Gliclazide MB modified release tablets 60mg №10×6

Name Gliclazide MB tab. with mod. release 60mg cont cell unitary enterprise No. 10×6 The main active substance Gliclazide Release form Modified release tablets. Dosage 60 mg Pharmacotherapeutic group Oral hypoglycemic agents, excluding insulins. Sulfonamides, sulfonylurea derivatives. Indications for useInsulin-dependent diabetes (type II) in adults in cases where diet, exercise and weight loss are insufficient to maintain normal blood glucose levels. If you have any doubts or questions, please consult your doctor. Method of administration and doses For oral administration. The drug is intended only for the treatment of adults. The risk on tablets with a dosage of 60 mg is not intended for dividing the tablet. The daily dose of the drug Gliclazide MB can vary from 30 mg to 120 mg, which should be taken 1 time per day during breakfast. It is recommended to swallow the tablets whole, without chewing. If you miss a dose of the drug, you can not increase the dose the next day. As with other hypoglycemic drugs, the dose of this drug in each case must be selected individually, depending on the metabolic response of the patient (blood glucose, HbAlc). The initial recommended dose is 30 mg per day. In the case of effective control of blood glucose levels, this dose can be used as maintenance therapy. If adequate glucose control is not obtained, the dose can be gradually increased to 60 mg, 90 mg or 120 mg per day. The interval between successive increases in the dose of the drug should be at least 1 month, unless after two weeks of therapy the blood glucose level does not decrease. In such cases, the dose can be increased as early as two weeks after the start of treatment. The maximum recommended daily dose is 120 mg. One Gliclazide MB 60 mg modified release tablet is equivalent to two Gliclazide MB 30 mg modified release tablets. Switching from another antidiabetic drug to a drug Gliclazide MB Gliclazide MB can be used to replace other oral antidiabetic drugs. When switching, the dosage and half-life of the previous antidiabetic drug should be taken into account. As a rule, no transition period is required. Reception should be started with a dose of 30 mg, with subsequent adjustment depending on the response of blood glucose levels, as described above. When switching from hypoglycemic drugs of the sulfonylurea group with a prolonged half-life, a drug-free period of several days may be necessary to avoid the additive effect of the two drugs, which can lead to hypoglycemia. The transition to the drug Gliclazide MB should be carried out according to the procedure described for the start of treatment, i.e. the initial dosage is 30 mg / day, followed by a gradual increase in dose, depending on the metabolic response. Use in combination with other antidiabetic medicinal products Gliclazide MB may be used in combination with biguanidines, alpha-glucosidase inhibitors or insulin. In patients whose blood glucose levels are not adequately controlled by taking the drug Gliclazide MB, insulin therapy may be prescribed under close medical supervision. Special groups of patients Elderly people Recommended doses for the elderly are identical to those for adults under 65 years of age. Renal insufficiency The recommended doses of the drug for mild to moderate renal insufficiency are identical to those for persons with normal renal function, under close medical supervision. Patients with an increased risk of developing hypoglycemia: with insufficient or malnutrition; with severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotropic hormone deficiency); after the abolition of previous long-term and / or high-dose corticosteroid therapy; in severe vascular diseases (severe coronary heart disease, severe carotid artery obstruction, diffuse vascular disorders). It is recommended to start taking the drug with a minimum daily dose of 30 mg. Children The efficacy and safety of gliclazide in children and adolescents have not been established. No data available. If you have any doubts or questions, please consult your doctor. Use during pregnancy and lactation Pregnancy Data on the use of gliclazide in pregnant women are limited or absent (less than 300 pregnancy outcomes), although there are some data on other drugs of the sulfonylurea group. In animal studies, gliclazide has not been shown to be teratogenic. For precautionary reasons, it is desirable to avoid the use of gliclazide during pregnancy. A patient with diabetes should be monitored prior to planned conception to reduce the risk of congenital abnormalities associated with uncontrolled diabetes. Oral