Source: Υπουργείο Υγείας (CY) Revision Year: 2017 Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus
Non-Insulin dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.
The total daily dose may vary from 40 to 320 mg taken orally. The dose should be adjusted according to the individual patient’s response, commencing with 40-80 mg daily (½ – 1 tablet) and increasing until adequate control is achieved. A single dose should not exceed 160 mg (2 tablets). When higher doses are required, Glizorem tablet should be taken twice daily and according to the main meals of the day.
In obese patients or those not showing adequate response to Glizorem tablet alone, additional therapy may be required.
Glizorem can be used to replace other oral antidiabetic agents.
The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to Glizorem.
A transitional period is not generally necessary. A starting dose of 40-80 mg (½ to 1 tablet) should be used and this should be adjusted to suit the patient’s blood glucose response, as described above.
When switching from a hypoglycaemic sulfonylurea with a prolonged half-life, a treatment free period of a few days may be necessary to avoid an additive effect of the two products, which might cause hypoglycaemia.
Glizorem can be given in combination with biguanides, alpha glucosidase inhibitors or insulin.
In patients not adequately controlled with Glizorem, concomitant insulin therapy can be initiated under close medical supervision.
Glizorem should be prescribed using the same dosing regimen recommended for patients under 65 years of age.
In patients with mild to moderate renal insufficiency, the same dosing regimen can be used as in patients with normal renal function with careful patient monitoring. These data have been confirmed in clinical trials.
It is recommended that the minimum daily starting dose of 40-80 mg is used.
The safety and efficacy of Glizorem in children and adolescents have not been established. No data are available.
An overdose of sulphonylureas may cause hypoglycaemia.
Moderate symptoms of hypoglycaemia, without any loss of consciousness or neurological signs, must be corrected by carbohydrate intake, dose adjustment and/or change of diet. Strict monitoring should be continued until the doctor is sure that the patient is out of danger.
Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible and must be treated as a medical emergency, requiring immediate hospitalization.
If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid I.V. injection of 50 mL of concentrated glucose solution (20 to 30%). This should be followed by continuous infusion of a more dilute glucose solution (10%) at a rate that will maintain blood glucose levels above 1 g/L. Patients should be monitored closely and, depending on the patient’s condition after this time, the doctor will decide if further monitoring is necessary.
Dialysis is of no benefit to patients due to the strong binding of gliclazide to proteins.
5 years.
Store below 25°C, protected from light and moisture.
PVC/Aluminium blisters. Pack-sizes of 20, 30 and 100 tablets.
Not all pack-sizes may be marketed.
No special requirements.
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