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HSA Product

MADOPAR 250 TABLET 250 mg

Product approved by Health Sciences Authority (SG)

Basic Information

MADOPAR 250 TABLET 250 mg

TABLET

Regulatory Information

SIN06119P

May 17, 1991

Prescription Only

Therapeutic

ORAL

August 10, 2023

June 4, 2025

XN04BA02

Company Information

ROCHE SINGAPORE PTE. LTD.

ROCHE SINGAPORE PTE. LTD.

Active Ingredients

Detailed Information

Contraindications

**2.3. Contraindications** Madopar is contraindicated in: - patients with known hypersensitivity to levodopa or benserazide or any of the excipients. - patients receiving non-selective monoamine oxidase (MAO) inhibitors due to the risk of hypertensive crisis (see section 2.4.1 Warnings and Precautions, General – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). However, selective MAO-B inhibitors, such as selegiline and rasagiline or selective MAO-A inhibitors, such as moclobemide, are not contraindicated. Combination of MAO-A and MAO-B inhibitors is equivalent to non-selective MAO inhibition, and hence this combination should not be given concomitantly with Madopar (see section 2.8 Interactions with other Medicinal Products and other Forms of Interaction – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - patients with decompensated endocrine, renal or hepatic function, cardiac disorders, psychiatric diseases with a psychotic component or closed angle glaucoma. - patients less than 25 years old (skeletal development must be complete). - pregnant women or women of childbearing potential in the absence of adequate contraception (see 2.5.2 Pregnancy and 2.5.3 Lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If pregnancy occurs in a woman taking Madopar, the drug must be discontinued (as advised by the prescribing physician).

Indication Information

**2.1. Therapeutic Indications** _Parkinson’s disease:_ Madopar is indicated for the treatment of Parkinson’s disease with the exception of drug-induced Parkinsonism. 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’ phenomenon. Madopar HBS is indicated for patients presenting with all types of fluctuations (i.e. ‘peak dose dyskinesia’ and ‘end of dose deterioration’ – such as nocturnal immobility).

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