Glukonorm plus, 2.5mg+500 mg 30 pcs

Oral hypoglycemic agent (second generation sulfonylurea derivative + biguanide)

Indications

Type 2 diabetes mellitus in adults:

– when diet therapy, exercise, and prior monotherapy with metformin or a sulfonylurea derivative are ineffective;

– to replace prior therapy with two drugs (metformin and a sulfonylurea derivative) in patients with stable and well-controlled glycemia levels.

Active ingredient

Composition

Active substances:

Glibenclamide – 2.50 mg,

metformin hydrochloride – 500 mg.

Auxiliary substances:

Microcrystalline cellulose – 61.50 mg,

Hyprolose (hydroxypropyl cellulose) – 12.00 mg,

croscarmellose sodium – 18.00 mg,

magnesium stearate – 6.00 mg.

Shell for dosage of 2.5 mg + 500mg:

. OPADRY® 20A230018 Orange [hypromellose (hydroxypropyl methylcellulose 6 cPs) – 7.92 mg, hyprolose (hydroxypropyl cellulose) – 4.62 mg, talc – 3.78 mg, titanium dioxide – 1.65 mg, sunset yellow dye (E110) – 0.03 mg] – 18.00 mg

How to take, the dosage

The dose of the drug is determined by the doctor individually for each patient depending on the level of glycemia. The initial dose is 1 tablet of Glukonorm® Plus 2.5 mg + 500 mg once a day. To avoid hypoglycemia, the initial dose should not exceed the daily dose of glibenclamide (or the equivalent dose of another previously taken sulfonylurea drug) or metformin, if they were used as first-line therapy. It is recommended that the dose be increased by no more than 5 mg of glibenclamide + 500 mg of metformin per day every 2 or more weeks to achieve adequate blood glucose control.

Replacement of prior combination therapy with metformin and glibenclamide: The starting dose should not exceed the daily dose of glibenclamide (or the equivalent dose of another sulfonylurea drug) and metformin taken previously. Every 2 or more weeks after the start of treatment, the dose of the drug is adjusted according to the level of glycemia.

The maximum daily dose is 6 tablets of Gluconorm® Plus 2.5 mg + 500 mg.

The dosing regimen

The dosing regimen depends on the individual prescription:

For doses of 2.5 mg + 500 mg

– once daily, in the morning at breakfast, when prescribed 1 tablet per day;

– twice daily, in the morning and evening, when prescribed 2 or 4 tablets per day.

For doses of 2.5 mg + 500 mg

Three times daily, morning, afternoon, and evening, when prescribing 3, 5, or 6 pills per day.

The tablets should be taken with meals. Each ingestion of the drug should be accompanied by a meal that is high enough in carbohydrates to prevent hypoglycemia.

Elderly patients

The dose of the drug is adjusted according to the state of renal function. The initial dose should not exceed 1 tablet of Gluconorm® Plus 2.5 mg + 500 mg. Regular evaluation of renal function should be carried out.

Children

The drug Glukonorm® Plus is not recommended for use in children.

Special Instructions

Contraindications

– Hypersensitivity to metformin, glibenclamide or other sulfonylurea derivatives or excipients;

– type 1 diabetes mellitus;

– diabetic ketoacidosis, diabetic precoma, diabetic coma;

– renal insufficiency or impaired renal function (creatinine clearance less than 60 ml/min);

– acute conditions that may lead to changes in renal function: dehydration, severe infection, shock, intravascular administration of iodine-containing contrast agents (see “

– acute or chronic diseases that are accompanied by tissue hypoxia: cardiac or respiratory failure, recent myocardial infarction, shock;

– hepatic failure;

– porphyria;

– pregnancy, period of breastfeeding;

– concomitant use of miconazole;

– major surgical operations;

– chronic alcoholism, acute alcohol intoxication;

– lactoacidosis (including a history of

– adherence to a hypocaloric diet (less than 1000 calories per day).

The drug is not recommended for persons older than 60 years of age who perform heavy physical work due to the increased risk of lactoacidosis in them.

Fever syndrome, adrenal insufficiency, hypothyroidism, thyroid disease with uncompensated thyroid dysfunction.

Side effects

The following side effects may occur during treatment with Gluconorm® Plus.

The side effects are presented according to the effect on organs and organ systems.

The following adverse events noted with Glukonorm® Plus are distributed by frequency of occurrence according to the following gradation: Very common (≥ 1/10), common (≥ 1/100 to 1/10), infrequent (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000).

In each group, adverse effects are presented in decreasing order of severity.

In metabolic and nutritional aspects:

Hypoglycemia (see “Overdose,” “Special Precautions”).

Rarely: episodes of hepatic porphyria and cutaneous porphyria.

Very rare: lactoacidosis (see “Special Precautions”).

A decrease in absorption of vitamin B12, accompanied by a decrease in its concentration in the blood serum with long-term use of metformin. If megaloblastic anemia is detected, the possibility of this etiology must be considered. Disulfiram-like reaction with alcohol use.

Laboratory findings:

Infrequent: moderate to moderate increases in serum urea and creatinine concentrations.

Very rare: hyponatremia.

The blood and lymphatic system:

Rarely: leukopenia, thrombocytopenia.

very rarely: agranulocytosis, hemolytic anemia, bone marrow aplasia and pancytopenia.

These adverse events disappear after discontinuation of the drug.

Nervous system disorders:

Often: taste disorder (metallic taste in the mouth).

Visually: at the beginning of treatment there may be temporary visual impairment due to decreased blood glucose levels.

Gastrointestinal tract:

Very common: nausea, vomiting, diarrhea, abdominal pain and lack of appetite. These symptoms are more common at the beginning of treatment and in most cases go away on their own. To prevent these symptoms, it is recommended that the drug be taken in 2 or 3 doses; increasing the dose slowly also improves tolerability.

Some skin reactions, such as itching, urticaria, maculopapular rash.

Very rare: cutaneous or visceral allergic vasculitis, erythema polymorphicum, exfoliative dermatitis, photosensitization.

The immune system:

Very rare: anaphylactic shock.

Cross-sensitivity reactions to sulfonamides and their derivatives may occur.

Hepatic and biliary tract disorders:

Very rare: impaired liver function or hepatitis requiring discontinuation of treatment.

Overdose

Pregnancy use

Similarities