Based on the experience with gliclazide and with other sulfonylurea, the following adverse reactions have to be mentioned.
As for other sulfonylureas, treatment with Diamicron MR 60 mg 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 sulfonylurea 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 Adverse Reactions:
Gastrointestinal disturbances, including abdominal pain, nausea, vomiting, dyspepsia, diarrhoea and constipation have been reported: If these should occur, they can be avoided or minimised if gliclazide is taken with breakfast.
The following adverse reactions have been more rarely reported: Skin and Subcutaneous Tissue Disorders:
Rash, pruritus, urticaria, erythema, maculopapular rashes, bullous reactions.
Blood and Lymphatic System Disorders:
Changes in haematology are rare. They may include anaemia, leucopenia, thrombocytopenia, granulocytopenia. These are in general reversible upon discontinuation of medication.
Raised hepatic enzyme levels (AST, ALT, alkaline phosphatase), hepatitis (isolated reports). Discontinue treatment if cholestatic jaundice appears.
These symptoms usually disappear after discontinuation of treatment.
Transient visual disturbances may occur especially on initiation of treatment, due to changes in blood glucose levels.
Class Attribution Effects:
Cases of erythrocytopenia, agranulocytosis, haemolytic anaemia, pancytopenia and allergic vasculitis, have been described for other sulfonylurea.
With other sulfonylureas, cases were also observed of elevated liver enzyme levels and even impairment of liver function (eg, with cholestasis and jaundice) and hepatitis which regressed after withdrawal of the sulfonylurea or led to life-threatening liver failure in isolated cases.