Qaialdo · 4.8 Undesirable effects · 1

HOS-288223 · has-adverse-reaction-information · PDF-Seite 8

Summary of the safety profile The most frequent adverse reactions of spironolactone include: hyperkalaemia, reported in 17.5% of patients, particularly in patients with renal impairment or if receiving ACE-inhibitors or angiotensin II antagonists concomitantly; gynaecomastia and breast pain, reported in 9% of males. The following undesirable effects have been observed in clinical trials and reported during treatment with spironolactone with the following frequencies: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data). Table 2 presented below is according to the MedDRA system organ classification and frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 8 Table 2 Tabulated list of adverse reactions System organ class Frequency Adverse reactions Neoplasms benign, malignant Uncommon Benign breast neoplasm (male) and unspecified (including cysts and polyps) Blood and lymphatic system Not known Leukopenia, disorders Agranulocytosis, Thrombocytopenia, Anaemia, Eosinophilia Purpura Metabolism and nutrition Very common Hyperkalaemia*** disorders Uncommon Electrolyte imbalance Psychiatric disorders Common Confusional state Not known Libido disorder Nervous system disorders Common Dizziness Not known Ataxia, Headache, Drowsiness, Lethargy Gastrointestinal disorders Common Nausea

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HOS-288219 · has-contraindication-information · PDF-Seite 5

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 - In paediatric patients with moderate (GFR 30 - < 60 ml/min) to severe renal impairment (GFR < 30 ml/min) - Addison’s disease - Hyperkalaemia (> 5.5 mEq/L) - Concomitant use of eplerenone. Spironolactone should not be administered concurrently with other potassium-conserving diuretics and potassium supplements should not be given routinely with spironolactone as hyperkalaemia may be induced.

HOS-288218 · has-indication-information · PDF-Seite 2

In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. Neonates, children and adolescents should only be treated under guidance of a paediatric specialist. There is limited paediatric data available (see sections 5.1 and 5.2).

HOS-288221 · has-interaction-information · PDF-Seite 7

Interactions affecting the use of this medicinal product Interactions affecting the potassium homeostasis Concomitant use of medicinal products known to cause hyperkalaemia (such as lisinopril, valsartan, indometacin) with spironolactone may result in severe hyperkalaemia. In addition, concomitant use of trimethoprim/sulfamethoxazole (co-trimoxazole) with spironolactone may result in clinically relevant hyperkalaemia. Since ACE inhibitors decrease aldosterone production, they should not routinely be used with spironolactone, particularly in patients with marked renal impairment. Hyperkalaemic metabolic acidosis has been reported in patients given spironolactone concurrently with ammonium chloride or colestyramine. Interactions attenuating the natriuretic effect of spironolactone Non-steroidal anti-inflammatory medicinal products such as acetylsalicylic acid, indometacin and mefenamic acid may attenuate the natriuretic efficacy of diuretics due to the inhibition of intra-renal synthesis of prostaglandins and have been shown to attenuate the diuretic effect of spironolactone. Interactions affecting the use of other medicinal products Concurrent use with carbenoxolone should be avoided. 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, and then adjusted as necessary. Concomitant administration with cardiac glycosides may necessitate adjustment of the doses of these medicinal products. Spironolactone has been shown to increase the half-life of digoxin. Spironolactone has been reported to increase serum digoxin concentration and to interfere with certain serum digoxin assays. In patients receiving digoxin and spironolactone the digoxin response should be monitored by means other than serum digoxin concentrations, unless the digoxin assay used has been proven not to be affected by spironolactone therapy. If it proves necessary to adjust the dose of digoxin, patients should be carefully monitored for evidence of enhanced or reduced digoxin effec

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HOS-288222 · has-pregnancy-information · PDF-Seite 8

Pregnancy There are no studies of spironolactone in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Qaialdo is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding Canrenone is excreted in human milk. Qaialdo should not be used during breast-feeding. Fertility Studies in animals suggest spironolactone may impair fertility (see section 5.3).

HOS-288220 · has-warning-information · PDF-Seite 5

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 precarious. Concomitant use of spironolactone with other potassium sparing diuretics, angiotensin- converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory medicinal products, angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin or other medicinal 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 is normal. Dilution hyponatraemia may occur in combination with other diuretics (see section 4.5). 5 Hyperkalaemia in patients with severe heart failure Hyperkalaemia may be fatal. It is critical to monitor and manage serum potassium in patients with severe heart failure receiving spironolactone. Avoid using other potassium-sparing diuretics. Avoid using oral potassium supplements in patients with serum potassium > 3.5 mEq/L. The recommended monitoring for potassium and creatinine is 1 week after initiation or increase in dose of spironolactone, monthly 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 > 350 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). Ure

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