SIFROL ER

Nazione: Indonesia

Lingua: indonesiano

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

Principio attivo:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Commercializzato da:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (Nome Internazionale):

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Dosaggio:

0,75 Mg

Forma farmaceutica:

TABLET PELEPASAN LAMBAT

Confezione:

DUS, 3 ALUBLISTER @ 10 TABLET PELEPASAN LAMBAT

Prodotto da:

ROTTENDORF PHARMA GMBH - Federal Republic of Germany

Data dell'autorizzazione:

2021-08-04

Scheda tecnica

PT. Boehringer Ingelheim Indonesia
Medical and Regulatory Affairs
SIFROL ER, Rottendorf
SIFROL
®
PRAMIPEXOLE
COMPOSITION
1 EXTENDED-RELEASE TABLET CONTAINS 0.375, 0.75 MG
(S)-2-AMINO-4,5,6,7-TETRAHYDRO-6-PROPYLAMINO-BENZOTHIAZOLE
DIHYDROCHLORIDE MONOHYDRATE EQUIVALENT
TO 0.26, 0.52 MG PRAMIPEXOLE BASE.
Excipients**: hypromellose 2208, maize starch, carbomer 941, colloidal
anhydrous silica, magnesium stearate
INDICATION/USAGE
SIFROL
®
tablets and Extended-release tablets are indicated for the treatment
of the signs and symptoms of
idiopathic Parkinson’s disease when the effect of levodopa wears off
or becomes inconsistent and fluctuations
of the therapeutic effect occur (end of dose “on off”
fluctuations). It may be used alone (without levodopa) or
in combination with levodopa.
SIFROL
®
tablets are indicated for the symptomatic treatment of idiopathic
Restless Legs Syndrome.
DOSAGE AND ADMINISTRATION
_(All dose information refers to pramipexole salt form) _
PARKINSON ’S DISEASE
Dosage
Initial treatment
As shown below dosages should be increased gradually from a starting
dose of 0.375 mg per day and then
increased every 5 - 7 days. Providing patients do not experience
intolerable side effects, the dosage should be
titrated to achieve a maximal therapeutic effect.
ASCENDING-DOSE SCHEDULE OF SIFROL
®
_week _
_total daily _
_dose (mg) _
_tablets (mg) _
_Extended-release _
_tablets (mg) _
1
0.375
3 x 0.125
_0.375 _
2
0.75
3 x 0.25
_0.75 _
3
1.50
3 x 0.5
_1.50 _
If a further dose increase is necessary the daily dose should be
increased by 0.75 mg at weekly intervals up to
a maximum dose of 4.5 mg per day.
Patients already taking SIFROL
®
tablets may be switched to SIFROL
®
prolonged-release tablets overnight, at
the same daily dose.
Maintenance treatment:
The individual dose should be in the range of 0.375 mg to a maximum of
4.5 mg per day. During dose escalation
in pivotal studies both in early and advanced disease efficacy was
observed starting at a daily dose of 1.5 mg.
This does not preclude that in in