Each tablet contains 30 mg Gliclazide.
Magnesium Stearate, Calcium hydrogen phosphate, Cellulose, Aerosil.
Gliclazide is a sulphonylurea, oral anti-diabetic agent.
Gliclazide reduces blood glucose levels by stimulating insulin secretion from the β-cells of the islets of Langerhans. In addition to these metabolic properties, gliclazide has haemovascular properties.
Effects on insulin release: In type 2 diabetics, gliclazide restores the first peak of insulin secretion in response to glucose and increases the second phase of insulin secretion.
Haemovascular properties: Gliclazide decreases microthrombosis which may be involved in complications of diabetes.
Absorption: Gliclazide is completely absorbed. Food intake does not affect the rate or degree of absorption.
Distribution: Plasma protein binding is approximately 95%.
Elimination: Gliclazide is mainly metabolised in the liver and excreted in the urine, the elimination half-life of gliclazide varies between 12 and 20 hours.
Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.
Posology and method of administration:
The daily dose may vary from 30 to 120 mg per day 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.
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 to gliclazide 30mg, 60 mgsustained release tablets:1 tablet of gliclazide 80 mg is comparable to 1 tablet of Gliclazide 30 mg sustained -release. Consequently, the switch can be performed provided careful blood monitoring is undertaken.
Switching from another oral anti-diabetic agent to Gliclazide: Gliclazide 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 Gliclazide.
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 aprolonged 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 Gliclazide, i.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: Gliclazide can be given in combination with biguanides, alpha glucosidase inhibitors or insulin. In patients not adequately controlled with Gliclazide, concomitant insulin therapy can be initiated under close medical supervision.
Older people (over 65 years of age): Gliclazide should be prescribed using the same dosing regimen recommended for patients under 65 years of age.
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 hypoglycaemia: There is an increased risk of hypoglycaemia in the following circumstances:
It is recommended that the minimum daily starting dose of 30 mg is used.
Paediatric population: The safety and efficacy of Gliclazide in children and adolescents has not been established.
Warnings and precautions:
Some cases of Hypoglycaemia may be severe and prolonged. Hospitalisation may be necessary and glucose administration may need to be continued for several days.
Factors which increase the risk of hypoglycaemia:
Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when one of the following drugs is taken: Other anti-diabetic agents, beta-blockers; fluconazole; angiotensin converting enzyme inhibitors ,H2-receptor antagonists; monoamine oxidase inhibitors (MAOIs); sulphonamides; clarithromycin; and non-steroidal anti-inflammatory agents.
Ritodrine, salbutamol and terbutaline (I.V. administration): increased blood glucose levels due to beta-2 agonist effects. The importance of monitoring blood glucose levels should be emphasised. If necessary, switch to insulin.
Anticoagulant therapy (e.g. warfarin): Sulphonylureas may lead to potentiation of anticoagulation during concurrent treatment. Adjustment of the anticoagulant may be necessary.
There is no experience with the use of gliclazide during pregnancy in humans. Control of diabetes should be obtained before the time of conception to reduce the risk of congenital abnormalities linked to uncontrolled diabetes.
Oral hypoglycaemic agents are not suitable. Insulin is the drug of first choice for treatment of diabetes during pregnancy. It is recommended that oral hypoglycaemic therapy is changed to insulin before a pregnancy is attempted, or as soon as pregnancy is discovered.
It is not known whether gliclazide or its metabolites are excreted in breast milk. Given the risk of neonatal hypoglycaemia, gliclazide is contra-indicated in breast-feeding mothers.
Effects on ability to drive and use machines:
gliclazide has no known influence on the ability to drive and use machines. However, patients should be made aware of the symptoms of hypoglycaemia and should be careful if driving or operating machinery, especially at the beginning of treatment.
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:
The following adverse events have been described for other sulphonylureas: Erythrocytopenia, agranulocytosis, haemolytic anaemia, pancytopenia, allergic vasculitis, hyponatraemia, elevated liver enzyme levels and even impairment of liver function and hepatitis, which regressed after withdrawal of the sulphonylurea or led to life-threatening liver failure in isolated cases.
An overdose of sulphonylureas may cause hypoglycaemia. Moderate symptoms of hypoglycaemia, without any loss of consciousness or neurological signs, must be corrected by carbohydrate intake, dose adjustment and/or change of diet. Strict monitoring should be continued until the doctor is sure that the patient is out of danger.
Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible and must be treated as a medical emergency, requiring immediate hospitalisation.
Dialysis is of no benefit to patients due to the strong binding of gliclazide to proteins.