Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Rasagiline
Rowex Ltd
N04BD; N04BD02
Rasagiline
1 milligram(s)
Tablet
oral use
10, 28, 30, 98, 100, 112 tablets
Product subject to prescription which may be renewed (B)
Delorbis Pharmaceuticals Ltd
anti-parkinson drugs, monoamine oxidase B inhibitors
Monoamine oxidase B inhibitors; rasagiline
Rasagiline Rowex 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
Marketed
2015-11-27
PACKAGE LEAFLET: INFORMATION FOR THE USER RASAGILINE ROWEX 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 Rowex is and what it is used for 2. What you need to know before you take Rasagiline Rowex 3. How to take Rasagiline Rowex 4. Possible side effects 5. How to store Rasagiline Rowex 6. Contents of the pack and other information 1. WHAT RASAGILINE ROWEX IS AND WHAT IT IS USED FOR Rasagiline Rowex 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. Rasagiline Rowex helps to increase and sustain levels of dopamine in the brain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE ROWEX DO NOT TAKE RASAGILINE ROWEX - 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 Rasagiline Rowex: - 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 Rowex treatment an Baca dokumen lengkapnya
Health Products Regulatory Authority 25 May 2022 CRN00CVR2 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rasagiline Rowex 1 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg of rasagiline (as rasagiline tartrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, round, flat, bevelled tablets (6.5 mm). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rasagiline Rowexis indicated in adults for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) inpatients with end of dose fluctuations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of rasagiline is1mg (one tablet of Rasagiline Rowex) 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 inpatients 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 Rasagiline Rowex in children and adolescents have not been established. There is no relevant use of Rasagiline Rowex in the paediatric population in the indication Parkinson’s disease. Method of administration For oral use. Rasagiline Rowex may be taken with or without food. 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) orpeth Baca dokumen lengkapnya