Information about Noveldo
Composition:

Each Noveldo tablet contains 50 mg vildagliptin.

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 with one of metformin, a sulfonylurea or pioglitazone when diet, exercise and the single agent do not result in adequate glycaemic control.

Contraindications:

Hypersensitivity to vildagliptin or to any of the excipients.

Adverse Reactions:

The majority of adverse reactions in these trials were mild and transient, not requiring treatment discontinuations. No association was found between adverse reactions and age, gender, ethnicity, duration of exposure or daily dose.

Dosage and Administration:

- The management of antidiabetic therapy should be individualised.

-  Use with combination with:

-  metformin, a thiazolidinedione: Noveldo 50 mg or 100 mg daily. (50 mg once daily in the morning, 100 mg should be administered as two divided doses of 50 mg given in the morning and evening).

-  Use with combination with a sulphonylurea: Noveldo 50 mg once daily in the morning.

In this patient population, Noveldo 100mg daily was no more effective than the 50mg once daily and was associated with a higher rate of hypoglycaemia than the 50mg dose.

-  Doses greater than 100 mg are not recommended.

-  Noveldo can be administered with or without a meal.

Packing:

Noveldo is available in blisters packs of: 14 tablets of 50 mg vildagliptin