Metglib tablets coated. 2.5 mg + 400 mg 40 pcs. (Hlybenklamyd, Metformin)

Latin name

METGLIB

Release form

Tablets.



packaging 40 pcs

Indications

Type 2 diabetes mellitus in adults:

with ineffective diet therapy and previous monotherapy with metformin or sulfonylurea derivatives

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 to other components of the drug Metglib

- type 1 diabetes mellitus

- diabetic ketoacidosis, diabetes mellitus, coma, diabetes mellitus, less than 60 ml / min)

- acute conditions that can lead to a change in kidney function: dehydration, severe infection, shock, intravascular administration of iodine-containing contrast agents

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

- hepatic insufficiency

- porphyria

pregnancy, pregnancy taking miconazole

- infectious diseases, major surgical interventions, injuries, extensive burns and other conditions requiring insulinote rapies

- chronic alcoholism, acute alcohol intoxication

- lactic acidosis (including a history)

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

- children under 18 years of age.

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

Caution:

- febrile syndrome

- adrenal insufficiency

- hypofunction of the anterior pituitary

- thyroid disease (with uncompensated impairment of its function)

- in elderly people over 70 years of age because of the risk of hypoglycemia.

Use during pregnancy and lactation

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

MetglibВ® is contraindicated in breastfeeding, as there is no evidence of its ability to pass into breast milk. If necessary, use of the drug during breastfeeding should switch to insulin therapy or stop breastfeeding.

Composition of

1 tablet contains:

active ingredients:

metformin hydrochloride 400 mg,

glibenclamide 2.5 mg

excipients:

calcium hydrogen phosphate dihydrate 50 mg,

starch sodium marflumec 3 mg,

povidone 52 mg,

microcrystalline cellulose 35.5 mg

film coat:

Opadry orange 20 mg, including: [hypromellose (hydroxypropyl methylcellulose) 6.75 mg,

hyprolysis (hydroxypropyl cellulose) 6.75 mg talcum 4 mg,

titanium dioxide 2.236 mg, s rdlkp dye iron oxide red 0.044 mg,

dye iron oxide yellow 0.22 mg].

Dosage and Administration

Inside.

The dose and regimen of the drug, as well as the duration of treatment are determined by the attending physician, first of all, in accordance with the state of the patient’s carbohydrate metabolism, depending on the concentration of glucose in the blood plasma. As a rule, the initial dose is 1-2 tablets per day with the main meal, with a gradual selection of a dose until a steady normalization of the concentration of glucose in the blood plasma is achieved. The maximum daily dose of Metglib® is 6 tablets, divided into 3 doses.

Side effects of

The following side effects may occur during treatment with Metglib®. WHO classification of the incidence of side effects:

very often - 1/10 appointments (> 10%)

often - from 1/100 to <1/10 appointments (> 1% and

infrequently from 1/1000 to 0. 1% and

rarely - from 1/10000 to 0. 01% and

is very rare -

Classification of unwanted adverse reactions according to damage to organs and organ systems (medical dictionary for regulatory activities Med-DRA).

- Disorders of the blood and lymphatic system:

These adverse events disappear after discontinuation of the drug.

Rarely: leukopenia and thrombocytopenia.

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

- Immune system disorders:

Very rare: anaphylactic shock.

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

- Metabolism and Nutrition Disorders: Hypoglycemia.

Rarely: bouts of hepatic porphyria and cutaneous porphyria.

Very rare: lactic acidosis.

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 ethanol.

- Disorders of the nervous system:

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

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

- Disorders of 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.

- Disorders of the liver and biliary tract:

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

Disorders of the skin and subcutaneous tissue:

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

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

- Laboratory and instrumental data:

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

Very rare: hyponatremia.

Drug Interaction

Contraindications:

Related to the use of glibenclamide

Miconazole can provoke the development of hypoglycemia (up to the development of coma).

Metformin Related

Iodine Contrast: Depending on kidney function, the drug should be discontinued 48 hours before or after intravenous administration of iodine contrast agents.

Recommended combinations: Associated with the use of sulfonylurea derivatives

Ethanol: very rarely a disulfiram-like reaction (ethanol intolerance) is observed when ethanol and glibenclamide are taken concomitantly. Ethanol may increase hypoglycemic activity (by inhibiting compensatory responses or delaying its metabolic inactivation), which may contribute to the development of hypoglycemic coma. Alcohol and ethanol-containing medicines should be avoided during treatment with Metglib®. Phenylbutazone enhances the hypoglycemic effect of sulfonylureas derivatives (replacing sulfonylureas derivatives at sites of protein binding and / or reducing their excretion). It is preferable to use other anti-inflammatory agents that show less interaction, or to warn the patient of the need to independently control the level of glycemia, if necessary, the dose should be adjusted when combined with the anti-inflammatory agent and after its termination.

Related to the use of glibenclamide

Bosentan in combination with glibenclamide increases the risk of hepatotoxic action.

It is recommended to avoid these drugs at the same time. The hypoglycemic effect of glibenclamide can also be reduced.

Metformin Related

Ethanol: The risk of developing lactic acidosis increases with acute alcohol intoxication, especially in the case of starvation, or poor nutrition, or liver failure. Alcohol and ethanol-containing medicines should be avoided during treatment with Metglib®.

Overdose

Hypoglycemia may occur with an overdose due to the presence of a sulfonylurea in the drug.

Mild and moderate symptoms of hypoglycemia without loss of consciousness and neurological manifestations can be corrected by immediate consumption of sugar. Dose adjustments and / or diet regimens should be performed. The emergence of severe hypoglycemic reactions in patients with diabetes mellitus, accompanied by coma, paroxysm, or other neurological disorders, requires immediate medical attention. It is necessary to administer intravenously dextrose immediately after diagnosis or suspected hypoglycemia, before hospitalization of the patient. After regaining consciousness it is necessary to give the sick food, rich in easily digestible carbohydrates (to avoid the development of hypoglycemia).

The clearance of glibenclamide in blood plasma may increase in patients with liver disease. Because glibenclamide actively binds to blood proteins, the drug is not excreted in dialysis.

Prolonged overdose or the presence of associated risk factors can trigger the development of lactic acidosis, since metformin is included in the drug.

Lactic acidosis is a condition that requires urgent medical treatment to treat lactic acidosis in a hospital. Hemodialysis is the most effective treatment for lactate and metformin.

Storage conditions

Must be stored in a well-ventilated, dry, dark place and out of the reach of children, at a temperature not exceeding 30 ° C.

Shelf suitability

3 Year

Deystvuyuschee substances

Hlybenklamyd, Metformin

Prescription conditions from

pharmacies Prescription

dosage form

dosage form

tablets

Kanonfarma, Russia



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