Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
rotigotine
UCB Pharma S.A.
N04BC09
rotigotine
Anti-Parkinson drugs
Restless Legs Syndrome; Parkinson Disease
Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.Leganto 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).
Revision: 19
Withdrawn
2011-06-16
125 B. PACKAGE LEAFLET Medicinal product no longer authorised 126 PACKAGE LEAFLET: INFORMATION FOR THE USER LEGANTO 1 MG/24 H TRANSDERMAL PATCH LEGANTO 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 Leganto is and what it is used for 2. What you need to know before you use Leganto 3. How to use Leganto 4. Possible side effects 5. How to store Leganto 6. Contents of the pack and other information 1. WHAT LEGANTO IS AND WHAT IT IS USED FOR WHAT LEGANTO IS Leganto 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 LEGANTO IS USED FOR Leganto 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 Leganto treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LEGANTO DO NOT USE LEGANTO 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 Leganto patch off just Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Leganto 1 mg/24 h transdermal patch Leganto 3 mg/24 h transdermal patch 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Leganto 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. Leganto 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. Leganto 1 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 1 mg/24 h’. Leganto 3 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 3 mg/24 h’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Leganto 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. Leganto 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. Medicinal product no longer authorised 3 _Treatment discontinuation _ Leganto should be discontinued gradually. The daily dose should be reduced in steps of 1 mg/24 h Pročitajte cijeli dokument