Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
rasagiline
Teva B.V.
N04BD02
rasagiline
Anti-Parkinson drugs
Parkinson Disease
Azilect 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: 23
Authorised
2005-02-21
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE USER AZILECT 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 AZILECT is and what it is used for 2. What you need to know before you take AZILECT 3. How to take AZILECT 4. Possible side effects 5. How to store AZILECT 6. Contents of the pack and other information 1. WHAT AZILECT IS AND WHAT IT IS USED FOR AZILECT contains the active substance rasagiline and it is used for the treatment of Parkinson’s disease in adults. 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. AZILECT helps to increase and sustain levels of dopamine in the brain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZILECT DO NOT TAKE AZILECT - 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 AZILECT: - 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 AZILECT treatment and starting treatment with MAO inhibitors or pethidine. WARNINGS AND PRECAUTIONS T Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT AZILECT 1 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg rasagiline (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AZILECT is indicated in adults for the treatment of idiopathic Parkinson’s disease 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 The recommended dose of rasagiline is 1 mg (one tablet of AZILECT) once daily, to be taken with or without levodopa. _Elderly_ No change in dose is required for elderly patients (see section 5.2). _Hepatic_ _ impairment_ Rasagiline is contraindicated in patients with severe hepatic impairment (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 and 5.2). _Renal impairment_ No special precautions are required in patients with renal impairment. _ _ _Paediatric population_ The safety and efficacy of AZILECT in children and adolescents have not been established. There is no relevant use of AZILECT in the paediatric population in the indication Parkinson’s disease. Method of administration For oral use. AZILECT 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 1 Прочетете целия документ