hypoglycemic agents are not used; insulin is the first-line treatment for diabetes during pregnancy. It is recommended to switch from oral hypoglycemic therapy to insulin before conception or immediately after the fact of pregnancy has been confirmed. Breast-feeding There is no data on whether gliclazide and its metabolites are excreted in milk. Given the risk of hypoglycaemia in the newborn, this medicinal product is contraindicated in breast-feeding. A risk to newborns and infants cannot be excluded. Fertility Effects on fertility and reproductive function in male and female rats have not been identified. Influence on the ability to drive vehicles or potentially dangerous mechanisms The effect of gliclazide on the ability to drive vehicles and use machinery is absent or insignificant. However, patients should be able to recognize the symptoms of hypoglycemia and exercise caution when driving or using machines, especially at the start of treatment. Precautions Hypoglycemia This therapy should only be used in patients with a guaranteed regular meal (including breakfast). The importance of regular carbohydrate intake is due to the increased risk of hypoglycemia when eating is delayed, insufficient, or low in carbohydrates. The risk of hypoglycemia increases with a low-calorie diet, after prolonged or excessive exercise, alcohol consumption, or in the case of combined use of several hypoglycemic drugs. Hypoglycemia may develop after taking drugs of the sulfonylurea group. Sometimes it is severe and protracted, requiring the patient to be hospitalized and administered glucose for several days. To reduce the risk of hypoglycemic attacks, careful selection of patients, the correct choice of dose and clear recommendations for taking it are necessary. Factors that increase the risk of developing hypoglycemia: Refusal or (especially in the elderly) inability to follow the instructions of a doctor; Inadequate or improper diet, irregular intake or skipping meals, periods of fasting or changes in diet; Imbalance in exercise and carbohydrate intake; Kidney failure; Severe hepatic insufficiency; Overdose of gliclazide; Some endocrine disorders: thyroid dysfunction, hypopituitarism and adrenal insufficiency; Simultaneous administration of certain other drugs. Insufficiency of liver or kidney function: pharmacokinetic and / or pharmacodynamic parameters of gliclazide may change in patients with hepatic or severe renal insufficiency. In such patients, episodes of hypoglycemia may be longer, which requires the adoption of adequate measures. Informing Patients It is necessary to inform the patient and his family about the risk of developing hypoglycemia, its symptoms and conditions that contribute to its development. It is also necessary to explain what primary and secondary drug resistance is. The patient should be informed about the potential risks and benefits of the proposed treatment, and about other types of therapy. The patient should be explained the importance and consistency of diet, the need for regular exercise and control of blood glucose levels. Inadequate blood glucose control The effectiveness of blood glucose control in a patient receiving antidiabetic therapy may be reduced by the following factors: St. John’s wort (Hypericum perforatum), fever, trauma, infection, or surgery. In some cases, insulin administration may be required. The hypoglycemic efficacy of any oral antidiabetic agent, including gliclazide, decreases over time in many patients: this may be due to the progression of diabetes or a weakening of the response to the drug. This phenomenon is known as secondary failure of therapy, in contrast to its primary failure already at the very beginning of the use of the first-line drug. The conclusion about the secondary lack of effect can be made only after an adequate dose adjustment and subject to the patient’s diet. Abnormal blood glucose levels Abnormal blood glucose levels, including hypoglycemia and hyperglycemia, have been reported in diabetic patients receiving fluoroquinolones, especially in elderly patients. Careful monitoring of blood glucose levels is recommended for all patients receiving both gliclazide and a drug of the fluoroquinolone group. Laboratory Tests When assessing blood glucose control, measurement of glycated hemoglobin (or fasting venous plasma glucose) is recommended. Self-monitoring of blood glucose levels may also be helpful. The administration of sulfonylurea drugs to patients with G6PD deficiency can lead to hemolytic anemia. Since gliclazide belongs to the chemical class of drugs of the sulfonylurea group, care should be taken when prescribing it to patients