Hlybenklamyd, Metformin | Gluconorm plus tablets coated.pl.ob. 2.5 mg + 500 mg 30 pcs.

Latin name

Gluconorm Plus

Release form

Film-coated tablets, pinkish-orange, oval, biconvex. On a slice of white or almost white.



packaging 30 pcs

Pharmacological action of

Hypoglycemic agent for oral administration (2nd generation sulfonylurea derivative + biguanide)

Indications

Type 2 diabetes mellitus in adults:

- with the ineffectiveness of diet therapy, physical exercise and previous monotherapy with metformin or a sulfonylurea derivative

- to replace the previous therapy with two drugs (metformin and a sulfonylurea derivative) we control well with stable.

Contraindications

- Hypersensitivity to metformin, glibenclamide or other sulfonylurea derivatives, as well as

excipients - 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 a change in renal function: dehydration, severe infection, shock, intravascular administration of iodine-containing contrast agents (see Special instructions)

- acute or chronic diseases accompanied by tissue hypoxia: heart or respiratory failure, recent myocardial infarction, shock

- liver failure

- porphyria

- pregnancy , breastfeeding

- concomitant use of miconazole

- extensive surgery

- chronic alcoholism, acute alcohol intoxication

- lactic acidosis (including a history)

- adhering to a low-calorie diet (less than 1000 calories / day).

It is not recommended to use the drug for people over 60 years old who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis in them.

Precautions:

Fever, adrenal insufficiency, hypofunction of the anterior pituitary, thyroid disease with uncompensated dysfunction.

Use during pregnancy and lactation

The use of the drug is contraindicated during pregnancy. The patient should be warned that that during the period of treatment with GluconormВ® Plus, it is necessary to inform the doctor about the planned pregnancy and the onset of pregnancy. When planning pregnancy, as well as in the case of pregnancy during the period of taking the drug GluconormВ® Plus, the drug should be canceled and insulin treatment prescribed.

The drug GluconormВ® Plus is contraindicated in breastfeeding, as there is no evidence of its ability to pass into breast milk.

Composition

Active ingredients: glibenclamide - 2.50 mg, metformin hydrochloride - 500 mg.

Excipients: microcrystalline cellulose - 61.50 mg or 57.20 mg, hyprolose (hydroxypropyl cellulose) - 12.00 mg or 13.80 mg, croscarmellose sodium - 18.00 mg, magnesium stearate - 6.00 mg.

Sheath for a dosage of 2.5 mg + 500 mg: 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 sunset dye yellow (Е110) - 0.03 mg] - 18.00 mg

Dosage and administration

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 the drug Gluconorm® Plus 2.5 mg + 500 mg 1 time per day. To avoid hypoglycemia, the initial dose should not exceed the daily dose of glibenclamide (or the equivalent dose of another previously taken sulfonylurea) or metformin, if they were used as first-line therapy. It is recommended to increase the dose by no more than 5 mg of glibenclamide + 500 mg of metformin per day every 2 or more weeks to achieve adequate control of blood glucose.

Substitution of previous combination therapy with metformin and glibenclamide: the initial dose should not exceed the daily dose of glibenclamide (or the equivalent dose of another sulfonylurea) and metformin taken previously. Every 2 or more weeks after the start of treatment, the dose is adjusted depending on the level of glycemia.

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

Dosing regimen

The dosage regimen depends on the individual purpose:

For dosages of 2.5 mg + 500 mg

- once a day, in the morning during breakfast, when prescribing 1 tablet per day

- twice a day, morning and evening, when prescribing 2 or 4 tablets per day.

For a dosage of 2.5 mg + 500 mg

- three times a day, in the morning, afternoon and evening, with the appointment of 3, 5 or 6 tablets per day.

Tablets should be taken with meals. Each meal should be accompanied by a meal with a high enough carbohydrate content to prevent the occurrence of hypoglycemia.

Elderly patients

The dose of the drug is selected based on the state of renal function. The initial dose should not exceed 1 tablet of the drug Gluconorm® Plus 2.5 mg + 500 mg. Regular assessment of renal function is necessary.

Children

Gluconorm® Plus is not recommended for use in children.

Side effects of

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

Side effects are presented depending on the effect on organs and organ systems.

The following adverse events noted with the use of the drug Gluconorm® Plus are distributed according to the frequency of occurrence according to the following gradation: very often ( 1/10), often ( 1/100 to 1/10), infrequently ( 1 / 1000 to <1/100), rarely ( 1/10000 to <1/1000), very rarely (<1/10000).

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

From the side of metabolism and nutrition:

Hypoglycemia (see Overdose, Special Instructions).

Rarely: bouts of hepatic porphyria and cutaneous porphyria.

Very rare: lactic acidosis (see Special instructions).

Decreased absorption of vitamin B12, accompanied by a decrease in its concentration in serum with prolonged use of metformin. If megaloblastic anemia is detected, the possibility of such an etiology must be considered. Disulfiram-like reaction with alcohol.

Laboratory data:

Infrequently: moderate to moderate increase in serum urea and creatinine concentrations.

Very rare: hyponatremia.

From the blood and lymphatic system:

Rarely: leukopenia, thrombocytopenia.

Very rare: agranulocytosis, hemolytic anemia, bone marrow aplasia and pancytopenia.

These adverse events disappear after discontinuation of the drug.

From the nervous system:

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

From the side of the organ of vision: at the beginning of treatment, temporary visual impairment may occur due to a decrease in blood glucose.

From the gastrointestinal tract:

Very often: nausea, vomiting, diarrhea, abdominal pain and lack of appetite. These symptoms are more common at the beginning of treatment and in most cases pass on their own. To prevent the development of these symptoms, it is recommended to take the drug in 2 or 3 doses, a slow increase in the dose of the drug also improves its tolerance.

From the side of the rut and subcutaneous tissue:

Rarely: skin reactions such as: itching, urticaria, maculopapular rash.

Very rare: skin or visceral allergic vasculitis, polymorphic erythema, exfoliative dermatitis, photosensitivity.

On the part of the immune system:

Very rare: anaphylactic shock.

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

From the liver and biliary tract:

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

Storage conditions

At a temperature not exceeding 25 РC.

Keep out of the reach and sight of children.

Expiration

2 years. Do not use after the expiry date stated on the packaging.

active substance

Glibenclamide, Metformin