Land: Indonesia
Språk: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BENSERAZIDE HYDROCHLORIDE, LEVODOPA
BOEHRINGER INGELHEIM INDONESIA - Indonesia
BENSERAZIDE HYDROCHLORIDE, LEVODOPA
28.5 MG /100 MG
TABLET DISPERSIBLE
DUS, BOTOL @ 30 TABLET DISPERSIBLE
DELPHARM MILANO S.R.L - Italy
2019-04-26
_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 Les hele dokumentet