Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
rotigotine
UCB Pharma S.A.
N04BC09
rotigotine
Anti-Parkinson drugs
Restless Legs Syndrome; Parkinson Disease
Parkinson's disease: Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations).Restless-legs syndrome: Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.
Revision: 31
Authorised
2006-02-15
124 B. PACKAGE LEAFLET 125 PACKAGE LEAFLET: INFORMATION FOR THE USER NEUPRO 1 MG/24 H TRANSDERMAL PATCH NEUPRO 3 MG/24 H TRANSDERMAL PATCH Rotigotine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or nurse. • 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Neupro is and what it is used for 2. What you need to know before you use Neupro 3. How to use Neupro 4. Possible side effects 5. How to store Neupro 6. Contents of the pack and other information 1. WHAT NEUPRO IS AND WHAT IT IS USED FOR WHAT NEUPRO IS Neupro contains the active substance rotigotine. It belongs to a group of medicines called ‘dopamine agonists’. Dopamine is a messenger in the brain which is important for movement. WHAT NEUPRO IS USED FOR Neupro is used in adults to treat the signs and symptoms of: • RESTLESS LEGS SYNDROME (RLS) – this can be associated with discomfort in your legs or arms, urges to move around, sleep disturbance and feeling tired or sleepy during the day. These symptoms are either reduced or their duration is shortened with Neupro treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NEUPRO DO NOT USE NEUPRO IF: • you are ALLERGIC to ROTIGOTINE or any of the OTHER INGREDIENTS of this medicine (listed in section 6) • you need to have a MAGNETIC RESONANCE IMAGING (MRI) scan (diagnostic pictures of the inside of the body, created using magnetic rather than x-ray energy) • you need ‘ CARDIOVERSION ’ (specific treatment for abnormal heart beat). You must take your Neupro patch off just before undergoing magnetic resonance imaging (MR Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Neupro 1 mg/24 h transdermal patch Neupro 3 mg/24 h transdermal patch 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Neupro 1 mg/24 h transdermal patch Each patch releases 1 mg of rotigotine per 24 hours. Each patch of 5 cm 2 contains 2.25 mg of rotigotine. Neupro 3 mg/24 h transdermal patch Each patch releases 3 mg of rotigotine per 24 hours. Each patch of 15 cm 2 contains 6.75 mg of rotigotine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transdermal patch. Thin, matrix-type, square-shaped with rounded edges, consisting of three layers. Neupro 1 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 1 mg/24 h’. Neupro 3 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 3 mg/24 h’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose recommendations made are in nominal dose. A single daily dose should be initiated at 1 mg/24 h. Depending on the individual patient response, the dose may be increased in weekly increments of 1 mg/24 h to a maximum dose of 3 mg/24 h. The need for treatment continuation should be reconsidered every 6 months. Neupro is applied once a day. The patch should be applied at approximately the same time every day. The patch remains on the skin for 24 hours and will then be replaced by a new one at a different site of application. If the patient forgets to apply the patch at the usual time of the day or if the patch becomes detached, another patch should be applied for the remainder of the day. 3 _Treatment discontinuation _ Neupro should be discontinued gradually. The daily dose should be reduced in steps of 1 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Neupro (s Izlasiet visu dokumentu