MADOPAR

Country: Indonesia

Bahasa: Indonesia

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

Bahan aktif:

BENSERAZIDE HYDROCHLORIDE; LEVODOPA

Boleh didapati daripada:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (Nama Antarabangsa):

BENSERAZIDE HYDROCHLORIDE; LEVODOPA

Dos:

100/25 MG

Borang farmaseutikal:

TABLET DISPERSIBLE

Unit dalam pakej:

DUS, BOTOL @ 30 TABLET DISPERSIBLE

Dikeluarkan oleh:

F. HOFFMANN LA ROCHE LTD

Tarikh kebenaran:

2019-01-22

Ciri produk

_Draft_Madopar_PI_Safety update_CDS8.0_EN_v3.0_
_Page 1 of 13_
MADOPAR
®
Levodopa + Bensirazide
1. DESCRIPTION
1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
ATC code: N04BA02
Madopar is a combination of levodopa and the decarboxylase inhibitor
benserazide.
1.2 TYPE OF DOSAGE FORM
_Dispersible form:_
Single-scored dispersible tablets as Madopar ‘125’.
1.3 ROUTE OF ADMINISTRATION
Oral.
1.4 STERILE/RADIOACTIVE COMPOSITION
Not applicable.
1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
Madopar is a combination of levodopa and the decarboxylase inhibitor
benserazide (as hydrochloride) in
a ratio of 4:1. The following strength is available: Madopar
‘125’=levodopa 100 mg + benserazide 25 mg.
Excipients: citric acid (anhydrous), pregelatinised starch (maize),
microcrystalline cellulose, magnesium
stearate.
2. CLINICAL PARTICULARS
2.1 THERAPEUTIC INDICATIONS
Madopar is indicated in the treatment of Parkinson’s disease,
symptomatic parkinsonism postencephalitic,
except drug-induced parkinsonism syndromes.
Madopar dispersible is a formulation which is suitable for patients
with dysphagia (difficulties in
swallowing) or who require a formulation with a more rapid onset of
action, e.g. patients suffering from
early morning and afternoon akinesia, or who exhibit “delayed on”
or “wearing off” phenomena.
2.2 DOSAGE AND ADMINISTRATION
Where possible, Madopar should be taken 30 min before or one hour
after meals where possible so that
the competitive effect of dietary protein on levodopa uptake can be
avoided (see section
_2.8 Interactions_
_with Other Medicinal Products and Other Forms of Interaction_
) and to facilitate a more rapid onset of
action. Undesirable gastrointestinal effects, which may occur mainly
in the early stages of the treatment,
can largely be controlled by taking Madopar with a low protein snack
(e.g. biscuits) or liquid or by
increasing the dose slowly.
DISETUJUI OLEH BPOM: 21/07/2021
ID REG: EREG10036412000463
_Draft_Madopar_PI_Safety update_CDS8.0_EN_v3.0_
_Page 2 of 13_
_M