Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ROPINIROLE HYDROCHLORIDE
GLAXO WELLCOME INDONESIA - Indonesia
ROPINIROLE HYDROCHLORIDE
2 MG
TABLET PELEPASAN LAMBAT
DUS, 7 BLISTER @ 4 TABLET PELEPASAN LAMBAT
GLAXO WELLCOME SA - Spain
2017-09-11
AWB_leaREQ_PI Update to GDS36IPI24_circ1_18Mar21 ERS_leaREQ_PI Update to GDS35IPI23_circ2_9Feb21 Page 1 of 9 REQUIP PD 24 HOUR ROPINIROLE PROLONGED RELEASE TABLETS 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release tablet contains ropinirole hydrochloride equivalent to 2, 4 or 8 mg ropinirole free base. 2. CLINICAL INFORMATION 2.1 INDICATIONS _REQUIP PD 24 HOUR _may be used as: - Monotherapy, alone (without levadopa) in idiopathic Parkinson’s disease or - As adjunctive therapy in addition to levadopa to control “on-off” fluctuations which might permit a reduction in the total daily dose of levadopa. 2.2 DOSAGE AND ADMINISTRATION PHARMACEUTICAL FORM Film-coated, capsule-shaped tablets for oral administration. The tablet strengths are distinguished by colour and debossing; 2 mg: pink, capsule-shaped, film-coated tablets marked “GS” on one side and “3V2” on the other. 4 mg: light brown, capsule-shaped, film-coated tablets marked “GS” on one side and “WXG” on the other. 8 mg: red, capsule-shaped, film-coated tablets marked “GS” on one side and “5CC” on the other. When switching treatment from another dopamine agonist to _REQUIP PD 24 HOUR_, the manufacturer’s guidance on discontinuation should be followed before initiating _REQUIP PD 24 HOUR_. Individual dose titration against efficacy and tolerability is recommended. Patients should be down-titrated if they experience disabling somnolence at any dose level. For other adverse events, down-titration followed by more gradual up-titration has been shown to be beneficial. ADULTS _REQUIP PD 24 HOUR _should be taken as a single daily dose and should be taken at a similar time each day. The tablet(s) must be swallowed whole, and must not be chewed, crushed or divided. _REQUIP PD 24 _ _HOUR _may be taken with or without food (_see Pharmacokinetics_). - TREATMENT INITIATION The dose should be titrated according to the individual clinical response. The recommended initial dose is 2 mg once daily for one week. A guide for the titr Preberite celoten dokument