Aldactone 25 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 …

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. Aldactone should not be ad …

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 diuretic …

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 Aldactone 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 Aldactone should …

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 Aldactone should …

… c irregularities which may be fatal. Should hyperkalaemia develop Aldactone 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 Aldactone with other potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs, angiotensin II antagonists, aldosterone blo …

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 …

… lactone 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. Lithium Spironolactone reduces t …

… ot recommended for the standard therapy for hypertension and oedema during pregnancy. Spironolactone should not be used during pregnancy, unless the potential benefit justifies the potential risk. Breast-feeding Canrenone (a major and active) metabolite of spironolactone, is excreted in human milk. There is insufficient information on the effects of spironolactone in newborns/infants. Spironolactone shoul …

… whether to discontinue breast-feeding or to discontinue/abstain from spironolactone therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility Spironolactone administered to female mice reduced fertility (see Section 5.3).

Pregnancy There are limited data from the use of spironolactone in pregnant women. Studies in animals have shown reproductive toxicity associated with the anti-androgenic effect of spironolactone (see Sectio …

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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.

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.

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