DIABREZIDE, GLICLAZIDE

Tablets for oral use. The desired blood glucose levels and the Gliclazide dosage must be determined individually in relation to the degree of diabetes. ADULTS: the usual initial dose is 40-80 mg/day (half to one tablet) before breakfast.

If necessary, the dosage may be increased by 40-80 mg every 7-14 days, until a satisfactory metabolic control is achieved. The maximum dose is 320 mg/day. The usual maintenance dose is 80-160 mg in two daily administrations (before breakfast and before dinner); higher doses (up to 320 mg/day) may be used, although it has not been demonstrated that the increase of doses over 160 mg/day necessarily leads to an improvement of glycemic control.

ELDERLY: the usual initial dose is 40 mg (half tablet) before breakfast, increasing the dose of 40 mg every 7-14 days if necessary. Caution should be used when prescribing doses over 160 mg/day, particularly if renal function is impaired.

3). Gliclazide is not indicated in the treatment of type 1 diabetes mellitus. Gliclazide tablets must be swallowed without chewing preferably 30 minutes before the meal.

At dosages used in the treatment of maturity onset diabetes mellitus, the most frequently reported side effect is hypoglycaemia, which in most cases is the result of overdose or inadequate diet rather than an adverse effect of the drug and therefore can be corrected by dosage reduction.

The following frequencies are used for the description of the occurrence of adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000, not known).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Blood and lymphatic system disorders Rare (≥1/10,000 to <1/1,000):

Leucopoenia, agranulocytosis, thrombocytopoenia, haemolytic anaemia, aplastic anaemia.

Nervous system disorders Rare (≥1/10,000 to <1/1,000):

Dizzines.

Gastrointestinal disorders Common (≥1/100 to <1/10):

Gastrointestinal upset (such as abdominal pain, nausea or vomiting, dyspepsia, diarrhoea, constipation). It can be avoided or minimised if gliclazide is taken with breakfast.

Skin and subcutaneous tissue disorders Rare (≥1/10,000 to <1/1,000):

Skin reactions (erythema, pruritus).

Metabolism and nutrition disorders Common (≥1/100 to <1/10):

Hypoglycemia * (see additional information below).

Rare (≥1/10,000 to <1/1,000):

Slight disulfiram-like reactions after taking alcohol.

Hepatobiliary disorders Rare (≥1/10,000 to <1/1,000):

Sulphonylureas can occasionally cause disturbances of liver functions, which rarely may lead to hepatitis. As per other sulphonylureas, the following skin and subcutaneous tissue disorders have been reported: rash, pruritus, urticaria, angioedema, erythema, rash maculo-papular, dermatitis bullous (as Stevens-Johnson syndrome and Toxic epidermal necrolysis).

* Hypoglycaemia All sulphonylureas can produce hypoglycaemia. This can be prolonged by gliclazide and may lead to severe hypoglycaemia with life-threatening coma. In cases of very slow progression of nervous lesion (autonomous neuropathy) or sympatholytic concomitant therapy (see “Special warning and precautions for use” and “Interactions”), typical premonitory symptoms of hypoglycaemia may be weaker or absent.

Hypoglycaemia is characterised by decrease in blood sugar to less than approx. 50 to 40 mg/dl. g. speech and visual disorders, paralytic symptoms or sensitivity disorders). In severe hypoglycaemia the patient may loose self-control and consciousness.

In this case the patient’s skin is often cool and she/he tends to have cramps. For treatment of hypoglycaemia see “Overdose”. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard.

Use of sulphonylureas must be limited to the treatment of maturity onset diabetes mellitus, not ketogenic, unable to be controlled by diet, and for which insulin therapy is not appropriate.

Warnings and precautions of use concern:

Hypoglycaemia All sulphonylureas, taken in too high doses in relation to the requirement, are capable of producing hypoglycaemia, even of severe degree, which may lead to neurological damage and may have a fatal outcome. Gliclazide can provoke a moderate or severe hypoglycemia in particularly in the following circumstances: - insufficient glucose or caloric intake - too high posology or accidental overdoses - prolonged physical activity - patients with uncompensated thyroid function disorders.

In order to lower the risk of hypoglycemia it is recomended to start the treatment with a low dose of Gliclazide. Proper patient selection and dosage and instructions are important to avoid hypoglycaemic episodes. Renal or hepatic insufficiency may cause elevated drug levels and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycaemic reactions.

Elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency, are particularly susceptible to the hypoglycaemic action of glucose- lowering drugs. Hypoglycaemia may be difficult to recognise in the elderly and in people who are taking beta-adrenergic blocking drugs.

Hypoglycaemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used. g. 9). So that initial corrective action can be taken immediately, patients should carry a minimum of 1-2 lumps of sugar with them at all times.

To reduce the risk of hypoglycaemia a number of precautions should be taken when Gliclazide is first prescribed, including adjusting the dose according to blood glucose levels during the first few months, and beginning treatment with low doses especially in the elderly and in patients with renal and/or hepatic impairment.

Loss of control of blood glucose When a patient stabilised on any diabetic regimen is exposed to stress such a fever, trauma infection, or surgery, a loss of control may occur. At such times, it may be necessary to discontinue gliclazide and administer insulin.

5) should not be considered without careful monitoring of blood glucose levels to avoid hyperglycaemia. Hepatic disease Definite hepatic disease should contraindicate the use of Gliclazide, since gliclazide is almost completely metabolised in the liver; in moderate hepatic disease a dosage reduction is advisable.

Renal disease Although renal disease does not appear significantly to alter the pharmacokinetics of gliclazide, it may be wise to limit the maximum dose when the serum creatinine starts to rise. Elderly Some elderly patients may be more sensitive to the drug; although the plasma clearance is not altered so that increased plasma levels are unlikely, it is wise to start the therapy at the lowest dosage.

The physician gives the patient guidance on the frequency of blood glucose measurements, as well as on whether, how often and when urine test for glucose must be performed. In addition, it is recommended that the quality of metabolic control be checked by regular determinations of glycated haemoglobin.

Gliclazide contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

g. surgery, and severe trauma or infection, - in patients hypersensitive to gliclazide, sulphonylureas or sulphonamides, or any of the excipients in the tablets, - in children, - in pregnancy and in lactating women.