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AZILECT TABLET 1MG [SIN15291P]
Active ingredients: AZILECT TABLET 1MG
Last updated 26 October 2025
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Product Info
AZILECT TABLET 1MG
[SIN15291P]
Product information
Active Ingredient and Strength | RASAGILINE MESYLATE 1.56 MG EQUIVALENT RASAGILINE - 1 MG |
Dosage Form | TABLET |
Manufacturer and Country | TEVA PHARMACEUTICAL INDUSTRIES, LTD. - ISRAEL |
Registration Number | SIN15291P |
Licence Holder | LUNDBECK SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | N04BD02 |
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.
4.2 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.
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.