Abbreviated Prescribing Information:

Qaialdo® (spironolactone) 10 mg/ml oral suspension

Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

Presentation: Oral suspension, each 1 ml contains 10 mg spironolactone, 0.75 mg sodium benzoate and 400 mg sucrose.
Indications: For 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.
Dosage and Administration: Congestive heart failure with oedema – usual dose 100 mg/day, may increase to 200 mg/day in difficult cases. Maintenance 75-200 mg/day. Severe heart failure (NYHA Class III-IV) – start at 25 mg/day if serum potassium ≤5.0 mEq/L and creatinine ≤2.5 mg/dL. May increase to 50 mg/day if tolerated. Other indications – refer to SmPC. Elderly: Start with lowest dose and titrate upwards as needed. Use with caution in hepatic/renal impairment. Renal impairment: Start with lowest dose in mild impairment (GFR 60-90 ml/min). Monitor serum potassium and renal function closely. Contraindicated in moderate to severe impairment (GFR <60 ml/min). Hepatic impairment: Start with lowest dose and titrate slowly due to reduced elimination. Monitor for adverse reactions. Paediatric dosing: Neonates: 1-2 mg/kg/day in 1-2 divided doses. Children 1 month to 18 years: 1-3 mg/kg/day in 1-2 divided doses (max 200 mg daily). Two dosing syringes provided (1 ml and 5 ml). Take with food. Shake thoroughly before use. Follow with water.
Contraindications: Hypersensitivity to spironolactone or excipients. Acute renal insufficiency, significant renal compromise (GFR <30 ml/min), anuria. Addison’s disease. Hyperkalaemia (>5.5 mEq/L). Concomitant use of eplerenone. Moderate to severe renal impairment in paediatric patients.
Warnings and Precautions: Regular monitoring of fluid and electrolyte balance required. Risk of severe hyperkalaemia, especially with renal impairment or concomitant medications affecting potassium levels. Monitor serum potassium and creatinine weekly after initiation/dose changes, then monthly for 3 months, quarterly for a year, then 6-monthly. Use with caution in elderly and those with potential urinary obstruction. Risk of metabolic acidosis in decompensated hepatic cirrhosis.
Preclinical Safety Data: Carcinogenic in rats with effects on endocrine organs and liver. Increased incidence of various tumours observed in long-term animal studies. Not mutagenic in bacterial/yeast tests. Mixed results in mammalian tests. May affect fertility and reproductive performance in animals. No teratogenic effects in mice but reduced conception and increased resorption in rabbits.
Excipients: Contains sodium benzoate (0.75 mg/ml) which may increase jaundice in newborns. Contains sucrose (400 mg/ml) – consider in diabetics. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. May be harmful to teeth.
Interactions: Increased risk of hyperkalaemia with ACE inhibitors, angiotensin II antagonists, NSAIDs, potassium supplements and other medications affecting potassium levels. May potentiate effects of other diuretics and antihypertensives. May increase digoxin levels. Avoid concurrent use with potassium-conserving diuretics.
Pregnancy and Lactation: Not recommended during pregnancy. Should not be used during breastfeeding as canrenone is excreted in human milk.
Side Effects: Very common: Hyperkalaemia. Common: Confusional state, dizziness, nausea, pruritus, rash, muscle spasms, acute kidney injury, gynaecomastia, breast pain, malaise. Uncommon: Benign breast neoplasm (male), electrolyte imbalance, hepatic function abnormal, urticaria, menstrual disorder. Other important side effects include blood disorders, GI disorders, skin reactions including Stevens-Johnson syndrome.
Overdose: May cause drowsiness, confusion, nausea, vomiting, dizziness, diarrhoea, skin rash. Risk of dehydration, hyponatraemia or hyperkalaemia. No specific antidote. Treatment includes discontinuation, fluid/electrolyte replacement as needed. For hyperkalaemia: reduce potassium intake, give potassium-excreting diuretics, IV glucose with insulin, or oral ion-exchange resins.
Pack size: 1 glass bottle containing 150 ml Qaialdo (spironolactone) 10 mg/ml oral suspension, 1 adaptor and 2 syringes (1 ml and 5 ml).
Shelf-life: 2 years; 12 weeks after first opening.
Storage: No special storage requirements before opening. After opening keep bottle tightly closed and store below 25°C.
Legal category: POM
Marketing Authorisation Number: PLGB 13581/0006
Marketing Authorisation Holder: Nova Laboratories Limited, Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YL, United Kingdom
Date of latest revision: December 2024
Job number: QaiCHFABVPI001
NHS Price: £247.85
Further information is available from: Nova Laboratories Limited, Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YL, UK. Tel: +44 (0)116 223 0100