GlibenHEXAL

GlibenHEXAL is a hypoglycaemic agent indicated in the treatment of non-insulin dependent diabetes in patients who respond inadequately to dietary measures alone.

Treatment of previously untreated diabetes:

Stabilisation can be started with one 5mg tablet daily with or immediately after breakfast or the first main meal. If control is satisfactory one tablet is continued as the maintenance dose. If control is unsatisfactory, the dose can be adjusted by increments of 2.5 or 5mg at weekly intervals. The total daily dosage rarely exceeds 15mg and increasing the daily dosage above this does not generally produce any additional effect.

The total daily requirement should normally be given as a single dose at breakfast, or with the first main meal. The patient's diet and activity should be taken into account.

Children: GlibenHEXAL is not recommenced for use in children.

In debilitated patients who may be more liable to hypoglycaemia, treatment should be initiated with one 2.5mg tablet daily.

Changeover from other sulphonylureas:

The changeover to GlibenHEXAL from other drugs with similar mode of action can be carried out without any break in therapy.

Treatment is commenced with the equivalent dose of GlibenHEXAL without exceeding an initial dose of 10mg. If response is inadequate, the dose can be raised in a stepwise fashion to 15mg daily. One 5mg tablet of GlibenHEXAL is approximately equivalent to 1g tolbutamide or glymidine, 250mg chlorpropamide or tolazamide, 500mg acetohexamide, 25mg glibornuride or 5mg glipizide.

Changeover from biguanides: The biguanide should be withdrawn and GlibenHEXAL treatment started with one 2.5mg tablet. The dosage should then be adjusted by increments of 2.5mg to achieve control.

Combination with biguanides: If adequate control is not possible with diet and 15mg of GlibenHEXAL, control may be established by combined administration of GlibenHEXAL and a biguanide derivative.

Changeover from insulin:

While it is appreciated that most patients who are on insulin therapy will continue to need it, there may be a few patients, particularly those on low daily doses, who will remain stabilised if transferred from insulin to GlibenHEXAL.

Known hypersensitivity to GlibenHEXAL or to any of the excipients

Patients known to have sensitivity to other sulphonylureas and related drugs

Juvenile onset diabetes

Diabetic ketoacidosis.

Severe infection, stress, trauma, surgical procedures or other severe conditions where the drug is unlikely to control the hyperglycaemia.

Severe impairment of renal function.

Hepatic impairment.

Diabetic coma and pre-coma.

Porphyria

Pregnancy

Elderly (> 70 years).

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 overdose.

- When calorie or glucose intake is insufficient

- In patients with irregular mealtimes and/or missed meals

- During excessive exercise

- In debilitated patients

- In patients with mild to moderate renal impairment. However, in long-term clinical trials patients with renal insufficiency have been treated satisfactorily using GlibenHEXAL at reduced doses with careful patient monitoring.

- In patients with adrenal or pituitary insufficiency

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 adjust the dose of GlibenHEXAL according to the blood glucose response and to the 24 hour urinary glucose during the first days of treatment

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

None (unless there is a risk of hypoglycaemia).

Immune system disorders

Hypersensitivity reactions:

- Rash, urticaria, erythema multiforme, erythema nodosum, bullous eruptions, pruritus, exfoliative dermatitis, photosensitivity

- Altered liver enzymes values, hepatitis and cholestatic jaundice.

- Blood dyscrasias including agranulocytosis, aplastic and haemolytic anaemia, pancytopenia, leucopenia, thrombocytopenia and neutropenia

- Fever

- Stevens-Johnson syndrome

Hypersensitivity reactions affecting the skin usually occur within the first six weeks of treatment with a sulphonylurea.

Metabolism and nutrition disorders

Hypoglycaemia.

Syndrome of inappropriate secretion of antidiuretic hormone, characterised by water retention and hyponatraemia.

Gastrointestinal disorders

Nausea, heartburn, anorexia, and diarrhoea. This type of adverse reaction can be avoided if GlibenHEXAL is taken during a meal. Vomiting, metallic taste, increased appetite and weight gain.

Hepatic Disorders

Intrahepatic cholestasis and acute hepatitis-like syndrome.

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 at www.mhra.gov.uk/yellowcard.

Symptoms: hypoglycaemia.

Treatment:

- Patient should be transferred to hospital

- Activated charcoal to be administered

- Hypoglycaemia should be treated with urgency by appropriate means

- Vital signs should be monitored and appropriate supportive measures used, including the treatment of cerebral oedema should this occur

- Observation should continue for several days in case hypoglycaemia is prolonged or recurs.

GlibenHEXAL is an orally active hypoglycaemic agent, which acts by stimulating insulin secretion.

GlibenHEXAL is rapidly absorbed and is extensively bound to plasma proteins, but is not readily displaced by acidic drugs. It is excreted as metabolites in the urine and bile.

There are no pre-clinical data of any relevance to the prescriber, which are additional to those already included in other sections.

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