REQUIP PD 24 HOUR

Kraj: Indonezja

Język: indonezyjski

Źródło: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Składnik aktywny:

ROPINIROLE HYDROCHLORIDE

Dostępny od:

GLAXO WELLCOME INDONESIA - Indonesia

INN (International Nazwa):

ROPINIROLE HYDROCHLORIDE

Dawkowanie:

2 MG

Forma farmaceutyczna:

TABLET PELEPASAN LAMBAT

Sztuk w opakowaniu:

DUS, 7 BLISTER @ 4 TABLET PELEPASAN LAMBAT

Wyprodukowano przez:

GLAXO WELLCOME SA - Spain

Data autoryzacji:

2017-09-11

Charakterystyka produktu

AWB_leaREQ_PI Update to GDS36IPI24_circ1_18Mar21
ERS_leaREQ_PI Update to GDS35IPI23_circ2_9Feb21
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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