Index of drugs

Non-insulin-dependent diabetes (type 2) in adults when dietary compliance, exercise and weight loss are not sufficient to maintain normal blood Glucose levels.

1 tabl Modified release contains 30 mg gliclazide. The preparation contains lactose.

Oral hypoglycemic drug from the sulfonylurea group. Gliclazide reduces blood glucose levels by stimulating insulin secretion by the beta cells of Langerhans. Increased postprandial secretion of insulin and protein C persists 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. A significant increase in insulin secretion is observed as a response to stimulation induced by a meal or glucose. The drug also affects the vessels - it has hemovascular properties. Reduces the formation of micro-thrombi in two mechanisms that may underlie complications of diabetes: by partially inhibiting platelet aggregation and adhesion by reducing the activity of platelet markers (beta-thromboglobulin, thromboxane B2); by affecting the fibrinolytic activity of the vascular endothelium by increasing the activity of tissue plasminogen activator (tPA). After oral administration, the drug is completely absorbed. The meal does not affect the rate or extent of absorption. The plasma concentration of the drug gradually increases during the first 6 h, and then remains unchanged between 6 and 12 h after administration. Plasma protein binding is approximately 95%. The drug is metabolized mainly in the liver and excreted in the urine, with less than 1% of the unchanged form in the urine. No active metabolites were detected in plasma. T_0,5 Glycazide elimination is 12-20 h in the elimination phase. A single daily dose of the preparation allows plasma gliclazide to be maintained for 24 hours.

Hypersensitivity to gliclazide, other sulfonylurea derivatives, sulfonamides or any of the excipients. Type 1 diabetes. Pre-coma or diabetic coma, ketosis and diabetic acidosis. Severe renal or hepatic impairment (in these cases, it is recommended to use insulin). Miconazole treatment. Breastfeeding period.

The use of sulfonylureas in patients with G-6-PD deficiency may lead to haemolytic anemia - caution should be used in this group of patients and alternative treatment should be considered. Treatment with the preparation should only be used in patients who regularly eat (breakfast applies). Due to the risk of hypoglycaemia, it is important to regularly consume carbohydrates. Factors that increase the risk of hypoglycaemia: lack of cooperation on the part of the patient (especially in the elderly), malnutrition, irregular meal times, leaving meals, periods of fasting or dietary changes, lack of balance between exercise and carbohydrate supply, renal failure, severe heart failure liver, overdose of the preparation, some endocrine disorders: thyroid dysfunction, hypopituitarism and adrenal insufficiency; simultaneous use of some medicines. In patients with liver failure or severe renal impairment, hypoglycaemia may be prolonged. The following factors can affect glycemic control in a patient taking antidiabetic medicines: fever, trauma, infection, and surgery. In some cases, it may be necessary to use insulin. The hypoglycaemic effectiveness of the drug decreases with time: this may be due to the gradual increase in diabetes or a reduction in the response to treatment - this is a phenomenon of secondary therapeutic failure; before the patient is diagnosed with secondary therapeutic failure, appropriate dose adjustment and diet modification should be considered. There are no data and clinical trials on use in children. The preparation contains lactose - should not be used in patients with such rare congenital diseases as: galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Oral hypoglycemic medications are not suitable for the treatment of pregnancy - the first-line drug for the treatment of diabetes in pregnant women is insulin. It is recommended to discontinue oral hypoglycemic agents and initiate insulin therapy before attempting to become pregnant, or immediately after finding it. The use of the drug in women who are breastfeeding is contraindicated.

Hypoglycaemia may occur (possible symptoms: headache, severe hunger, nausea, vomiting, tiredness, sleep disturbances, agitation, aggression, impaired attention, decreased attention and slowness of depression, depression, confusion, blurred vision and speech, aphasia, tremor, paresis, sensory disorders, dizziness, feelings of powerlessness, loss of self-control, delirium, convulsions, shallow breathing, bradycardia, drowsiness and loss of consciousness, which can lead to coma and death); in addition, adrenergic stimulation symptoms may occur (sweating, skin moisture, anxiety, tachycardia, increased blood pressure, palpitations, chest pain and arrhythmia). Uncommon: gastrointestinal disorders such as: abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation (can be avoided or minimized when taking the drug during breakfast). Less often: rash, itching of the skin, urticaria, erythema, maculopapular changes, bullous changes, changes in the hematological image of the blood (anemia, leukopenia, thrombocytopenia, granulocytopenia), transient visual disturbances (especially at the beginning of treatment), increased liver enzymes (AST) , ALAT, alkaline phosphatase), hepatitis (isolated cases); in case of cholestatic jaundice, the preparation should be discontinued. Side effects of sulfonylurea: cases of erythrocytopenia, agranulocytosis, haemolytic anemia, pancytopenia and allergic vasculitis, and cases of increased liver enzymes and even liver problems (eg cholestasis and jaundice) and hepatitis that have passed after discontinuation of a sulphonylurea or in individual cases, lead to life-threatening liver failure.

Orally. Adults: the usual recommended dose is 1-4 tabl. daily taken once, at breakfast. The dose should be adjusted individually depending on the patient's response (blood Glucose, HbA1C). The recommended starting dose is 30 mg a day. If effective glycemic control is obtained, the dose can be used as maintenance therapy. If the glycemia 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, except in patients whose blood glucose level has not decreased after 2 weeks of treatment. In such cases, the dose may be increased at the end of the 2nd week of treatment. The maximum recommended daily dose is 120 mg. Change from table Glycaside 80 mg (immediate-release form) for the preparation: 1 tablet a preparation containing 80 mg gliclazide is comparable to 1 tablet prolonged release of Diagen; the change can be carried out under the condition of monitoring blood parameters. When replacing another oral antidiabetic medicinal product with diagen, the dose and half-life of the previously used antidiabetic medicinal product should be taken into account. It is not necessary to apply a transitional period. The starting dose of 30 mg should be used and modified so that it is adjusted for the patient's blood glucose response as described above. By switching from a hypoglycaemic sulphonylurea with a prolonged half-life, a few-day treatment interval may be necessary to avoid the additive effect of 2 drugs that can cause hypoglycaemia. The dosing regimen should be the same in those situations as at the beginning of Diagen use, i.e. the initial dose of 30 mg / day is used, and then it should be gradually increased depending on the patient's metabolic response. The product can be used with biguanides, alpha-glucosidase inhibitors or insulin. In patients with under-controlled blood glucose with Diagen, combination therapy with insulin under close medical supervision should be instituted.In older patients (over 65 years) and in patients with mild to moderate renal impairment, there is no need to change the dosing regimen. 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, vascular disease (severe coronary artery disease) , severe carotid insufficiency, peripheral vascular disease), a minimum initial dose of 30 mg per day is recommended.
The tablets should be swallowed whole, not chewed or crushed.