Dianorm M Tablets (Gliclazide + Metformin)

• Composition :
  Each tablet contains Gliclazide 80 mg + Metformin 500 mg.
• Indications :
  For the treatment of non-insulin dependent diabetes (Type-II) in adult patients where single drug therapy, diet and exercise do not result in adequate glycemic control.
• Pharmacodynamics :
  Gliclazide stimulates the release of insulin from pancreatic β-cells, probably by facilitating Ca2+ transport across the β-cell membranes. It decreases the amount of glucose absorbed from the food and the amount of glucose made by liver. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
• Dosage and administration :
  One tablet twice a day.
• Contraindications :
  Hypersensitivity to the active substance(s) or to any of the excipients. Type I diabetes,Diabetic pre-coma and coma,Diabetes complicated by ketosis or acidosis,Severe renal or hepatic insufficiency. Treatment with miconazole, pregnancy and lactation,Gliclazide should, where possible, be avoided in porphyria.
• Precautions and warnings :
  Hypoglycaemia may occur following administration of sulphonylureas. Metformin may lower vitamin B12 levels. Metformin-associated lactic acidosis has resulted in hypothermia, hypotension, and resistant bradyarrhythmias.
• Use in pregnancy, lactation & pediatrics :
  Gliclazide and Metformin combination is not recommended for use in pregnancy, lactation. Safety and effectiveness of Gliclazide and Metformin combination in paediatric patients have not been established.
• Drug interactions :
  Metformin - Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Hypoglycaemia may be potentiated when a gliclazide is used concurrently with agents such as: long-acting sulfonamides, tuberculostatics, clarithromycin, salicylates, non-steroidal anti-inflammatory agents, probenecid, beta-blockers. Certain drugs such as diuretics (thiazides, furosemide), corticosteroids oral contraceptives (estrogen plus progestogen) and nicotinic acid may induce hyperglycemia and may lead to loss of control of blood sugar. Gliclazide may potentiate the anticoagulant effect of warfarin and other anticoagulants, dosage adjustments may be necessary.
• Adverse reactions :
  The most commonly reported adverse events nausea, vomiting, diarrhoea, abdominal pain and loss of appetite and hypoglycaemia.
• Therapy Area :
  Anti-Diabetic agents