Mellitofix Met 12,5/1000 mg

Trade Name:

Mellitofix Met

Composition

Each tablet contains:

Empagliflozin 12.5 mg

Metformin hydrochloride 1000 mg

Inactive ingredients:

Starch, copovidone, magnesium stearate.

Properties

Mellitofix Met combines two hypoglycemic drugs designed to improve glycemic control in patients with type 2 diabetes mellitus, the mechanism of action of which complements each other: empagliflozin, an inhibitor of sodium glucose cotransporter 2 (SGLT2), and metformin hydrochloride. representative of the biguanide class.

Empagliflozin improves glycemic control in patients with type 2 diabetes mellitus by reducing the reabsorption of glucose by the kidneys. The amount of glucose excreted by the kidneys through this glucuretic mechanism depends on the concentration of glucose in the blood and the glomerular filtration rate (GFR). Inhibition of SGLT2 in patients with type 2 diabetes mellitus and hyperglycemia results in excess urinary glucose excretion.

Metformin belongs to the group of biguanides, have hypoglycemic properties and help lower blood glucose levels both on an empty stomach and after meals. It does not stimulate the production of insulin, therefore, does not lead to the development of hypoglycemia.

Indications

Treatment of type 2 diabetes in adults as an adjunct to diet and exercise regimen:

— if the use of the maximum tolerated dose of metformin alone is not enough;

— if the use of metformin in combination with other drugs for the treatment of diabetes does not provide sufficient glycemic control;

Dosage and administration

The recommended dose is 1 tablet twice a day. The dose is adjusted individually based on the patient’s current regimen, efficacy and tolerability of the recommended daily dose of 10 mg or 25 mg empagliflozin, while not exceeding the maximum recommended daily dose of metformin 2000 mg.

Contraindications

Hypersensitivity to the active substances or to any of the excipients;

— any type of metabolic acidosis;

— diabetic coma;

Side effects

The most commonly reported adverse reactions in clinical studies were hypoglycemia (when used with insulin and/or sulfonylurea), urinary tract infections, genital infections, and frequent urination.

Storage

Store at a temperature not exceeding 30°C.

Package:

The carton box contains 1, 2 or 3 blisters of 10 tablets, paper leaflet.