Gluconorm plus pills 5mg + 500mg, 30pcs

Composition

Active ingredients:

glibenclamide – 5.00 mg,

metformin hydrochloride-500 mg.

Auxiliary substances:

microcrystalline cellulose – 57.20 mg,

hyprolose (hydroxypropylcellulose) – 13.80 mg,

croscarmellose sodium-18.00 mg,

magnesium stearate-6.00 mg.

Shell for dosage of 5 mg + 500 mg:

VIVACOAT ® RM-2 R-050 [hypromellose (hydroxypropylmethylcellulose 6 sPz) – 9.00 mg, hyprolose (hydroxypropylcellulose) – 0,90 mg, polyethylene glycol 3350 was 0.90 mg Gitana dioxide to 4.75 mg, talc – 1,80 mg, dye iron oxide yellow (E 172) and 0.26 mg, dye quinoline yellow (E 104) – 0,37 mg, dye sunset yellow (E 110) – 0.02 mg] – 18,00 mg.

Pharmacological action

Hypoglycemic agent for oral use (second generation sulfonylurea derivative + biguanide)

Indications

Type 2 diabetes mellitus in adults:

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

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

Use during pregnancy and lactation

The use of the drug is contraindicated during pregnancy. The patient should be warned that during treatment with Gluconorm® 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 while taking Gluconorm ® Plus, the drug should be discontinued and insulin treatment should be prescribed. Gluconorm Plus is contraindicated during breast-feeding, as there are no data on its ability to pass into breast milk.

Contraindications

– Hypersensitivity to Metformin, glyburide, or other derivatives of sulfonylurea, as well as auxiliary substances;

– diabetes mellitus type 1;

diabetic ketoacidosis, diabetic precoma, diabetic coma;

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

acute conditions, which can lead to a change in kidney function, dehydration, severe infection, shock, intravascular use of iodinated contrast media (see “Special instructions”);

acute or chronic disease, which are accompanied by hypoxia of tissues: cardiac or respiratory failure, recent myocardial infarction, shock;

– liver failure;

– porphyria;

pregnancy, lactation;

– simultaneous use of miconazole;

– extensive surgery;

chronic alcoholism, acute alcohol intoxication;

– lactic acidosis (including history);

– adherence to a reduced-calorie diet (less than 1000 cal/day).

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

With caution:

Febrile syndrome, adrenal insufficiency, hypofunction of the anterior pituitary gland, thyroid diseases with uncompensated dysfunction of its function.

Side effects

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 observed with the use of Gluconorm Plus are distributed according to the frequency of occurrence in accordance with 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 (

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

From the side of metabolism and nutrition:

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

Rare: attacks of hepatic porphyria and cutaneous porphyria.

Very rare: lactic acidosis (see “Special instructions”).

Reduced absorption of vitamin B12, accompanied by a decrease in its concentration in the blood serum with prolonged use of metformin. If megaloblastic anemia is detected, it is necessary to consider the possibility of such an etiology. Disulfiram-like reaction when drinking alcohol.

Laboratory parameters:

Infrequently: increased serum urea and creatinine concentrations are moderate to moderate.

Very rare: hyponatremia.

Blood and lymphatic system disorders:

Rare: leukopenia, thrombocytopenia.

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

These adverse events disappear after discontinuation of the drug.

Nervous system disorders:

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

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

From the 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 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 tolerability.

From the side of the track and subcutaneous tissues:

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

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

From the immune system:

Very rare: anaphylactic shock.

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

Liver and biliary tract disorders:

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

Interaction

Contraindicated combinations

Related to the use of glibenclamide

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

Metformin-related

iodine-containing contrast agents: depending on renal function, the drug should be discontinued 48 hours before or after intravenous use of iodine-containing contrast agents.

Not recommended combinations

Related to the use of sulfonylurea derivatives

Alcohol:  very rarely, a disulfiram-like reaction (alcohol intolerance) is observed when alcohol and glibenclamide are taken simultaneously. Alcohol intake may increase the hypoglycemic effect (by inhibiting compensatory responses or delaying its metabolic inactivation), which may contribute to the development of hypoglycemic coma. Alcohol and drugs containing alcohol should be avoided during treatment with Gluconorm Plus. Phenylbutazone increases the hypoglycemic effect of sulfonylurea derivatives (replacing sulfonylurea derivatives at the sites of their binding to protein and / or reducing their elimination). It is preferable to use other anti-inflammatory drugs that show less effects, or warn the patient about the need for self-monitoring of the level of glycemia; if necessary, the dose should be adjusted with the combined use of the anti-inflammatory agent and after its discontinuation.

Related to the use of glibenclamide

Bosentan in combination with glibenclamide increases the risk of hepatotoxic effects. It is recommended to avoid taking these medications at the same time. The hypoglycemic effect of glibenclamide may also decrease.

