Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
SAFINAMIDE AS METHANESULFONATE
MEDISON PHARMA LTD
N04BD03
FILM COATED TABLETS
SAFINAMIDE AS METHANESULFONATE 50 MG
PER OS
Required
ZAMBON S.P.A., ITALY
SAFINAMIDE
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.
2020-05-10
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only XADAGO 50 MG XADAGO 100 MG FILM-COATED TABLETS ACTIVE INGREDIENT: Each tablet contains 50 mg or 100 mg safinamide as safinamide methanesulfonate. Inactive ingredients and allergens: see section 6 ‘Additional Information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Xadago is used to treat idiopathic (that has developed for an unknown reason) Parkinson’s disease in adult patients. It is added to a stable dose of levodopa alone or to a stable dose of levodopa in combination with other medicines for Parkinson’s disease. It is used in patients that are in the mid- to late-stage of the disease. THERAPEUTIC GROUP Parkinson medication, monoamine oxidase-B inhibitors. Xadago is a medicine that contains the active ingredient 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. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive to the active ingredient (safinamide) or to any of the other ingredients in this medicine (see the list in section 6). You are taking any of the following medicines: o monoamine oxidase inhibitors (MAO) such as selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine (for example to treat Parkinson’s disease or depression, or any other condition). o pethidine (a strong pain killer). You must wait at least 7 days after stopping Xadago before starting treatment with Soma hati kamili
XADAGO-SPC-0820-V1 Page 1 of 14 PHYSICIAN’S PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Xadago 50 mg Xadago 100 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Xadago 50 mg : Each film-coated tablet contains safinamide methanesulfonate equivalent to 50 mg safinamide. Xadago 100 mg : Each film-coated tablet contains safinamide methanesulfonate equivalent to 100 mg safinamide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Xadago 50 mg film-coated tablets Orange to copper with metallic gloss, round, biconcave, 7 mm film-coated tablets, embossed with “50” on one side. Xadago 100 mg film-coated tablets Orange to copper with metallic gloss, round, biconcave, 9 mm film-coated tablets, embossed with “100” on one side. 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 Xadago 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. _Hepatic impairment _ Xadago 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 XADAGO-SPC-0820-V1 Page 2 of 14 recommended for patients with moderate hepatic impairment. If patients progress from moderate to severe hepatic impairment Xadago should be stopped (see section 4.4). _Renal impairment _ No change in dose is required for patients with renal impairment. _Paediatric population _ Xadag Soma hati kamili