Land: Israel
Språk: engelsk
Kilde: Ministry of Health
IDEBENONE
MEGAPHARM LTD
N06BX13
FILM COATED TABLETS
IDEBENONE 150 MG
PER OS
Required
SANTHERA PHARMACEUTICALS (SWITZERLAND) AG., SWITZERLAND
IDEBENONE
Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON)
2022-07-31
Patient Package leaflet in accordance with the Pharmacists ’Regulations (Preparations) 1986 The dispensing of this medicine requires a physician’s prescription Raxone Idebenone Film-coated tablets Composition : Active ingredient : Idebenone 150 mg Each tablet contains 48 mg lactose For the complete list of the inactive ingredients and allergic substances, please see section 2 “ Important information about some of the drug ingredients ”and section 6 “ Additional Information .” Read the entire leaflet carefully before using this medicine . This leaflet contains concise information about the medicine. If you have further questions, please consult your physician or pharmacist. This medicine has been prescribed for the treatment of your condition; do not pass it on to others. It may harm them even if you think their medical condition is similar to yours. This medicine is intended for adults and adolescents over the age of 12 . 1.What is this medicine intended for? Raxone Idebenone contains an active substance called Idebenone. Idebenone is intended for the treatment of visual impairment in adolescents and adults with Leber’s Hereditary Optic Neuropathy (LHON). Therapeutic group : This medicine affects the nervous system. LHON is a hereditary disease that passes in the family from one generation to another . This disease is caused by a mutation that affects the ability of eye cells to produce the energy they need in order to function properly, which causes these cells not to function . This disease may cause vision loss due to the inactivity of the eye cells responsible for vision . Treatment with Raxone Idebenone may restore the activity of energy-producing eye cells, which enables inactive cells to function again and improve vision . 2.Before using this medicine Do not use the medicine if: You are sensitive (allergic) to the active substance Idebenone or to any of the other ingredients this medicine contains (please see section 6 "Additional Information") . Special warnings regarding the use of this med read_full_document
1. NAME OF THE MEDICINAL PRODUCT Raxone Idebenone 2. 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 list of excipients, see section 6.1. 3. 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. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RAXONE IDEBENONE is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy ( LHON) (see section 5.1). 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. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS read_full_document