Country: Малта
Језик: Енглески
Извор: Medicines Authority
ROPINIROLE
GlaxoSmithKline Consumer Health-care UK Trading Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
N04BC04
ROPINIROLE 0.25 mg
FILM-COATED TABLET
ROPINIROLE 0.25 mg
POM
ANTI-PARKINSON DRUGS
Withdrawn
2006-07-27
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER ADARTREL ® (LOGO) 0.25 MG, 0.5 MG, 2 MG FILM-COATED TABLETS ROPINIROLE (AS HYDROCHLORIDE) _(banner heading at right angles to rest of leaflet) _ ------------------------------------------------------------------------------------------------------------------------ -------- ADARTREL ® (LOGO) FILM-COATED TABLETS ROPINIROLE 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. 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 OF THE 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 ADARTREL IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADARTREL 3 HOW TO TAKE ADARTREL 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ADARTREL 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT ADARTREL IS AND WHAT IT IS USED FOR The active ingredient in Adartrel is ropinirole, which belongs to a group of medicines called DOPAMINE AGONISTS. Dopamine agonists act in a similar way to a natural substance called dopamine, in the brain. ADARTREL IS USED TO TREAT THE SYMPTOMS OF MODERATE TO SEVERE RESTLESS LEGS SYNDROME. Restless legs syndrome (RLS) is also called Ekbom syndrome. People with restless legs syndrome have an irresistible urge to move their legs, and sometimes their arms and other parts of their bodies. 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 sleeping. Adartrel relieves the unpleasant sensations, and so reduces the urge to move the legs an Прочитајте комплетан документ
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ADARTREL 0.25 mg film-coated tablets. ADARTREL 0.5 mg film-coated tablets. ADARTREL 2 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.25 mg of ropinirole (as hydrochloride). Excipient: 45.3 mg lactose (as monohydrate) Each film-coated tablet contains 0.5 mg of ropinirole (as hydrochloride). Excipient: 45.0 mg lactose (as monohydrate) Each film-coated tablet contains 2 mg of ropinirole (as hydrochloride). Excipient: 44.6 mg lactose (as monohydrate) Excipient(s) with known effect Contains Lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 0.25 mg : White pentagonal-shaped, bevelled edge tablets, marked "SB" on one side and "4890" on the other. 0.5 mg : Yellow pentagonal-shaped, bevelled edge tablets, marked "SB" on one side and "4891" on the other. 2 mg : Pink pentagonal-shaped, bevelled edge tablets, marked "SB" on one side and "4893" on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADARTREL is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. Adults Individual dose titration against efficacy and tolerability is recommended. Ropinirole should be taken just before bedtime, however the dose can be taken up to 3 hours before retiring. Ropinirole may be taken with food, to improve gastrointestinal tolerance. Page 2 of 12 _Treatment initiation (week 1) _ The recommended initial dose is 0.25 mg once daily (administered as above) for 2 days. If this dose is well tolerated the dose should be increased to 0.5 mg once daily for the remainder of week 1. _Therapeutic regimen (week 2 onwards) _ Following treatment initiation, the daily dose should be increased until optimal therapeutic response is achieved. The average dose in clinical trials, in patients with moderate to severe Restless Legs Syndrome Прочитајте комплетан документ