Sulphonylureas.

Generic

Gliclazide 80 mg

Tablets.

Non insulin dependent diabetes mellitus.

Oral administration.

Adults: 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 (1/2 - 1 tablet) and increasing until adequate control is achieved. A single dose should not exceed 160 mg (2 tablets). When higher doses are required, DIAMICRON^® should be taken twice daily and according to the main meals of the day.

In obese patients or those not showing adequate response to DIAMICRON^® alone, additional therapy may be required.

DIAMICRON^® as with other sulphonylureas, is not indicated for the treatment of juvenile onset diabetes mellitus.

Plasma clearance of gliclazide is not altered in the elderly and steady state plasma levels can therefore be expected to be similar to those in adults under 65 years. Clinical experience in the elderly to date shows that DIAMICRON^® is effective and well tolerated. Care should be exercised, however, when prescribing sulphonylureas in the elderly due to a possible age-related increased risk of hypoglycaemia.

DIAMICRON^® should not be used in:

- Juvenile onset diabetes.

- Diabetes complicated by ketosis and acidosis.

- Pregnancy.

- Diabetics undergoing surgery, after severe trauma or during infections.

- Patients known to have hypersensitivity to other sulphonylureas and related drugs.

- Diabetic pre-coma and coma.

- Severe renal or hepatic insufficiency.

Hypoglycaemia: all sulphonylurea drugs are capable of producing moderate or severe hypoglycaemia, particularly in the following conditions:

- in patients controlled by diet alone,

- in cases of accidental overdose,

- when calorie or glucose intake is deficient,

- in patients with hepatic and/or renal impairment; however, in long-term clinical trials, patients with renal insufficiency have been treated satisfactorily, using DIAMICRON^® at reduced doses.

In order to reduce the risk of hypoglycaemia it is therefore recommended:

- to initiate treatment for non-insulin dependent diabetics by diet alone, if this is possible,

- to take into account the age of the patient: blood sugar levels not strictly controlled by diet alone might be acceptable in the elderly,

- to adjust the dose of DIAMICRON^® according to the blood glucose response and to the 24 hour urinary glucose during the first days of treatment.

Dosage adjustments may be necessary:

- on the occurrence of mild symptoms of hypoglycaemia (sweating, pallor, hunger pangs, tachycardia, sensation of malaise). Such findings should be treated with oral glucose and adjustments made in drug dosage and/or meal patterns,

- on the occurrence of severe hypoglycaemic reactions (coma or neurological impairment, see overdose),

- loss of control of blood glucose (hyperglycaemia). When a patient stabilised on any diabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control may occur. At such times, it may be necessary to increase progressively the dosage of DIAMICRON^® and if this is insufficient, to discontinue the treatment with DIAMICRON^® and to administer insulin. As with other sulphonylureas, hypoglycaemia will occur if the patients' dietary intake is reduced or if they are receiving a larger dose of DIAMICRON^® than required.

Care should be exercised in patients with hepatic and/or renal impairment and a small starting dose should be used with careful patient monitoring.

Care should be taken when giving DIAMICRON^® with drugs which are known to alter the diabetic state or potentiate the drug's action.

The hypoglycaemic effect of DIAMICRON^® may be potentiated by phenylbutazone, salicylates, sulphonamides, coumarin derivatives, MAOIs, beta adrenergic blocking agents, tetracycline compounds, chloramphenicol, clofibrate, disopyramide, miconazole (oral forms) and cimetidine.

It may be diminished by corticosteroids, oral contraceptives, thiazide diuretics, phenothiazine derivatives, thyroid hormones and abuse of laxatives.

- Hypoglycaemia.

- Abnormalities of hepatic function are not uncommon during DIAMICRON^® therapy. There are rare reports of hepatic failure, hepatitis and jaundice following treatment with DIAMICRON^®.

- Mild gastro-intestinal disturbances including nausea, dyspepsia, diarrhoea, constipation have been reported but this type of adverse reaction can be avoided if DIAMICRON^® is taken during a meal.

- Skin reactions including rash, pruritus, erythema, bullous eruption; blood dyscrasia including anaemia, leukopenia, thrombocytopenia and granulocytopenia have been observed during treatment with DIAMICRON^® but are not known to be directly attributable to the drug.

Servier Laboratories Limited

(POM)

26 June 2009