated tablet. Orange, round, biconvex film-coated tablet of 10 mm diameter, engraved with the Santhera logo on one side and 150 on the other side.

Therapeutic indications

Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Lebers 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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Monitoring Patients should be regularly monitored according to local clinical practice. Hepatic or renal impairment No data are available in these populations. Therefore, caution should be exercised when ...

Interaction with other medicinal products and other forms of interaction

Data from in vitro studies have demonstrated that idebenone and its metabolite QS10 do not exert systemic inhibition of cytochrome P450 isoforms CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4 at clinically relevant ...

Fertility, pregnancy and lactation

Pregnancy The safety of idebenone in pregnant women has not been established. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Idebenone should only ...

Effects on ability to drive and use machines

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

Undesirable effects

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 ...

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. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Psychoanaleptics, Other psychostimulants and nootropics ATC code: N06BX13 Mechanism of action Idebenone, a short-chain benzoquinone, is an anti-oxidant assumed to be capable ...

Pharmacokinetic properties

Absorption Food increases the bioavailability of idebenone by approximately 5-7-fold and therefore, Raxone should always be administered with food. The tablets should not be broken or chewed. After oral ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...

List of excipients

Tablet core: Lactose monohydrate Cellulose, microcrystalline Croscarmellose sodium Povidone (K25) Magnesium stearate Silica, colloidal anhydrous Film-coating: Macrogol (3350) Poly(vinyl alcohol) Talc ...

Incompatibilities

Not applicable.

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.

Marketing authorization holder

Santhera Pharmaceuticals (Deutschland) GmbH, Marie-Curie Strasse 8, 79539 Lörrach, Germany, Tel: +49 (0) 7621 1690 200, Fax: +49 (0) 7621 1690 201, Email: office@santhera.com

Marketing authorization number(s)

EU/1/15/1020/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 8 September 2015

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