Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: myHealthbox
rasagiline
Caduceus Pharma Ltd
N04BD02
rasagiline
1mg
Tablets
Oral use
28 tablets
POM - Prescription Only Medicine
Actavis ehf
Anti-Parkinson-Drugs, Monoamine oxidase -B inhibitors
It 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.
Authorised
2015-08-20
Rasagiline 1mg 28 Tablets PIL - UK item no: AAAI0886 print proof no: 4 origination date: 24.06.15 originated by: S.Anson revision date: 26.06.15 revised by: BW dimensions: 170 x 440 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: 24.06.15 supplier: Actavis Iceland technically app. date: min pt size: 9pt TECHNICAL APPROVAL RASAGILINE 1MG TABLETS Rasagiline tartrate 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. • The full name of this medicine is Rasagiline 1mg Tablets but within the leaflet it will be referred to as Rasagiline Tablets. WHAT IS IN THIS LEAFLET 1 WHAT RASAGILINE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE TABLETS 3 HOW TO TAKE RASAGILINE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE RASAGILINE TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT RASAGILINE TABLETS ARE AND WHAT THEY ARE USED FOR Rasagiline Tablets are 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 Tablets helps to increase and sustain levels of d Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rasagiline 1mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg rasagiline (as tartrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round bevel edge, debossed with “A486” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rasagiline Tablets 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 Tablets 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) o Izlasiet visu dokumentu