with G6PD deficiency and consideration should be given to alternative treatment with a drug of a different class. Excipients Gliclazide should not be given to patients with rare hereditary problems of lactose intolerance, the Lapp lactase deficiency or poor glucose-galactose absorption. Interactions with other drugsAlways tell your doctor what medicines you are taking or have recently taken, even if they are over-the-counter medicines. Increased risk of hypoglycemia Contraindicated combinations Miconazole (when administered systemically or applied to the oral mucosa in the form of a gel): enhances the hypoglycemic effect of gliclazide, symptoms of hypoglycemia may develop up to hypoglycemic coma. Not recommended combinations Phenylbutazone (systemic administration) enhances the hypoglycemic effect of sulfonylurea derivatives (replaces their bonds with plasma proteins and / or slows down their excretion from the body). It is preferable to use another anti-inflammatory agent, as well as to warn the patient and explain to him the importance of self-monitoring of blood glucose levels. If necessary, the dose should be adjusted during and after anti-inflammatory drug therapy. Alcohol: increases hypoglycemia by suppressing compensatory reactions, which may contribute to the development of hypoglycemic coma. It is necessary to refrain from drinking alcohol and taking medicines that contain alcohol. Combinations requiring special precautions An increase in the hypoglycemic effect and, therefore, in some cases, hypoglycemia, is possible when taking one of the following drugs: other antidiabetic drugs (insulins, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase IV inhibitors, GLP-1 receptor agonists), β-blockers, fluconazole, angiotensin-converting enzyme inhibitors (captopril, enalapril), H2-receptor antagonists, MAO inhibitors, sulfonamides, clarithromycin and non-steroidal anti-inflammatory drugs. Risk of increased blood glucose level Combinations that are not recommended Danazol has a diabetogenic effect. If it is impossible to refuse the use of danazol, it is necessary to explain to the patient the importance of monitoring the concentration of glucose in the blood and urine. Sometimes it is necessary to adjust the dose of the antidiabetic agent during and after danazol therapy. Combinations requiring caution Chlorpromazine (neuroleptic): in high doses (more than 100 mg of chlorpromazine per day) increases blood glucose levels, reducing insulin secretion. It is necessary to inform the patient about this and explain the importance of self-monitoring of glucose levels. It may be necessary to adjust the dose of the antidiabetic drug during and after antipsychotic therapy. Glucocorticosteroids (systemic and local use: intra-articular, dermal and rectal administration) and tetracosactrin increase blood glucose levels with the possible development of ketoacidosis (reduced carbohydrate tolerance under the influence of glucocorticosteroids). It is necessary to inform the patient about this and explain the importance of self-monitoring of glucose levels. It may be necessary to adjust the dose of the antidiabetic drug during and after glucocorticosteroid therapy. Ritodrine, salbutamol, terbutaline (systemic intravenous use): increased blood glucose levels under the action of ?-2 agonists. Emphasis should be placed on the importance of self-monitoring of blood glucose levels. If necessary, transfer the patient to insulin therapy. Hypericum perforatum preparations: reduce the concentration of gliclazide. The importance of self-monitoring of blood glucose levels should be emphasized. Risk of abnormal blood glucose levels Combinations requiring caution Fluoroquinolones: when used simultaneously with gliclazide, the patient should be warned about the possibility of abnormal blood glucose levels and emphasize the importance of self-monitoring of blood glucose levels. Combinations to be considered Taking anticoagulant drugs (warfarin): taking drugs of the sulfonylurea group may lead to an increase in the anticoagulant effect of such drugs. Dose adjustment of the anticoagulant may be required. Contraindications This medicinal product should not be used in the following cases: Hypersensitivity to gliclazide or any other of the ingredients that make up the medicinal product, other drugs of the sulfonylurea group, sulfonamides; Insulin-dependent diabetes (type I diabetes); Diabetic ketoacidosis, precoma and diabetic coma; Severe renal or hepatic insufficiency: in such cases it is recommended to use insulin; Miconazole therapy (see “Interaction with other drugs”); Breast-feeding period. Composition Each tablet