Glibenfage, 5 mg+500 mg 30 pcs

Type 2 diabetes mellitus in adults:

• when diet therapy, exercise, and prior monotherapy with metformin or sulfonylurea derivatives are ineffective;
• to replace prior therapy with two drugs (metformin and sulfonylurea derivative) in patients with stable and adequate glycemic control.

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Indications

Type 2 diabetes mellitus in adults:
if diet therapy, physical exercise and previous monotherapy with metformin or sulfonylurea derivatives are ineffective;
to replace previous therapy with two drugs (metformin and a sulfonylurea derivative) in patients with stable and adequate glycemic control.

Pharmacological effect

Pharmacotherapeutic group:

Special instructions

Treatment with Glibenfage is carried out only under the supervision of a doctor! When taking the drug, you must strictly follow your doctor’s recommendations regarding diet and self-monitoring of blood glucose concentrations. It is necessary to regularly monitor the concentration of glucose in the blood on an empty stomach and after meals.

Active ingredient

Glibenclamide, Metformin

Composition

Active ingredients:

glibenclamide 5 mg + metformin hydrochloride 500 mg;

Excipients:

Core:

hypromellose – 16.0 mg,

croscarmellose sodium – 18.0 mg,

sodium stearyl fumarate – 7.0,

povidone K30 – 15.0 mg,

povidone (kollidon F90) – 19.0 mg;

Film shell composition:

hypromellose E15 – 7.0 mg, macrogol 6000 (polyethylene glycol 6000) – 0.9 mg, titanium dioxide – 2.0 mg, polysorbate 80 (Tween 80) – 0.1 mg.

Pregnancy

During pregnancy, the use of a combination of glibenclamide and metformin is contraindicated. The patient should be warned that during treatment with Glibenfage it is necessary to inform the doctor about the planned pregnancy and the occurrence of pregnancy. When planning a pregnancy, as well as in the event of pregnancy occurring while taking the drug, it should be discontinued and insulin therapy should be prescribed.

The combination of glibenclamide and metformin is contraindicated during breastfeeding, since there is no data on its ability to pass into breast milk. If it is necessary to use the drug during breastfeeding, you should switch to insulin therapy or stop breastfeeding.

Contraindications

Hypersensitivity to metformin, glibenclamide or other sulfonylurea derivatives, as well as to other excipients of the drug; type 1 diabetes mellitus; diabetic ketoacidosis, diabetic precoma, diabetic coma; renal failure or impaired renal function (creatinine clearance less than 60 ml/min); acute conditions that can lead to changes in kidney function: dehydration, severe infection, shock, intravascular administration of iodine-containing contrast agents (see “Special Instructions”); acute or chronic diseases that are accompanied by tissue hypoxia: cardiac or respiratory failure, recent myocardial infarction; liver failure; porphyria; pregnancy, breastfeeding period; simultaneous use of miconazole; major surgical interventions, injuries, extensive burns and other conditions requiring insulin therapy; chronic alcoholism, acute alcohol intoxication; lactic acidosis (including history); following a hypocaloric diet (less than 1000 kcal/day); children under 18 years of age.

Side Effects

During treatment with Glibenfage, the following adverse reactions may occur:
WHO classification of the incidence of adverse reactions: very often – ≥1/10 prescriptions, often – from ≥1/100 to <1/10 prescriptions, infrequently - from ≥1/1000 to <1/100 prescriptions, rarely - from ≥1/10000 to <1/1000 prescriptions, very rarely - <1/10000 prescriptions.
Classification of undesirable side reactions in accordance with damage to organs and organ systems (medical dictionary for regulatory activities Med-DRA).

Interaction

Contraindicated combinations

Overdose

In case of overdose, hypoglycemia may develop due to the presence of a sulfonylurea derivative in the drug (see “Special Instructions”).

Storage conditions

In the manufacturer’s original packaging at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

3 years.

Manufacturer

Farmasintez-Tyumen, Russia