Amaryl Adverse Reactions



PT. Aventis Pharma
Full Prescribing Info
Adverse Reactions
Based on experience with Amaryl and on what is known of other sulfonylureas, the following adverse effects must be considered: Metabolism and nutrition disorders: As a result of the blood-sugar-lowering action of Amaryl, hypoglycaemia may occur and may also be prolonged. Possible symptoms of hypoglycaemia include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentrations, alertness and reactions, depression, confusion, difficulty in speaking and even speech loss, 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 slow heart rate (bradycardia). In addition, signs of adrenergic counter-regulation may be present such as sweating, clammy skin, anxiety, rapid heart rate (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 disorder: Especially at the start of treatment, temporary visual impairment may occur due to the change in blood sugar levels. The cause is temporary alteration in the turgidity and hence the refractive index of the lens, this being independent on blood glucose level.
Gastrointestinal disorders: Occasionally, gastrointestinal symptoms such as the following may occur: nausea, vomiting, sensations of pressure of fullness in the epigastrium, abdominal pain and diarrhea.
In rare cases, liver enzyme levels may increase. In isolated cases, impairment of liver function (e.g. with cholestasis and jaundice) and hepatitis may develop, leading to liver failure.
Dysgeusia (frequency not known).
Blood and lymphatic system disorders: Severe changes in blood picture may occur: Rarely, thrombocytopenia and, in isolated cases, leucopenia, haemolytic anaemia or e.g. erythrocytopenia, granulocytopenia, agranulocytosis and pancytopenia (e.g. due to myelosuppression) may develop. Cases of severe thrombocytopenia with platelet count less than 10,000/μl and thrombocytopenic purpura have been reported in post-marketing experience (frequency not known).
Skin and subcutaneous tissue disorders: Alopecia (frequency not known).
General disorders: Occasionally, allergic or pseudoallergic reactions may occur, e.g.; in the form of itching, urticaria or rashes (e.g., erythema, morbilliform or maculopapular eruptions), if skin reactions persist, the drug should be discontinued. Such reactions may be mild, but also may become more serious and may be accompanied by dyspnoea and a fall in blood pressure, sometimes progressing to shock. If urticaria occurs, a doctor must be notified immediately. In isolated cases, a decrease in serum, inflammation of blood vessels (allergic vasculitis) and hypersensitivity of the skin to light may occur.
Investigations: Glimepiride, like all sulfonylureas, can cause weight gain (frequency not known).
Consult the doctor if the patient notices any of the adverse effects listed in this package insert or any other undesired effects or unexpected changes. Since some adverse effects (e.g. severe hypoglycaemia, certain changes in blood picture, severe allergic or pseudoallergic reactions, or liver failure) may under certain circumstances become life-threatening, it is essential that, if sudden or severe reactions do occur, inform a doctor at once, and on no account continue taking the drug without a doctor's express guidance.
Further to the previously mentioned adverse effects of Amaryl, the following events have been reported with sulfonylureas: Porphyria cutanea tarda; Hepatic porphyria reaction; Disulfiram-like reaction; Syndrome of inappropriate antidiuretic hormone (SIADH) secretion.
It has been suggested that these sulfonylureas may augment the peripheral action of ADH and/or increase the release of ADH.
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