Regulatory Information
LUNDBECK SINGAPORE PTE. LTD.
LUNDBECK SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET
**4.2 Posology and method of administration** Posology Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa. It may be taken with or without food. Elderly: No change in dose is required for elderly patients. Paediatric population: AZILECT is not recommended for use in children and adolescents due to lack of data on safety and efficacy. Patients with hepatic impairment: Rasagiline use in patients with severe hepatic impairment is contraindicated (see section 4.3). Rasagiline use in patients with moderate hepatic impairment should be avoided. Caution should be used when initiating treatment with rasagiline in patients with mild hepatic impairment. In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients with renal impairment: No change in dose is required for renal impairment.
ORAL
Medical Information
**4.1 Therapeutic indications** AZILECT is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
**4.3 Contraindications** Hypersensitivity to the active substance or to any of the excipients (see section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) or pethidine (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). At least 14 days must elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine. Rasagiline is contraindicated in patients with severe hepatic impairment.
N04BD02
rasagiline
Manufacturer Information
LUNDBECK SINGAPORE PTE. LTD.
Teva Pharmaceutical Industries, Ltd.
Active Ingredients
Documents
Package Inserts
Azilect Tablet PI.pdf
Approved: March 12, 2021