Index of drugs

Non-insulin-dependent diabetes (type 2) in adults when diet, exercise and weight loss are not enough to maintain normal blood glucose.

1 tabl about release contains 30 mg of gliclazide.

Oral hypoglycemic drug from the sulfonylurea group. Gliclazide reduces the amount of Glucose in the blood, stimulating insulin secretion by the β cells of the Langerhans Islands. Increased postprandial insulin secretion and protein C in the pancreas persists even after 2 years of treatment. In type 2 diabetes, gliclazide restores the early growth of insulin secretion in the presence of glucose and increases the second phase of insulin secretion. There is a significant increase in insulin concentration in response to food or glucose induced stimulation. Gliclazide reduces the formation of micro-thrombi in two mechanisms that can be included in diabetic complications by: partially inhibiting platelet aggregation and adhesion, together with reduced activation of platelet markers (β-thromboglobulin, thromboxane B₂); effect on fibrinolytic activity of the vascular endothelium with increased tPA activity. The gliclazide absorption is complete. The presence of food does not affect the rate or extent of absorption. After oral administration, the plasma concentration of the drug increases gradually for the first 6 h, and then does not change between 6 and 12 h after administration. Plasma protein binding is approximately 95%. A single daily dose of the preparation allows the maintenance of a therapeutic plasma gliclazide concentration for over 24 hours. Gliclazide is metabolised mainly in the liver and excreted in the urine: Only 1% of unchanged in the urine is detected. No active metabolites were detected in the plasma. T_0,5 gliclazide elimination is 12-20 h.

Hypersensitivity to gliclazide or to any of the excipients, other sulfonylureas or sulfonamides. Diabetes type 1. Diabetic pre-coma or diabetic coma, ketosis, diabetic acidosis. Severe renal or hepatic failure - in these cases the use of insulin is recommended. Miconazole treatment. Lactation.

Treatment with the product can only be used by patients who regularly take meals (including breakfast). The occurrence of hypoglycaemia is more likely during low-calorie diets, as a result of prolonged or strenuous exercise, alcohol consumption or when combined treatment with other hypoglycaemic agents is used. Factors that increase the risk of hypoglycaemia: the patient refuses or is unable to cooperate (especially elderly patients); malnutrition, irregular meal times, skipping meals, periods of fasting or changing the diet; imbalance between physical effort and the supply of carbohydrates; renal failure; severe liver failure; overdose of the drug; some endocrine disorders - thyroid dysfunction, hypopituitarism and adrenal insufficiency; concurrent administration of some other medicines. In patients with liver failure or severe renal impairment, hypoglycaemia may be prolonged, which may require appropriate measures to be taken. The following factors may affect glycemic control in patients treated with antidiabetic agents: fever, trauma, infection or surgery. In some cases, insulin may need to be given. The effectiveness of the hypoglycaemic effect of each oral antidiabetic drug, including gliclazide, decreases over time in many patients. This may be due to a gradual increase in diabetes or a reduction in response to treatment. This phenomenon, known as secondary ineffectiveness, in contrast to the original one, when the active substance is ineffective as the first-line treatment. Before classifying the patient's secondary ineffectiveness, appropriate dose modification should be considered and the patient's compliance with dietary recommendations should be checked.The use of sulphonylurea in patients with G-6-PD deficiency may lead to the development of anemia - these patients need to be cautious and consider treatment with a class other than sulphonylurea. There are no data and clinical trials on use in children.

The use of oral hypoglycemic agents during pregnancy is inappropriate - insulin is the drug of first choice. It is recommended to discontinue oral hypoglycemic agents and initiate insulin therapy before or immediately after becoming pregnant. Diabetes control should be obtained before pregnancy to reduce the risk of birth defects in the fetus due to decompensated diabetes in the mother. The use of the drug is contraindicated in women who are breastfeeding.

Common: hypoglycaemia. Uncommon: abdominal pain, nausea, vomiting, indigestion, diarrhea, constipation. Rare: changes in the morphological picture of the blood (including anemia, leukopenia, thrombocytopenia, granulomatopenia), transient visual disturbances (may occur especially at the beginning of treatment, as a result of changes in blood glucose), rash, pruritus, urticaria, erythema, maculopapular rashes, bullous reactions. Rare AST, ALT and alkaline phosphatase activity has been observed rarely, and in some cases hepatitis. Treatment should be discontinued if cholestatic jaundice occurs. Other problems with the use of other sulphonylureas include anemia, agranulocytosis, haemolytic anemia, pancytopenia and allergic vasculitis, increased liver enzymes, and even liver dysfunction (eg cholestasis and jaundice) and hepatitis which resolved after discontinuation of a sulphonylurea or , in isolated cases, lead to life-threatening liver failure.

Orally. Adults: daily dose is 30-120 mg, once, at breakfast. The dose should be adjusted depending on the patient's metabolic response (blood Glucose, HbA_1c). The recommended starting dose is 30 mg / day. If the blood glucose concentration is controlled effectively, this dose can be used as maintenance treatment. If the blood glucose is not adequately controlled, the dose may be gradually increased to 60, 90 or 120 mg per day. The dose should not be increased more frequently than at least after 1 month, with the exception of patients whose blood glucose levels have not decreased after 2 weeks of treatment. In such cases, the dose can be increased at the end of the 2nd week of treatment. The maximum recommended daily dose is 120 mg.Replacement of gliclazide treatment with 80 mg tablets (immediate release form) with Gliclastad: 1 tabl. Glycoside 80 mg is comparable to 1 tablet prolonged release 30 mg - the change can be carried out under the condition of thorough monitoring of blood parameters.Replacement of another oral anti-diabetic preparation with Gliclastad. The preparation can be used to replace other oral antidiabetic medicines. during the exchange, the dose and T should be taken into account_0,5 previously used antidiabetic drug. It is not necessary to apply a transitional period. A starting dose of 30 mg should be used and adjusted so that it is adjusted for the patient's blood glucose response as described above. After treatment with hypoglycaemic sulphonylureas with an extended T_0,5 it may be necessary to stop treatment for several days to prevent the occurrence of an additive effect of two drugs and the occurrence of hypoglycaemia. The dosing regimen should be the same in these situations as at the beginning of the treatment, i.e. treatment should start at a dose of 30 mg per day, and then increase it gradually depending on the metabolic response.Combination therapy with other antidiabetic agents: the product can be combined with biguanides, alpha-glucosidase inhibitors or insulin. In patients whose blood glucose is not adequately controlled with the preparation, combination therapy with insulin can be initiated under close medical supervision. No dose adjustment is required in patients with mild or moderate renal impairment (these patients should be carefully monitored) and in elderly patients (over 65 years of age).Patients with risk of hypoglycaemia (malnourished or poorly fed patients, severe or insufficiently compensated endocrine disorders - hypopituitarism, hypothyroidism, adrenal insufficiency, cessation of long-term treatment and / or treatment with high doses of corticosteroids, severe vascular disease - severe coronary heart disease, severe carotid insufficiency, peripheral vascular disease), a minimum initial dose of 30 mg is recommended.
The tablets should be swallowed whole without chewing.