MedPath
HSA Product

Stalevo Film Coated Tablets 150/37.5/200 mg

Product approved by Health Sciences Authority (SG)

Basic Information

Stalevo Film Coated Tablets 150/37.5/200 mg

TABLET, FILM COATED

Regulatory Information

SIN13141P

August 29, 2005

Prescription Only

Therapeutic

ORAL

August 10, 2023

May 30, 2025

Company Information

ORION PHARMA (SG) PTE. LTD.

ORION PHARMA (SG) PTE. LTD.

Active Ingredients

Levodopa

Strength: 150 mg

Entacapone

Strength: 200 mg

Detailed Information

Contraindications

**CONTRAINDICATIONS** - Known hypersensitivity to the active substances or to any of the excipients. - Liver impairment. - Narrow-angle glaucoma. - Pheochromocytoma. - Co-administration of a non-selective monoamine oxidase (MAO-A and MAO-B) inhibitor (e.g. phenelzine, tranylcypromine). - Co-administration use of a selective MAO-A inhibitor and a selective MAO-B inhibitor (see section INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS, other antiparkinsonian medicinal products – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). These inhibitors must be discontinued at least two weeks prior to initiating therapy with Stalevo. - A history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis. - Because levodopa may activate malignant melanoma, Stalevo should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma.

Indication Information

**THERAPEUTIC INDICATIONS** Stalevo is indicated for the treatment of patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.

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