Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
rasagiline tartrate
Mylan S.A.S.
N04BD02
rasagiline
Anti-Parkinson drugs
Parkinson Disease
Rasagiline Mylan is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Revision: 3
Authorised
2016-04-04
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RASAGILINE MYLAN 1 MG TABLETS rasagiline 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 Rasagiline Mylan is and what it is used for 2. What you need to know before you take Rasagiline Mylan 3. How to take Rasagiline Mylan 4. Possible side effects 5. How to store Rasagiline Mylan 6. Contents of the pack and other information 1. WHAT RASAGILINE MYLAN IS AND WHAT IT IS USED FOR Rasagiline Mylan is used for the treatment of Parkinson’s disease. It can be used together with or without levodopa (another medicine that is used to treat Parkinson’s disease). With Parkinson’s disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a chemical in the brain involved in movement control. Rasagiline Mylan helps to increase and sustain levels of dopamine in the brain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE MYLAN _ _ DO NOT TAKE RASAGILINE MYLAN: - if you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6). - if you have severe liver problems. Do not take the following medicines while taking Rasagaline Mylan: - monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson’s disease, or used for any other indication), including medicinal and natural products without prescription e.g. St. John's Wort. - pethidine (a strong pain killer). You must wait at least 14 days after stopping Rasagiline Mylan treatment and starting treatment wi Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Rasagiline Mylan 1 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rasagiline tartrate corresponding to 1 mg rasagiline. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex tablets, debossed with ‘R9SE’ on one side and ‘1’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rasagiline Mylan is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa. _Elderly _ No change in dose is required for elderly patients. _Hepatic impairment _ Rasagiline use in patients with severe hepatic impairment is contraindicated (see section 4.3). Rasagiline use in patients with moderate hepatic impairment should be avoided. Caution should be used when initiating treatment with rasagiline in patients with mild hepatic impairment. In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4). _Renal impairment _ No change in dose is required for renal impairment. _ _ _Paediatric population _ Rasagiline is not recommended for use in children and adolescents due to lack of data on safety and efficacy. Method of administration For oral use. Rasagiline may be taken with or without food. 3 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1). Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) or pethidine (see section 4.5). At least 14 days must elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or Przeczytaj cały dokument