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.
None.
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 Gliben 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.
There are no pre-clinical data of any relevance to the prescriber, which are additional to those already included in other sections.
Gliben is an orally active hypoglycaemic agent, which acts by stimulating insulin secretion.
Gliben 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.
None (unless there is a risk of hypoglycaemia).
None
