Fonylin MR 60mg sustained-release tablets

UP TO 18 YEARS
There is no data on the safety and efficacy of use in children.

18 TO 65 YEARS OLD
Oral use only. The daily dose of gliclazide may vary from half to two tablets per day, i.e. from 30 to 120 mg taken orally in a single intake at breakfast time.

As with any hypoglycemic agent, the dose should be adjusted according to the individual patient’s metabolic response (blood glucose, HbA1c).

The recommended starting dose is 30 mg daily (half a tablet of FONYLIN MR 60 mg).

If blood glucose is not adequately controlled, this 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 this case, an increase of the dose may be suggested at the end of the second week of treatment.

The maximum recommended daily dose is 120 mg per day. The breakability of the FONYLIN MR 60 mg tablet enables flexibility of dosing to be achieved.

65 YEARS OLD AND ABOVE
In patients over 65 years of age, FONYLIN MR 60 mg should be prescribed using the same dosing regimen recommended for patients under 65 years of age.

ADMINISTRATION
It is recommended to swallow the tablet(s) without crushing or chewing. If a dose is forgotten, the dose taken the next day must not be increased.

PATIENTS WITH RENAL INSUFFICIENCY
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.

PATIENTS AT RISK OF HYPOGLYCEMIA
It is recommended to start the treatment systematically with the minimum dose of 30 mg per day.

IN COMBINATION WITH OTHER ANTIDIABETICS
FONYLIN MR 60 mg can be given in combination with biguanides, alpha glucosidase inhibitors or insulin. In patients who are not adequately controlled with FONYLIN MR 60 mg, concomitant insulin therapy can be initiated under close medical supervision.

SWITCHING FROM OTHER ANTIDIABETIC AGENTS
FONYLIN MR 60 mg can be used to replace other oral antidiabetic agents.
In that case, the dosage and the half-life of the previous antidiabetic agent should be taken into account.

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 described above.

When switching from a hypoglycemic 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 hypoglycemia. During this switch, the procedure described for initiating treatment with FONYLIN MR 60 mg should be used, i.e. a starting dose of 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic results.

Non-insulin-dependent diabetes (type 2) in Adults when dietary measures, physical exercise, and weight loss alone are not sufficient to control blood glucose.