AVEXA AVILDAG TABLET 50MG [SIN17509P]
Active ingredients: AVEXA AVILDAG TABLET 50MG
Last updated 9 June 2026
Product Info
AVEXA AVILDAG TABLET 50MG
[SIN17509P]
Product information
Active Ingredient and Strength | VILDAGLIPTIN - 50 MG |
Dosage Form | TABLET |
Manufacturer and Country | SAG MANUFACTURING, S.L.U. - SPAIN |
Registration Number | SIN17509P |
Licence Holder | APEX PHARMA MARKETING PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A10BH02 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1. Therapeutic indications
Avildag is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as monotherapy.
Important limitations of Use
Avildag should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
Dosing
4.2. Posology and method of administration
Method of Administration
For oral use.
Avildag can be administered with or without meals (see section 5.2. Pharmacokinetic properties under Absorption – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
The 50 mg dose should be administered once daily in the morning. The 100 mg dose should be administered as two divided doses of 50 mg given in the morning and evening.
If a dose of vildagliptin is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
Dosage Regimen
The management of antidiabetic therapy should be individualized.
The recommended dose of Avildag is 50 mg once or twice daily. The maximum daily dose of Avildag is 100 mg.
Doses higher than 100 mg are not recommended.
General target population
Adults 18 years of age and above.
Specific populations
Renal impairment
No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/min). In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD) on haemodialysis, the recommended dose of vildagliptin is 50 mg once daily (see section 5.2. Pharmacokinetic properties under Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Hepatic impairment
Vildagliptin should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5x the upper limit of normal (ULN) (see section 5.2. Pharmacokinetic properties under Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Geriatric patients (65 years or above)
No dose adjustments are necessary in elderly patients (see section 5.2. Pharmacokinetic properties under Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric patients (below 18 years)
The use of vildagliptin s is not recommended for use in children below 18 years (see section 5.2. Pharmacokinetic properties under Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Contraindications
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients of the formulation (see section 6.1 List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).