Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**DOSAGE AND ADMINISTRATION** This drug is used in combination with levodopa-containing products. The usual adult dosage for oral use is 50 mg of safinamide once daily. The dosage for oral use may be administered at 100 mg once daily according to the patient’s condition. Equfina 100 mg should be tapered by decreasing the dose to 50 mg for one week before discontinuation. Precautions concerning dosage and administration 1. Co-administration with levodopa-containing products may cause adverse reactions of levodopa origin (dyskinesia, etc.). Therefore, patients should be closely monitored when the dosing of this drug is started or the dose of this drug is increased, and if such adverse reactions occur, the dose of this drug or levodopa-containing products should be adjusted. 2. The dose of Equfina should not exceed 50 mg daily for patients with moderate hepatic impairment (Child-Pugh B) \[see “PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS” and “PHARMACOKINETICS” sections – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].
ORAL
Medical Information
**INDICATIONS** Improvement of wearing-off phenomenon in idiopathic Parkinson's disease currently treated with levodopa-containing products.
**CONTRAINDICATIONS** (This drug is contraindicated in the following patients) 1. Patients using other MAO inhibitors (eg, selegiline hydrochloride, rasagiline mesilate) \[see “INTERACTIONS” section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\] 2. Patients using pethidine hydrochloride-containing products, tramadol hydrochloride-containing products, or tapentadol hydrochloride \[see “INTERACTIONS” section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\] 3. Patients using tricyclic antidepressants (eg, amitriptyline hydrochloride, amoxapine, imipramine hydrochloride, clomipramine hydrochloride, dosulepin hydrochloride, trimipramine maleate, nortriptyline hydrochloride, lofepramine hydrochloride), tetracyclic antidepressants (eg, maprotiline hydrochloride, mianserin hydrochloride, setiptiline maleate), selective serotonin reuptake inhibitors (eg, fluvoxamine maleate, paroxetine hydrochloride hydrate, sertraline hydrochloride, escitalopram oxalate), serotonin–noradrenaline reuptake inhibitors (eg, milnacipran hydrochloride, duloxetine hydrochloride, venlafaxine hydrochloride), selective noradrenaline reuptake inhibitor (atomoxetine hydrochloride), noradrenergic and serotonergic antidepressant (mirtazapine), or central nervous system stimulants (eg, methylphenidate hydrochloride, lisdexamfetamine mesilate) \[see “INTERACTIONS” section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\] 4. Patients with severe hepatic impairment (Child-Pugh C) \[see “PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS” section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\] 5. Patients with a history of hypersensitivity to any of the ingredients of this drug 6. Pregnant women or women suspected of being pregnant \[see “PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]
N04BD03
safinamide
Manufacturer Information
EISAI (SINGAPORE) PTE. LTD.
Meiji Seika Pharma Co., Ltd., Odawara Plant
Bora Pharmaceuticals Co., Ltd. (Primary packager and secondary packager)
Active Ingredients
Documents
Package Inserts
(final to HSA) Proposed Equfina PI_10Aug2022_clean.pdf
Approved: September 28, 2022