1. NAME OF THE MEDICINE: The active ingredient of VILDIET is vildagliptin.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Vildagliptin is a white to slightly yellowish or slightly greyish crystalline powder with a melting point range of approximately 150°C.
It is freely soluble in water.
Each VILDIET tablet contains 50 mg vildagliptin,
Excipients with known effect: lactose
3. PHARMACEUTICAL FORM VILDIET available as a 50 mg tabletof Vidagliptin.
3.1 PHARMACEUTICAL FORM VILDIET-M available as a 50 mgVidagliptin with 500/1000 mg Metformin tablet.
White to light yellowish, round flat-faced with bevelled edges, unscored tablet.

4.CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS : Treatment of diabetes mellitus type 2 in persons 18 years of age and older, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes:
• As monotherapy, in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
• In dual combination with one of metformin, a sulfonylurea or pioglitazone when diet, exercise and the single agent do not result in adequate glycaemic control.
• In triple combination with a sulfonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.
• In combination with insulin (with or without metformin) when diet, exercise and a stable dose of insulin do not result in adequate glycaemic control.4.CLINICAL PARTICULARS

4.2 DOSE AND METHOD OF ADMINISTRATION : The management of antidiabetic therapy should be individualised.
Doses greater than 100 mg are not recommended.
VILDIET can be administered orally with or without a meal.
The 50 mg dose should be administered once daily in the morning. The 100 mg daily dose should be administered as two divided doses of 50 mg taken in the morning and evening.
If a dose VILDIET is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
As monotherapyThe recommended dose of VILDIET 50 mg twice daily (100 mg daily dose) for monotherapy.
In dual combination therapy, When used in dual combination with metformin or a thiazolidinedione (clinical experience is with pioglitazone as dual therapy), the recommended dose of VILDIET is 50 mg once daily or 100 mg (50 mg twice) daily.
When used in dual combination with a sulfonylurea (clinical experience is with glimepiride as dual therapy), the recommended dose of VILDIET is 50 mg once daily administered in the morning. In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily and was associated with a higher rate of hypoglycaemia than the 50 mg dose.
In combination with insulin The recommended dose of VILDIET is 50 mg once daily or 100 mg (50 mg twice) daily in combination with insulin (with or without metformin).
In triple combination therapy The recommended dose of VILDIET is 100mg daily (50 mg twice a day) for triple combination with metformin and a sulfonylurea.
Patients with hepatic impairment Vildagliptin is not recommended. In patients with hepatic impairment including patients with a pre-treatment ALT or AST > 2.5x the ULN.
Patients with renal impairment Glomerular Filtration Rate (GFR) is to be estimated prior to commencement of therapy.
Paediatric patients Vildagliptin has not been studied in patients under 18 years of age; therefore, the use of vildagliptin in paediatric patients is not recommended (see Section 5.2 Pharmacokinetic properties, Special Populations).