contains: Active substance: gliclazide – 60 mg; Excipients: anhydrous colloidal silicon dioxide, hypromellose, sodium stearyl fumarate, talc, lactose monohydrate. Overdose Overdose of drugs of the sulfonylurea group can cause hypoglycemia. Symptoms of moderate hypoglycemia, without loss of consciousness or signs of neurological disorders, should be corrected by carbohydrate intake, dose adjustment and / or dietary changes. The doctor should closely monitor the patient’s condition until he is satisfied that the patient is not in danger. Severe hypoglycemic episodes accompanied by coma, convulsions or other neurological disorders are possible, they should be considered as cases requiring emergency care, with immediate hospitalization of the patient. If a hypoglycemic coma occurs or is suspected, the patient should rapidly inject 50 ml of concentrated glucose solution (20-30% intravenously) and then continue infusion with a more dilute glucose solution (10%) at a rate that will maintain blood glucose concentration at the level more than 1 g/l. The patient’s condition should be closely monitored, and, depending on his condition after the attack, the doctor decides whether to continue monitoring or cancel it. Dialysis does not alleviate the patient’s condition due to the strong binding of gliclazide to blood proteins. Side effects The most common adverse reaction when using gliclazide is hypoglycemia. As with other drugs of the sulfonylurea group, Gliclazide MB can cause hypoglycemia if meals are not taken regularly and especially if meals are skipped. Possible symptoms of hypoglycemia include: headache, acute hunger, nausea, vomiting, fatigue, sleep disturbances, agitation, aggressiveness, poor concentration, decreased ability to assess the situation and slow reactions, depression, clouding of consciousness, visual and speech disorders, aphasia , tremor, paresis, decreased sensitivity, dizziness, feeling of helplessness, loss of self-control, delirium, convulsions, shallow breathing, bradycardia, drowsiness and loss of consciousness, which can result in coma and death. In addition, signs of adrenergic dysregulation such as sweating, clammy skin, anxiety, tachycardia, high blood pressure, palpitations, angina, and cardiac arrhythmias may develop. Usually these clinical manifestations disappear after the intake of carbohydrates (sugar). At the same time, artificial sweeteners are ineffective. Experience with other drugs of the sulfonylurea group indicates the possibility of recurrence of hypoglycemia, even in cases where the measures taken to eliminate it initially seemed effective. In severe and prolonged attacks of hypoglycemia, even if it can be temporarily eliminated by taking sugar, urgent medical attention or even hospitalization is necessary. Other undesirable effects Gastrointestinal disorders: nausea, diarrhea, dyspepsia, constipation, abdominal pain, vomiting. These symptoms are less common when Gliclazide MB is administered with breakfast. The following side effects have rarely been reported: Skin and subcutaneous tissue disorders: rash, pruritus, urticaria, angioedema, erythema, maculopapular rashes, bullous reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) and, in exceptional cases, drug rash with eosinophilia and systemic manifestations (DBESS syndrome). Blood and lymphatic system disorders: hematological changes. It can be anemia, leukopenia, thrombocytopenia, granulocytopenia. These symptoms usually disappear after the drug is stopped. Liver and biliary tract disorders: increased levels of “liver” enzymes (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase), hepatitis (separate cases). If cholestatic jaundice occurs, treatment should be discontinued. These symptoms usually disappear after the drug is stopped. On the part of the organ of vision: transient visual disturbances, especially at the beginning of treatment, due to changes in blood glucose levels. Effects associated with this pharmacological group As with other drugs of the sulfonylurea group, the following undesirable effects were observed: cases of erythrocytopenia, agranulocytosis, hemolytic anemia, pancytopenia, allergic vasculitis, hyponatremia, elevated liver enzymes, and even abnormal liver function (for example, cholestasis and jaundice) and hepatitis, which resolved after discontinuation of the sulfonylurea, although in some cases led to life-threatening liver failure. In the event of adverse reactions, including those not listed in this leaflet, you must stop taking the drug and consult a doctor. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Gliclazide MB modified release tablets 60mg No. 10×6