QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of viIdagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin)
Galvus® Met is indicated in the treatment of type2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Posology and method of administration
Based on the patient's current dose of metformin, Galvus® Met may be initiated at either the 50 mg/ 850 mg or 50mg/l000 mg tablet strength twice daily, one tablet in the morning and the other in the evening. The recommended daily dose is 100 mg vildagliptin plus 2000mg metformin hydrochloride.
Taking Calvus® Met with or just after food may reduce gastrointestinal symptoms associated with metformin
Paediatric population(<18 years)
Galvus® Met IS not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
-Hypersensitivity to the active substances or to any of the excipients
-Diabetic ketoacidosis or diabetic pre-coma
-Renal failure or renal dysfunction.
Special warnings and precautions for use
Galvus® Met is not a substitute for Insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Interaction with other medicinal products and other forms of interaction
Vildagliptine has a low potential for interactions with co-administration medical products.
Combinations not recommended there is increased risk of lactic acidosis in acute alcohol intoxication,due to the metformin active substance of Calvus® Met. Consumption of alcohol and medicinal products containing alcohol should be avoided.
Undesirable effects There have been no therapeutic clinical trials conducted with Calvus® Met.