Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
ROPINIROLE
Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom
N04BC04
ROPINIROLE 0.25 mg
FILM-COATED TABLET
ROPINIROLE 0.25 mg
POM
ANTI-PARKINSON DRUGS
Withdrawn
2011-02-21
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER ROPINIROLE 0.25MG, 0.5MG, 1MG AND 2MG FILM-COATED TABLETS ROPINIROLE HYDROCHLORIDE (REFERRED TO AS ROPINIROLE TABLETS IN THE REMAINDER OF THE LEAFLET) 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, please 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 side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Ropinirole Tablets are and what they are used for 2. What you need to know before you take Ropinirole Tablets 3. How to take Ropinirole Tablets 4. Possible side effects 5. How to store Ropinirole Tablets 6. Contents of the pack and other information 1. WHAT ROPINIROLE TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient in Ropinirole Tablets is ropinirole which belongs to a group of medicines called dopamine agonists. Dopamine agonists affect the brain in a similar way to a natural substance called dopamine. Ropinirole Tablets are used to treat: • Parkinson’s disease. People with Parkinson’s disease have low levels of dopamine in some parts of their brains. Ropinirole has effects similar to those of natural dopamine, so it helps to reduce the symptoms of Parkinson’s disease. • moderate to severe Restless Legs Syndrome. People with Restless Legs Syndrome have an irresistible urge to move their legs, and sometimes their arms and other parts of their body. Usually, they have unpleasant sensations in their limbs – sometimes described as ‘crawling’ or ‘bubbling’ – which can begin as soon as they sit or lie down, and are relieved only by movement. So they often have problems with sitting still, and especially with sle Lue koko asiakirja
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ropinirole 0.25mg Film-Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 0.285mg ropinirole hydrochloride, equivalent to 0.25mg ropinirole. Excipient(s) with known effect Lactose monohydrate – 118.6mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, irregular hexagonal shape film-coated tablets, debossed with ‘W’ on one side and ‘154’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Parkinson's Disease under the following conditions: _ _ - Initial treatment as monotherapy, in order to delay the introduction of levodopa. - In combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations in the therapeutic effect occur (“end of dose” or “on-off” type fluctuations). Ropinirole is also indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology TREATMENT OF IDIOPATHIC PARKINSON’S DISEASE Adults Individual dose titration against efficacy and tolerability is recommended. Ropinirole should be taken three times a day, preferably with meals to improve gastrointestinal tolerance. Page 2 of 13 _TREATMENT INITIATION: _ The initial dose of ropinirole should be 0.25 mg three times daily for one week. Thereafter, the dose of ropinirole can be increased in 0.25mg three times daily increments, according to the following regimen: _ _ Week 1 2 3 4 Unit dose (mg) of ropinirole 0.25 0.5 0.75 1.0 Total daily dose (mg) of ropinirole 0.75 1.5 2.25 3.0 _THERAPEUTIC REGIMEN_ : After the initial titration, weekly increments of 0.5 to 1mg three times daily (1.5 to 3mg/day) of ropinirole _ _ may be given. _ _ A therapeutic response may be seen between 3 and 9 mg/day of ropinirole. If sufficient symptomatic control is not achieved, or maint Lue koko asiakirja