| - HypoglycaemiaHypoglycaemia, sometimes prolonged and even life-threatening, may occur as a result of the blood glucose lowering action of Daonil. Possible symptoms of hypoglycaemia include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentration, alertness, and reactions, depression, confusion, speech disorders, aphasia, visual disorders, tremor, pareses, sensory disturbances, dizziness, helplessness, loss of self control, delirium, cerebral convulsions, somnolence and loss of consciousness up to and including coma, shallow respiration and bradycardia.Signs of adrenergic counter-regulation may be present such as sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris and cardiac arrhythmias. The clinical picture of a severe hypoglycaemic attack may resemble that of a stroke. The symptoms of hypoglycaemia nearly always subside when hypoglycaemia is corrected.- Eyes Temporary visual impairment.- Digestive tractGastrointestinal symptoms such as nausea, vomiting, sensations of pressure or fullness in the epigastrium, abdominal pain and diarrhoea may occur. In isolated cases, there may be elevation of liver enzyme levels and even impairment of liver function (e.g. with cholestasis and jaundice and hepatitis which can regress after withdrawal of Daonil, although they may lead to life-threatening liver failure). Treatment with sulphonylureas has been associated with occasional disturbances of liver function and cholestatic jaundice.- BloodPotentially life-threatening changes in the blood picture may occur. They may include rarely mild to severe thrombopenia (e.g. presenting as purpura), - isolated cases haemolytic anaemia, erythrocytopenia, leucopenia, granulocytopenia, agranulocytosis and (e.g. due to myelosupression) pancytopenia.- General disordersOccasionally, allergic or pseudoallergic reactions may occur, e.g. in the form of itching or rashes. In isolated cases, mild reactions in the form of urticaria may develop into serious and even life-threatening reactions with dyspnoea and fall in blood pressure, sometimes progressing to shock. In the event of urticaria, a physician must therefore be notified immediately.A hypersensitivity reaction may be directed against glibenclamide itself, but may alternatively be triggered by excipients. Allergy to sulphonamide derivatives may also be responsible for an allergic reaction to glibenclamide.In isolated cases, allergic vasculitis may arise and, in some circumstance, may be life threatening. In isolated cases, hypersensitivity of the skin to light may occur, and sodium concentration in the serum may decrease.|
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: firstname.lastname@example.org.