Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
safinamide methanesulfonate
Zambon SpA
N04B
safinamide
Anti-Parkinson drugs
Parkinson Disease
Xadago is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.
Revision: 13
Authorised
2015-02-23
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XADAGO 50 MG FILM-COATED TABLETS XADAGO 100 MG FILM-COATED TABLETS safinamide 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Xadago is and what it is used for 2. What you need to know before you take Xadago 3. How to take Xadago 4. Possible side effects 5. How to store Xadago 6. Contents of the pack and other information 1. WHAT XADAGO IS AND WHAT IT IS USED FOR Xadago is a medicine that contains the active substance safinamide. It acts to increase the level of a substance called dopamine in the brain, which is involved in the control of movement and is present in reduced amounts in the brain of patients with Parkinson’s disease. Xadago is used for the treatment of Parkinson’s disease in adults. In mid- to late-stage patients experiencing sudden switches between being “ON” and able to move and being “OFF” and having difficulties moving about, Xadago is added to a stable dose of the medicine called levodopa alone or in combination with other medicines for Parkinson’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XADAGO DO NOT TAKE XADAGO - If you are allergic to safinamide or any of the other ingredients of this medicine (listed in section 6). - If you are taking any of the following medicines: - Monoamine oxidase (MAO) inhibitors such as selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine (e.g. for treatment of Parkinson’s disease or depression, or used for any other condition). - Pethidine (a strong pain Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Xadago 50 mg film-coated tablets Each film-coated tablet contains safinamide methansulfonate equivalent to 50 mg safinamide. Xadago 100 mg film-coated tablets Each film-coated tablet contains safinamide methansulfonate equivalent to 100 mg safinamide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Xadago 50 mg film-coated tablets Orange to copper, round, biconcave, film-coated tablet of 7 mm diameter with metallic gloss, embossed with the strength “50” on one side of the tablet. Xadago 100 mg film-coated tablets Orange to copper, round, biconcave, film-coated tablet of 9 mm diameter with metallic gloss, embossed with the strength “100” on one side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xadago is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as add-on therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment with safinamide should be started at 50 mg per day. This daily dose may be increased to 100 mg/day on the basis of individual clinical need. If a dose is missed the next dose should be taken at the usual time the next day. Elderly No change in dose is required for elderly patients. Experience of use of safinamide in patients over 75 years of age is limited. 3 Hepatic impairment Safinamide use in patients with severe hepatic impairment is contraindicated (see section 4.3). No dose adjustment is required in patients with mild hepatic impairment. The lower dose of 50 mg/day is recommended for patients with moderate hepatic impairment. If patients progress from moderate to severe hepatic impairment safinamide should be stopped (see section 4.4). Rena Прочетете целия документ