BILXONA

e. 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 the next day. As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbAlc).

Initial dose The recommended starting dose is 30 mg daily (half a 60 mg tablet). 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. The breakability of the Bilxona 60 mg modified-release tablet enables flexibility of dosing to be achieved. One Bilxona 60 mg modified release tablet corresponds to two Bilxona 30 mg modified release tablets.

Switching from gliclazide 80 mg tablets to Bilxona 30mg modified-release tablets 1 tablet of gliclazide 80 mg is comparable to 1 tablet of Bilxona 30 mg modified- release. Consequently, the switch can be performed provided careful blood monitoring is undertaken.

e. half a tablet of 60 mg). Consequently, the switch can be performed provided careful blood monitoring is undertaken. Switching from another oral anti-diabetic agent to Bilxona Bilxona can be used to replace other oral anti-diabetic agents.

The dosage and the half-life of the previous anti-diabetic agent should be taken into account when switching to Bilxona. 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 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. e. a starting dose of 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic response.

Combination treatment with other anti-diabetic agents Bilxona can be given in combination with biguanides, alpha glucosidase inhibitors or insulin. In patients not adequately controlled with Bilxona. concomitant insulin therapy can be initiated under close medical supervision.

Based on the experience with gliclazide and with other sulphonylureas, the following undesirable effects have to be mentioned. Hypoglycaemia As for other sulphonylureas, treatment with gliclazide can cause hypoglycaemia, if meal times are irregular and, in particular, if meals are skipped.

Possible symptoms of hypoglycaemia are: headache, intense hunger, nausea, vomiting, lassitude, sleep disorders, agitation, aggression, poor concentration, reduced awareness and slowed reactions, depression, confusion, visual and speech disorders, aphasia, tremor, paresis, sensory disorders, dizziness, feeling of powerlessness, loss of self-control, delirium, convulsions, shallow respiration, bradycardia, drowsiness and loss of consciousness, possibly resulting in coma and lethal outcome.

In addition, signs of adrenergic counter-regulation may be observed: sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris and cardiac arrhythmia. Usually, symptoms disappear after intake of carbohydrates (sugar).

However, artificial sweeteners have no effect. Experience with other sulphonylureas shows that hypoglycaemia can recur even when measures prove effective initially. If a hypoglycaemic episode is severe or prolonged, and even if it is temporarily controlled by intake of sugar, immediate medical treatment or even hospitalisation is required.

Other undesirable effects Gastrointestinal disturbances, including abdominal pain, nausea, vomiting, dyspepsia, diarrhoea and constipation have been reported. These can be avoided or minimised if gliclazide is taken with a meal. The following undesirable effects have been more rarely reported.

Skin and subcutaneous tissue disorders Rash, pruritus, urticaria, angioedema, erythema, maculopapular rashes, and bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis) Blood and lymphatic system disorders Changes in haematology are rare.

Hypoglycaemia This treatment should be prescribed only if the patient is likely to have a regular food intake (including breakfast). It is important to have a regular carbohydrate intake due to the increased risk of hypoglycaemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate.

Hypoglycaemia is more likely to occur during low-calorie diets, following prolonged or strenuous exercise, alcohol intake or if a combination of hypoglycaemic agents is being used. 8). Some cases may be severe and prolonged. Hospitalisation may be necessary and glucose administration may need to be continued for several days.

Careful selection of patients, of the dose used, and clear patient directions are necessary to reduce the risk of hypoglycaemic episodes. 5) Renal and hepatic insufficiency The pharmacokinetics and/or pharmacodynamics of gliclazide may be altered in patients with hepatic insufficiency or severe renal failure.

A hypoglycaemic episode occurring in these patients may be prolonged, so appropriate management should be initiated. 8), treatment and conditions that predispose to its development, should be explained to the patient and to family members.

The patient should be informed of the importance of following dietary advice, of taking regular exercise, and of regular monitoring of blood glucose levels. Poor blood glucose control Blood glucose control in a patient receiving anti-diabetic treatment may be affected by any of the following: Fever, trauma, infection or surgical intervention.

In some cases, it may be necessary to administer insulin. The hypoglycaemic efficacy of any oral anti-diabetic agent, including gliclazide, is attenuated over time in many patients. This may be due to progression in the severity of the diabetes, or to a reduced response to treatment.

This phenomenon is known as secondary failure, which is distinct from primary failure, when an active substance is ineffective as first-line treatment. Adequate dose adjustment and dietary compliance should be considered before classifying the patient as secondary failure.

1. - Hypersensitivity to other sulphonylureas or sulphonamides - Type 1 diabetes - Diabetic pre-coma and coma, diabetic keto-acidosis - Severe renal or hepatic insufficiency. 6)