Land: Malta
Tungumál: enska
Heimild: Medicines Authority
RASAGILINE
Evopharm s.r.o Vyšehradská 12 Bratislava, 851 06, Slovakia
N04BD02
RASAGILINE 1 mg
TABLET
RASAGILINE 1 mg
POM
ANTI-PARKINSON DRUGS
Withdrawn
2016-08-22
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER RASAGILINE EVOPHARM 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. 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 Evopharm is and what it is used for 2. What you need to know before you take Rasagiline Evopharm 3. How to take Rasagiline Evopharm 4. Possible side effects 5. How to store Rasagiline Evopharm 6. Contents of the pack and other information 1. WHAT RASAGILINE EVOPHARM IS AND WHAT IT IS USED FOR Rasagiline Evopharm 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 Evopharm helps to increase and sustain levels of dopamine in the brain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE EVOPHARM DO NOT TAKE RASAGILINE EVOPHARM - if you are allergic (hypersensitive) to rasagiline or any of the other ingredients of Rasagiline Evopharm . - if you have severe liver problems. DO NOT TAKE THE FOLLOWING MEDICINES WHILE TAKING RASAGILINE EVOPHARM : - 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 Evopharm treatment and startin Lestu allt skjalið
Page 1 of 9 1. NAME OF THE MEDICINAL PRODUCT Rasagiline Evopharm 1 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg rasagiline (as hemitartrate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Round, white or almost white tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rasagiline Evopharm 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. It may be taken with or without food. _Elderly: _ No change in dose is required for elderly patients. _Paediatric population_ _:_ Rasagiline Evopharm is not recommended for use in children and adolescents due to lack of data on safety and efficacy. _Patients with 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). _Patients with renal impairment_ : No change in dose is required for renal impairment. 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 pethidine. Page 2 of 9 Rasagiline is contraindicated in patients with severe hepatic impairment. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The concomitant use of rasa Lestu allt skjalið