Posology: The daily dose of gliclazide may vary from 30 to 120 mg taken orally in a single intake at breakfast time.
If a dose is forgotten, there must be no increase in the dose taken next day.
As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbA1c).
Initial dose: The recommended initial dose is 30 mg daily.
If blood glucose is effectively controlled, this dose may be used for maintenance treatment.
If blood glucose is not adequately controlled, the dose may be increased to 60, 90 or 120 mg daily, in successive steps. The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment.
The maximum recommended daily dose is 120 mg.
Switching from gliclazide (80 mg) tablets (immediate release formulation) to Gliclada 60 mg tablets with modified release: Two immediate release tablets of gliclazide (160 mg) are comparable to one gliclazide modified-release tablet 60 mg. Consequently, the switch can be performed with careful blood monitoring.
Switchover from another oral antidiabetic medicinal product to Gliclada 60 mg: Gliclada modified-release tablets can be used to replace another oral antidiabetic medicinal product. The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to Gliclada 60 mg modified release tablets.
A transitional period is not generally necessary. A starting dose of 30 mg should be used and this should be adjusted to suit the patient's blood glucose response, as previously described.
When switching from a hypoglycaemic sulphonylurea 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. The procedure described for initiating treatment should also be used when switching to treatment with Gliclada modified release tablets, i.e. a starting dose of 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic response.
Combination with other antidiabetic medicines: Gliclada modified-release tablets can be given in combination with biguanides, alpha-glucosidase inhibitors or insulin. In patients not adequately controlled with Gliclada 60 mg modified-release tablets, concomitant insulin therapy can be initiated under close medical supervision.
Special populations: Elderly: Gliclazide modified-release tablets should be prescribed using the same dosing regimen recommended for patients under 65 years of age.
Patients with renal impairment: In patients with mild to moderate renal impairment, 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.
Patients at risk of hypoglycaemia: undernourishment or malnourishment, severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic insufficiency), withdrawal of a prolonged and/or high-dose corticoid therapy, severe vascular disease (serious coronary heart disease, severe carotid impairment, diffuse vascular disease).
It is recommended that the minimum daily dose of 30 mg is used.
Paediatric population: The safety and efficacy of gliclazide in children and adolescents have not been established.
No data are available in children.
Method of administration: Gliclada is to be taken as a single dose at breakfast time.
It is recommended that the tablet(s) is swallowed whole. The tablet should not be divided into equal halves in order to obtain a 30 mg dose. The tablet should not be chewed or crushed.