Vildagluse Plus 50/1000 mg 30 tablets
Composition
Vildagliptin 50 mg.
Metformin hydrochloride 1000 mg.
Excipients: hypromellose, magnesium stearate, sodium carboxymethylcellulose, colloidal silicon dioxide, film coating (Opadry yellow, talc).
Product Description
A combined hypoglycemic agent containing a DPP‑4 inhibitor (vildagliptin) and a biguanide (metformin).
Provides a dual mechanism of glycemic control: stimulates insulin secretion and reduces hepatic glucose production.
Indications for use
Used in adult patients with type 2 diabetes mellitus: in cases of insufficient glycemic control on the maximum dose of metformin;
when switching from separate administration of vildagliptin and metformin;
as part of triple therapy with sulfonylurea derivatives or insulin.
Method of administration and dosage
Usually prescribed as one tablet of 50/1000 mg twice daily — in the morning and evening, with meals.
The maximum daily dose of vildagliptin is 100 mg.
Dosage is adjusted individually depending on tolerability and glycemic level.
Contraindications
Hypersensitivity to the components of the drug.
Diabetic ketoacidosis, diabetic coma.
Severe renal impairment (GFR < 30 ml/min).
Metabolic acidosis, including lactic acidosis.
Alcoholism.
Precautions
Renal function should be assessed before starting therapy and monitored regularly during treatment.
Caution in patients with heart failure and in those over 65 years of age.
Risk of lactic acidosis in cases of impaired renal function or alcohol abuse.
Adverse reactions / Side effects
Most common: nausea, diarrhea, abdominal pain, headache, dizziness.
Possible hypoglycemia (especially in combination with sulfonylurea), elevated liver enzymes, skin reactions, weakness.
Pregnancy and lactation
Contraindicated.
The safety of vildagliptin and metformin during pregnancy and breastfeeding has not been established.
Insulin should be used if treatment is required.
Storage conditions
Store at a temperature not exceeding +25 °C, in the original packaging, protected from moisture and light.
Keep out of the reach of children.
Packaging
Cardboard box containing blisters with film‑coated oval tablets, yellow‑brown in color, with a score line for ease of swallowing.
Pack of 30 tablets.