Galvus Met 50/1000 mg 30 tablets
Composition
Active substances
Vildagliptin 50 mg.
Metformin hydrochloride 1000 mg.
Excipients: hydroxypropylcellulose, hypromellose, ferric oxide yellow, ferric oxide red, macrogol, magnesium stearate, talc, titanium dioxide.
Product Description
A combined hypoglycemic agent containing a dipeptidyl peptidase‑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: – as an adjunct to diet and exercise when glycemic control is insufficient; – in patients insufficiently controlled with metformin or vildagliptin monotherapy; – in patients already receiving the combination of vildagliptin and metformin as separate tablets; – in combination with other antidiabetic agents, including insulin, when they do not provide adequate glycemic control.
Method of administration and dosage
For oral use.
Take with meals to reduce gastrointestinal side effects of metformin.
Usually prescribed as one tablet of 50/1000 mg twice daily — morning and evening.
Recommended daily dose: 100 mg vildagliptin and 2000 mg metformin.
If a dose is missed — take as soon as possible, but do not double the dose on the same day.
Contraindications
Type 1 diabetes mellitus.
Diabetic ketoacidosis.
Severe renal impairment (GFR < 30 ml/min).
Metabolic acidosis, including lactic acidosis.
Hypersensitivity to the components of the drug.
Precautions
Renal function should be assessed before starting therapy and monitored regularly during treatment.
Caution in patients over 65 years of age and in those with heart failure.
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.
If treatment is required, insulin should be used.
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
Oval‑shaped, dark yellow, film‑coated tablets, engraved with “NVR” on one side and “FLO” on the other.
Cardboard box containing blisters of 30 tablets.