国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
ROPINIROLE HYDROCHLORIDE
GlaxoSmithKline (Ireland) Limited
ROPINIROLE HYDROCHLORIDE
0.50 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2010-12-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ADARTREL 0.5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.5 mg of ropinirole (as hydrochloride). Excipient: 45.0 mg lactose (as monohydrate) Excipient(s): Contains Lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow pentagonal-shaped, bevelled edge tablets marked "SB" on one side and "4891" 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. _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, was 2 mg once a day. The dose may be increased to 1 mg once a day at week 2. The dose may then be increased by 0.5 mg per week over the next two weeks to a dose of 2 mg once a day. In some patients, to achieve optimal improvement, the dose may be increased gradually up to a maximum of 4 mg once a day. In clinical trials t 完全なドキュメントを読む