Clinically significant adverse reactions (frequency unknown):
Angioedema: Since angioedema manifested by facial, labial, glossal and laryngopharyngeal swellings may occur, patients should be closely observed. If any abnormality is observed, Volteri Tablets should be discontinued, and appropriate measures should be taken.
Shock, syncope or unconsciousness: Since shock, syncope or unconsciousness due to lowering of blood pressure may occur, close observation should be made. If coldness, vomiting, unconsciousness, etc. are observed, appropriate measures should be immediately taken. Condition of the patients should be closely observed while administration of Volteri Tablets, especially in patients on hemodialysis, those on strict low-salt diets, those taking diuretics, and those with heart failure.
Acute renal failure: Since acute renal failure may occur, patients should be closely observed. If any abnormality is observed, Volteri Tablets should be discontinued, and appropriate measures should be taken.
Hyperkalemia: Since severe hyperkalemia may occur, patients should be closely observed. If any abnormality is observed, appropriate measures should immediately be taken.
Fulminant hepatitis, Hepatic dysfunction or jaundice: Since Fulminant hepatitis, hepatic function disorder associated with increased levels of AST (GOT), ALT (GPT), y-GTP etc., or jaundice may occur, patients should be carefully monitored. If any abnormalities are observed, administration of Volteri Tablets should be discontinued and appropriate measures should be adopted.
Agranulocytosis, white blood cell decreased: Since agranulocytosis and white blood cell decreased may occur, patients should be closely observed. If any abnormality is observed, Volteri Tablets should be discontinued, and appropriate measures should be taken.
Rhabdomyolysis: Since rhabdomyolysis, which is characterized by muscle ache, weakness, increased CK (CPK), and increased blood and urinary myoglobin, may occur, patient should be closely observed. In such a case, administration of Volteri Tablets should be immediately discontinued, and appropriate measures should be taken. In addition, pay attention to the occurrence of acute renal failure due to rhabdomyolysis.
Interstitial pneumonia: Interstitial pneumonia with fever, coughing, dyspnea, abnormal chest X-ray, etc, may occur. In such a case, Volteri Tablets should be discontinued and appropriate measures, such as treatment with an adrenocortical hormone, should be taken.
Hypoglycemia: Since hypoglycemia may occur (liable to occur in patients on diabetic therapy), close observation should be made. If feeling of weakness or hungry, cold sweat, tremor of hands, decreased mental concentration, convulsions, disturbed consciousness, etc. are observed, Volteri Tablets should be discontinued, and appropriate measures should be taken.
Platelet count decreased: Since platelet count decreased may occur, patients should be closely observed. If any abnormality is observed, Volteri Tablets should be discontinued, and appropriate measures should be taken.
Atrioventricular block: Since atrioventricular block (initial symptoms: bradycardia, dizziness etc.) may occur, if any abnormality is observed, Volteri Tablets should be discontinued, and appropriate measures should be taken.
Other adverse reactions: See Table 1.
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