Qaialdo 10 mg/ml Oral suspension

… s with the following: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Acute renal insufficiency, severe renal impairment (GFR < 30 ml/min), anuria - Addison's disease - Hyperkalaemia (> 5.5 mEq/L) - Concomitant use of eplerenone. Spironolactone is contraindicated in paediatric patients with moderate (GFR 30 - < 60 ml/min) to severe renal impairment (GFR < 30 ml …

Spironolactone is contraindicated in adult and paediatric patients with the following: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Acute renal insufficiency, severe renal impairment (GFR < 30 ml/min), anuria - Addison's disease - Hyperkalaemia (> 5.5 mEq/L) - Concomitant use of eplerenone. Spironolactone is contraindicate …

Spironolactone is contraindicated in adult and paediatric patients with the following: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Acute renal insufficiency, severe renal impairment (GFR < 30 ml/min), anuria - Addison's disease - …

Spironolactone is contraindicated in adult and paediatric patients with the following: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Acute renal insufficiency, severe renal impairment (GFR < 30 ml/min), anuria - Addison's disease - Hyperkalaemia (> 5.5 mEq/L) - Concomitant use of eplerenone. Spironolactone is contraindicated in paediatric patients with moderate (GFR 30 - < 60 ml/min) to severe renal im …

… y 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 with known effect Sodium benzoate This medicinal product contains 0.75 mg sodium benzoate in each 1 ml which is equivalent to 112.5 mg/150 ml. Increase in bilirubinaemia following its displacement from albumin may increase neonata …

… al products or conditions known to cause hyperkalaemia, potassium supplements, a diet rich in potassium, or salt substitutes containing potassium, may lead to severe hyperkalaemia (see section 4.5). Hyperkalaemia may also occur in patients with impaired renal function. Cardiac dysrhythmias, occasionally fatal, may result. Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia, has been reported to occur in some patients with decompensated hepatic cirrhosis, even when renal function i …

Monitoring fluid and electrolyte state Patients who are being treated with this preparation require regular supervision with monitoring of fluid and electrolyte state. Periodic estimation of serum electrolytes is recommended due to the possibility of hyperkalaemia, hyponatremia and possible transient blood urea nitrogen (BUN) elevation, especially in the elderly and/or in patients with pre-existing impaired renal or hepatic function. The preparation should only be used with particular caution in elderly patients or those with potential obstruction of the urinary tract, or with disorders rendering their electrolyte balance precar …

… deposits in the brain tissue). Sodium This medicinal product contains less than 1 mmol (23 mg) sodium within the recommended dose range, that is to say essentially 'sodium-free'. Sucrose Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. As this medicinal product contains 400 mg sucrose per ml, this has to be taken into consideration in terms of daily intake. This should be taken into account in patients with diabetes mellitus. Qaialdo 10 mg/ml may be harmful to the teeth.

Monitoring fluid and electrolyte state Patients who are being treated with this preparation require regular supervision with monitoring of fluid and electrolyte state. Periodic estimation of serum electrolytes is recommended due to the possibility of hyperkalaemia, hyponatremia and possible transient blood urea nitrogen (BUN) elevation, especially in the elderly and/or in patients with pre-existing impaired renal or hepatic function. The preparation should only be used with particular caution in elderly patients or those with potential obstruction of the urinary tract, or with disorders rendering their electrolyte balance precar …

… for the first 3 months, then quarterly for a year, and then every 6 months. Discontinue or interrupt treatment for serum potassium > 5 mEq/L or for serum creatinine > 353 μmol/L (see section 4.2). Concomitant use with cardiac glycosides or hypotensive agents The concomitant administration of this preparation with cardiac glycosides or hypotensive agents may necessitate adjustment of those medicinal products (see section 4.5). Urea Reversible increa …

… deposits in the brain tissue). Sodium This medicinal product contains less than 1 mmol (23 mg) sodium within the recommended dose range, that is to say essentially 'sodium-free'. Sucrose Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. As this medicinal product contains 400 mg sucrose per ml, this has to be taken into consideration in terms of daily intake. This should be taken into account in patients with diabetes mellitus. Qaialdo 10 mg/ml may be harmful to the teeth.

… ontaining potassium, may lead to severe hyperkalaemia (see section 4.5). Hyperkalaemia may also occur in patients with impaired renal function. Cardiac dysrhythmias, occasionally fatal, may result. Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia, has been reported to occur in some patients with decompensated hepatic cirrhosis, even when renal function is normal. Dilution hyponatraemia may occur in combination with other diuretics (see section 4.5). Hyperkalaemia in patients with severe heart failure Hyperkalaemia may be fatal. It is critical to monitor …

… sibility of hyperkalaemia, hyponatremia and possible transient blood urea nitrogen (BUN) elevation, especially in the elderly and/or in patients with pre-existing impaired renal or hepatic function. The preparation should only be used with particular caution in elderly patients or those with potential obstruction of the urinary tract, or with disorders rendering their electrolyte balance precarious. Concomitant use of spironolactone with other potassium sparing diuretics, angiotensin- converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory medicinal products, angiotensin II antagonis …

Monitoring fluid and electrolyte state Patients who are being treated with this preparation require regular supervision with monitoring of fluid and electrolyte state. Periodic estimation of serum electrolytes is recommended due to the …

… e avoided. Lithium Spironolactone reduces the renal clearance of lithium, thus increasing the risk of lithium toxicity. Monitor lithium levels periodically when spironolactone is coadministered. 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. Potentiation of the effect of other diuretics and antihypertensive medicinal products occurs and their dose may need to be reduced by about 50% when spironolactone is added to the treatment regime, …

… not recommended for the standard therapy for hypertension and oedema during pregnancy. Qaialdo is not recommended during pregnancy and in women of childbearing potential not using contraception. 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. Qaialdo should not b …

… 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 Studies in animals suggest spironolactone may impair 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 …

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