NIDEM

What it is

NIDEM is a modified release tablet containing gliclazide , available in 30 mg and 60 mg strengths . Each tablet contains lactose monohydrate as an excipient with known effect .

Approved indications

— Type II diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose .

Dosing overview

The daily dose may vary from 30 mg to 120 mg, with an initial recommended dose of 30 mg, even in elderly patients aged 65 years or older, and a maximum daily dose of 120 mg . A single daily dose provides effective blood glucose control . Titration should be carried out in steps of 30 mg according to fasting blood glucose response, with each step lasting for at least two weeks . NIDEM should be taken with food, with the medication recommended to be taken at breakfast time . Tablets should not be chewed or crushed to maintain the modified release properties .

Key safety warnings

Hypoglycaemia may occur following administration of sulphonylureas, with rarely cases being severe and prolonged and potentially involving hospitalisation with glucose infusion needed for several days . Factors that may increase the risk of hypoglycaemia include patient non-adherence to treatment, malnutrition, irregular mealtimes, skipping meals, fasting or dietary changes, imbalance between physical exercise and carbohydrate intake, renal impairment, severe hepatic impairment, overdose of anti-diabetic agents, and certain endocrine disorders . Gliclazide should only be prescribed if the patient is likely to have a regular food intake including breakfast, and it is important to have a regular carbohydrate intake due to the increased risk of hypoglycaemia if a meal is delayed, an inadequate amount of food is consumed or the food is low in carbohydrate . Treatment of patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency with sulphonylurea agents can lead to haemolytic anaemia, and caution should be used in patients with G6PD deficiency . Patients with rare hereditary problems of galactose intolerance, glucose galactose malabsorption, or Lapp lactase deficiency should not take this medicinal product due to the presence of lactose . The most frequent adverse reaction with gliclazide is hypoglycaemia; hypoglycaemic reactions have been reported following gliclazide administration, although studies have shown that hypoglycaemia is less common with gliclazide than with glibenclamide .

Contraindications

NIDEM is contraindicated in patients with hypersensitivity to gliclazide, other sulphonylureas, sulfonamides, or to any of the excipients . It is contraindicated in Type I diabetes, diabetic ketoacidosis, diabetic pre-coma and coma . NIDEM is contraindicated in severe renal or hepatic impairment, in which cases insulin is recommended . It is contraindicated during treatment with miconazole and during pregnancy and lactation .

Regulatory history

NIDEM gliclazide 80 mg was first listed on the ARTG on 17 August 2001 . The product information was first approved on 27 March 2020 .