Related to the use of metformin

Alcohol:  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 drugs containing ethanol should be avoided during treatment with Gluconorm Plus.

Combinations that require caution

Related to the use of all hypoglycemic agents

Chlorpromazine:  in high doses (100 mg/day) causes an increase in the level of glycemia (reducing the release of insulin).

Precautions: the patient should be warned about the need for self-monitoring of blood glucose; if necessary, the dose of the hypoglycemic agent should be adjusted during the simultaneous use of the antipsychotic and after discontinuation of its use.

Glucocorticosteroids (corticosteroids) and tetracosactide:  an increase in blood glucose, sometimes accompanied by ketosis (corticosteroids cause a decrease in glucose tolerance).

Precautions: the patient should be warned about the need for self-monitoring of blood glucose; if necessary, the dose of the hypoglycemic agent should be adjusted during the simultaneous use of corticosteroids and after discontinuation of their use.

Danazol it has a hyperglycemic effect. If treatment with danazol is necessary and the latter is discontinued, a dose adjustment of Gluconorm Plus is required under the control of the glycemic level.

beta-2-adrenomimetics:  due to the stimulation of β2-adrenergic receptors, the concentration of glucose in the blood is increased.

Precautions: it is necessary to warn the patient and establish control of blood glucose, it is possible to transfer to insulin therapy.

Diuretics:  increased blood glucose.

Precautions: the patient should be warned about the need for self-monitoring of blood glucose; it may be necessary to adjust the dose of the hypoglycemic agent during simultaneous use with diuretics and after discontinuation of their use.

Angiotensin converting enzyme (ACE) inhibitors (captopril, enalapril) : the use of ACE inhibitors helps to reduce blood glucose. If necessary, the dose of Gluconorm Plus should be adjusted during concomitant use with ACE inhibitors and after discontinuation of their use.

Related to the use of metformin

Diuretics: lactic acidosis that occurs when taking metformin on the background of functional renal failure caused by taking diuretics, especially “loop”.

Glibenclamide-associated

beta-blockers, clonidine, reserpine, guanethidine, and sympathomimetics mask some of the symptoms of hypoglycemia: palpitation and tachycardia; most non-selective beta-blockers increase the frequency and severity of hypoglycemia.

The patient should be warned about the need for self-monitoring of blood glucose, especially at the beginning of treatment.

Fluconazole: an increase in the half-life of glibenclamide with possible manifestations of hypoglycemia. The patient should be warned about the need for self-monitoring of blood glucose; it may be necessary to adjust the dose of hypoglycemic drugs during concomitant treatment with fluconazole and after discontinuation of its use.

Bile acid sequestrants: Concomitant use with Gluconorm Plus reduces the concentration of glibenclamide in blood plasma, which may lead to a decrease in the hypoglycemic effect. You should take Gluconorm Plus at least 4 hours before taking bile acid sequestrants.

Other interactions: combinations to consider

Related to the use of glibenclamide

Desmopressin: glibenclamide may reduce the antidiuretic effect of desmopressin.

Antibacterial drugs from the group of sulfonamides, fluoroquinolones, anticoagulants (coumarin derivatives), monoamine oxidase inhibitors (MAO), chloramphenicol, pentoxifylline, hypolipidermic drugs from the group of fibrates, disopyramide – the risk of hypoglycemia during the use of glibenclamide.

How to take, course of use and 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 Gluconorm 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) 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 blood glucose control.

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

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

Dosage regimen

The dosage regimen depends on the individual appointment:

For dosages of 2.5 mg + 500 mg

– once a day, in the morning during breakfast, with the appointment of 1 tablet per day;

– twice a day, in the morning and in the evening, with the appointment of 2 or 4 tablets per day.

For a dosage of 2.5 mg + 500 mg

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

Tablets should be taken with a meal. Each dose of the drug should be accompanied by a meal with a sufficiently high 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 Gluconorm Plus 2.5 mg + 500 mg. Regular assessment of renal function should be performed.

Children

Gluconorm Plus is not recommended for use in children.

Overdose

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

Mild to moderate symptoms of hypoglycemia without loss of consciousness and neurological manifestations can be corrected by immediate sugar intake. It is necessary to adjust the dose and / or change the diet. The occurrence of severe hypoglycemic reactions in patients with diabetes mellitus, accompanied by coma, paroxysm or other neurological disorders, requires urgent medical care. Intravenous use of dextrose solution is necessary immediately after diagnosis or suspicion of hypoglycemia before the patient is hospitalized. After regaining consciousness, it is necessary to give the patient food rich in easily digestible carbohydrates (in order to avoid the re-development of hypoglycemia).

Prolonged overdose or the presence of associated risk factors can trigger the development of lactic acidosis, since the drug contains metformin (see “Special Instructions”).

