Spironolactone 12.5 mg Film-coated Tablets

Spironolactone is contraindicated in adult and paediatric patients with the following: • acute renal insufficiency, significant renal compromise, anuria • Addison's disease • hyperkalaemia • hypersensitivity to spironolactone or to any of the excipients listed in section 6.1 • concomitant use of eplerenone or other potassium sparing diuretics. Spironolactone is c …

Spironolactone is contraindicated in adult and paediatric patients with the following: • acute renal insufficiency, significant renal compromise, anuria • Addison's disease • hyperkalaemia • hypersensitivity to spironolactone or to any of the excipients listed in section 6.1 • concomitant use of eplerenone or other potassium sparing diuretics. Spironolactone is contraindicated in paediatric patients with moderate to severe renal impairment. Spironolactone should not …

Spironolactone is contraindicated in adult and paediatric patients with the following: • acute renal insufficiency, significant renal compromise, anuria • Addison's disease • hyperkalaemia • hypersensitivity to spironolactone or to any of the excipients listed in section 6.1 …

Spironolactone is contraindicated in adult and paediatric patients with the following: • acute renal insufficiency, significant renal compromise, anuria • Addison's disease • hyperkalaemia • hypersensitivity to spironolactone or to any of the excipients listed in section 6.1 • concomitant use of eplerenone or other potassium sparing diuretics …

Fluid and electrolyte balance Fluid and electrolyte status should be regularly monitored particularly in the elderly, in those with significant renal and hepatic impairment. Hyperkalaemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities which may be fatal. Should hyperkalaemia develop spironolactone should be discontinued, and if necessary, active measures taken to reduce the serum potassium to normal (see section 4.3). Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia has been reported to occur in some patients with decompensated hepatic cirrhosis, even in the presence of nor …

Fluid and electrolyte balance Fluid and electrolyte status should be regularly monitored particularly in the elderly, in those with significant renal and hepatic impairment. Hyperkalaemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities which may be fatal. Should hyperkalaemia develop spironolactone sh …

… ld renal insufficiency because of the risk of hyperkalaemia. (Spironolactone is contraindicated for use in paediatric patients with moderate or severe renal impairment; see section 4.3). Excipients Spironolactone tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

… ld renal insufficiency because of the risk of hyperkalaemia. (Spironolactone is contraindicated for use in paediatric patients with moderate or severe renal impairment; see section 4.3). Excipients Spironolactone tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Fluid and electrolyte balance Fluid and electrolyte status should be regularly monitored particularly in the elderly, in those with significant renal and hepatic impairment. Hyperkalaemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities which may be fatal. Should hyperkalaemia develop spironolactone sh …

… ld renal insufficiency because of the risk of hyperkalaemia. (Spironolactone is contraindicated for use in paediatric patients with moderate or severe renal impairment; see section 4.3). Excipients Spironolactone tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

… egularities which may be fatal. Should hyperkalaemia develop spironolactone should be discontinued, and if necessary, active measures taken to reduce the serum potassium to normal (see section 4.3). Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia has been reported to occur in some patients with decompensated hepatic cirrhosis, even in the presence of normal renal function. Concomitant use of spironolactone with other potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs, angiotensin II antagonists, aldosteron …

Fluid and electrolyte balance Fluid and electrolyte status should be regularly monitored particularly in the elderly, in those with significant renal and hepatic impairment. Hyperkalaemia may occur in patients with impaired re …

… pironolactone has been shown to increase the half-life of digoxin. Spironolactone enhances the metabolism of antipyrine. Spironolactone can interfere with assays for plasma digoxin concentrations. Spironolactone binds to the androgen receptor and may increase prostate specific antigen (PSA) levels in abiraterone-treated prostate cancer patients. Use with abiraterone is not recommended. Spironolactone may reduce mitotane plasma levels in adrenocortical carcinoma patients treated with mitotane and should not be used concomitantly with mitotane.

… eminisation has been observed in male rat fetuses. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Breast-feeding Metabolites of spironolactone have been detected in breast milk. If use of spironolactone is considered essential, an alternative method of infant feeding should be instituted. Fertility Spiron …

… . Breast-feeding Metabolites of spironolactone have been detected in breast milk. If use of spironolactone is considered essential, an alternative method of infant feeding should be instituted. Fertility Spironolactone may induce impotence and menstrual irregularities (see section 4.8).

Pregnancy Spironolactone or its metabolites may cross the placental barrier. With spironolactone, feminisation has been observed in male rat fetuses. The use of spironolactone in pregnant women requires that …

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Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.