Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
RASAGILINE
Combino Pharma (Malta) Ltd. HF60, Hal Far Industrial Estate, BBG07, Hal Far, Malta
N04BD02
RASAGILINE 1 mg
TABLET
RASAGILINE 1 mg
POM
ANTI-PARKINSON DRUGS
Withdrawn
2016-09-06
1 PACKAGE LEAFLET: INFORMATION FOR THE USER RASAGILINE VANCOMBEX 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 Vancombex is and what it is used for 2. What you need to know before you take Rasagiline Vancombex 3. How to take Rasagiline Vancombex 4. Possible side effects 5. How to store Rasagiline Vancombex 6. Contents of the pack and other information 1. WHAT RASAGILINE VANCOMBEX IS AND WHAT IT IS USED FOR Rasagiline Vancombex 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 Vancombex helps to increase and sustain levels of dopamine in the brain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE VANCOMBEX DO NOT TAKE RASAGILINE VANCOMBEX: - if you are allergic (hypersensitive) 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 RASAGILINE VANCOMBEX : - 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 stoppingRasagiline Vancombex Leggi il documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rasagiline Vancombex 1 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg rasagiline (as tartrate). For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet White to off-white, round, flat tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rasagiline Vancombex 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 Vancombex 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. _ _ Page 2 of 10 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. Rasagiline is contraindicated in patients with severe hepatic impairment. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The con Leggi il documento completo