Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
idebenone
Chiesi Farmaceutici S.p.A
N06BX13
idebenone
Other psychostimulants and nootropics, Psychoanaleptics,
Optic Atrophy, Hereditary, Leber
Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).
Revision: 9
Authorised
2015-09-08
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE USER RAXONE 150 MG FILM-COATED TABLETS idebenone This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Raxone is and what it is used for 2. What you need to know before you take Raxone 3. How to take Raxone 4. Possible side effects 5. How to store Raxone 6. Contents of the pack and other information 1. WHAT RAXONE IS AND WHAT IT IS USED FOR Raxone contains a substance called idebenone. Idebenone is used to treat vision impairment in adults and adolescents with an eye disease called Leber’s Hereditary Optic Neuropathy (LHON). - This eye problem is inherited – this means it runs in families. - It is caused by a problem with your genes (called a “genetic mutation”) that affects the ability of cells in the eye to produce the energy they need to work normally, so they become inactive. - LHON can lead to loss of eyesight due to the inactivity of cells responsible for vision. Treatment with Raxone can restore the ability of cells to produce energy and so allow inactive eye cells to work again. This can lead to some improvement in lost eyesight. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAXONE DO NOT TAKE RAXONE - if you are allergic to idebenone or any of the other ingredients of this medicine (listed in section 6). Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Raxone 150 mg film-coated tablets 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 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). Data regarding continuous treatment with idebenone for up to 24 months are available as part of a Natural History controlled open label clinical trial (see section 5.1). 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. Caution is advised in treatment of patients with hepatic or renal 3 impairment, since adverse events have resulted in temporary interruption or discontinuation of treatment (see section 4.4). In the absence of sufficient clinical data, caution should be exercised in patients with renal impairment. _ _ _Paediatric population _ The safe Прочетете целия документ