This tablet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus whose diabetes is not adequately controlled on metformin hydrochloride or Reclevus alone, or in patients already treated with the combination of Reclevus and metformin hydrochloride as separate tablets.

Vildagliptin acts by inhibiting dipeptidyl peptidase-4 (DPP-4), the enzyme responsible for the breakdown of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). DPP-4 inhibition leads to increased fasting and postprandial levels of these incretin hormones.

By increasing endogenous incretin levels, vildagliptin enhances insulin secretion from pancreatic beta cells and reduces glucagon secretion from alpha cells. This improves the insulin-to-glucagon ratio during hyperglycaemia, leading to reduced hepatic glucose production and lower blood glucose levels both fasting and postprandial. Metformin hydrochloride is a biguanide oral antihyperglycaemic agent used in type 2 diabetes management. It lowers both basal and postprandial plasma glucose levels. Unlike sulfonylureas, it does not cause hypoglycaemia. Metformin reduces hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Adults: Based on the patient's current dose of Metformin, this combination may be initiated at twice daily, 1 tablet in the morning and the other in the evening. Patients receiving Vildagliptin and Metformin from separate tablets may be switched to this combination containing the same doses of each component. Doses higher than 100 mg of vildagliptin are not recommended. There is no clinical experience of Vildagliptin and Metformin in triple combination with other antidiabetic agents. Taking this combination with or just after food may reduce gastrointestinal symptoms associated with Metformin.

This combination is contraindicated in patients with known hypersensitivity to vildagliptin, metformin hydrochloride, or any excipients. It is also contraindicated in patients with renal disease or renal dysfunction, acute myocardial infarction, septicemia, congestive heart failure, and acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. It should be temporarily discontinued in patients undergoing radiologic studies involving intravascular iodinated contrast agents due to risk of acute renal impairment.

Most common side effects include headache, tremor, dizziness, nausea, and hypoglycaemia

There are no adequate and well-controlled studies in pregnant women. Therefore, this combination should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether vildagliptin or metformin is excreted in human breast milk; therefore, this combination should not be used during breastfeeding.

Lactic acidosis may occur due to metformin accumulation. If suspected, treatment should be discontinued immediately and the patient hospitalized. Serum creatinine should be monitored at least once yearly in normal renal function and 2–4 times yearly in elderly or high-risk patients. Use caution in elderly patients, especially when starting antihypertensives, diuretics, or NSAIDs, due to possible renal impairment. Liver function tests (LFTs) should be done before starting treatment, every 3 months in the first year, and periodically thereafter. If transaminases increase, repeat testing is required. If AST or ALT persist >3× ULN, treatment should be stopped. Patients with jaundice or liver dysfunction should discontinue the drug and not restart after normalization. The combination should be stopped 48 hours before elective surgery under general anesthesia and restarted no earlier than 48 hours after.

Pediatric use: Safety and effectiveness have not been established. Not recommended for patients under 18 years.

Geriatric use: Elderly patients should have regular renal function monitoring. Use only if renal function is normal.

Renal impairment: Contraindicated in renal failure or dysfunction (serum creatinine >1.5 mg/dL in males and >1.4 mg/dL in females).

Hepatic impairment: Not recommended in patients with hepatic impairment or ALT/AST >3× ULN.

Combination oral hypoglycaemic preparations

Keep in a dry place, away from light and heat. Keep out of reach of children.