Lactic acidosis is a condition that requires urgent medical attention; treatment of lactic acidosis should be carried out in a clinic. Hemodialysis is the most effective treatment method for removing lactate and metformin.

Plasma clearance of glibenclamide may increase in patients with liver disease. Since glibenclamide actively binds to blood proteins, the drug is not eliminated during dialysis.

Special instructions

During treatment with Gluconorm® Plus, it is necessary to regularly monitor the level of glycemia on an empty stomach and after meals. Lactic acidosis Lactic acidosis is an extremely rare but serious complication (high mortality in the absence of urgent treatment) that can occur due to the accumulation of metformin. Cases of lactic acidosis in patients treated with metformin occurred mainly in diabetic patients with severe renal insufficiency. Other associated risk factors should also be considered, such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol consumption, liver failure, and any condition associated with severe hypoxia. The risk of developing lactic acidosis should be considered if there are non-specific signs, such as muscle cramps accompanied by dyspeptic disorders, abdominal pain and severe malaise. In severe cases, acidotic dyspnea, hypoxia, hypothermia, and coma may occur. Diagnostic laboratory parameters are: low blood pH, plasma lactate concentration above 5 mmol / L, increased anion interval, and the lactate/pyruvate ratio. Hypoglycemia: Since Gluconorm Plus contains glibenclamide, taking the drug is associated with the risk of hypoglycemia in the patient. Gradual titration of the dose after starting treatment can prevent the occurrence of hypoglycemia. This treatment can only be prescribed to a patient who adheres to a regular food intake (including breakfast). It is important that carbohydrate intake is regular, as the risk of hypoglycemia increases with late meals, insufficient or unbalanced carbohydrate intake. Hypoglycaemia is most likely to develop with a low-calorie diet, after intense or prolonged physical activity, with alcohol consumption, or when taking a combination of hypoglycaemic agents. Due to compensatory reactions caused by hypoglycemia, sweating, fear, tachycardia, hypertension, palpitations, angina and arrhythmia may occur. The latter symptoms may be absent if hypoglycemia develops slowly, in the case of autonomic neuropathy, or with simultaneous use of beta-blockers, clonidine, reserpine, guanethidine, or sympathomimetics. Other symptoms of hypoglycemia in diabetic patients may include headache, hunger, nausea, vomiting, severe fatigue, sleep disorders, agitation, aggression, impaired concentration and psychomotor reactions, depression, confusion, speech disorders, visual disturbances, trembling, paralysis and paresthesia, dizziness, delirium, convulsions, somnolence, unconsciousness, shallow breathing and bradycardia. Careful use of the drug, dose selection and proper instructions for the patient are important to reduce the risk of hypoglycemia. If a patient has recurrent episodes of hypoglycemia that are either severe or associated with ignorance of symptoms, treatment with other hypoglycemic agents should be considered. Factors contributing to the development of hypoglycemia:- simultaneous use of alcohol, especially during fasting;- refusal or inability of the patient to interact with the doctor and follow the recommendations set out in the instructions for use (especially for elderly patients);- poor nutrition, irregular meals, starvation, or changes in diet;- an imbalance between exercise and carbohydrate intake;- kidney failure;- severe hepatic insufficiency; – overdose of Gluconorm Plus;- some endocrine disorders: insufficiency of the thyroid gland, pituitary gland and adrenal glands;- simultaneous use of individual medications.Renal and hepatic insufficiency The pharmacokinetics and / or pharmacodynamics may vary in patients with hepatic insufficiency or severe renal insufficiency. The hypoglycemia that occurs in such patients may be prolonged, in which case appropriate treatment should be initiated. Blood glucose instability In the event of surgery or other cause of diabetes decompensation, it is recommended to provide for a temporary transition to insulin therapy. Symptoms of hypoglycemia include frequent urination, extreme thirst, and dry skin. Gluconorm Plus should be discontinued 48 hours before elective surgery or intravenous use of an iodine-containing radiopaque agent. Treatment is recommended to resume after 48 hours, and only after kidney function has been evaluated and found to be normal. Renal function Since metformin is excreted by the kidneys, before starting treatment, and regularly thereafter, it is necessary to determine the creatinine clearance and / or serum creatinine content: at least once a year in patients with normal renal function, and 2-4 times a year in elderly patients, as well as in patients with creatinine clearance at the upper limit of normal. Special caution is recommended in cases where renal function may be impaired, such as in elderly patients, or when starting antihypertensive therapy, diuretics, or nonsteroidal anti-inflammatory drugs (NSAIDs). Other safety measures The patient should inform the doctor about the appearance of a bronchopulmonary infection or an infectious disease of the genitourinary organs.

Form of production

Tablets, film-coated from light yellow to yellow in color, oval, biconvex. The cut is white or almost white in color.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Glibenclamide, Metformin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets