Bumetanide Oral Solution Abbreviated Prescribing Information

Abbreviated Prescribing Information: Bumetanide 0.2 mg/ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: Bumetanide oral solution is a clear, green liquid with the flavour of peppermint. Each ml contains 0.2 mg bumetanide. Therapeutic Indications: Bumetanide oral solution is indicated whenever diuretic therapy is required in the treatment of oedema. Posology and Method of Administration: For oral administration only and the dosage should be adjusted according to the patient’s response. In Adults, adolescents, and children aged 12 years and older, usually 1 mg (5 ml) as a single oral dose given morning or early evening and a dose of 0.5 mg bumetanide per day may be sufficient in some elderly patients. Paediatric population: Bumetanide Liquid should not be used for children under 12 years of age. Contra-indications: Bumetanide oral solution is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, hepatic coma, and marked increase in blood urea or the development of oliguria or anuria during treatment of severe progressing renal disease. Special Warnings and Precautions for use: Excessively rapid mobilisation of oedema particularly in elderly patients may give rise to sudden changes in cardiovascular pressure flow relationships with circulatory collapse. This should be borne in mind when bumetanide is given in high doses. Caution should be exercised in patients with the following: taking a low salt diet, diabetics and patients suspected of latent diabetes, chronic renal failure on high doses of bumetanide, hypotension and porphyria, hepatic impairment, patients already receiving nephrotoxic or ototoxic drugs, and known hypersensitivity to sulfonamides or thiazides. Toxic epidermal necrolysis (TEN) and Stevens Johnson syndrome (SJS), which can be life-threatening or fatal, have been reported in relation to non-antibiotic sulphonamide containing products, including bumetanide. Symptoms of SJS and TEN should be closely monitored and if there are symptoms bumetanide should be withdrawn, and an alternative therapy should be considered. If the patient has developed a serious reaction such as SJS or TEN treatments with bumetanide must not be restarted in this patient at any time. Bumetanide found in urine by doping test is cause for disqualification of athletes. Excipient warnings: Bumetanide contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, sorbitol, and less than 1 mmol sodium in each 5 ml. Any warning from the MC, CHM CSM or MHRA: N/A. Black Triangle notice: N/A. Undesirable Effects: gout, hyperuricaemia, hyperglycaemia, hypocalcaemia, headache, dizziness, tinnitus, deafness, hypotension, gastrointestinal disorder, nausea, vomiting, diarrhoea, abdominal pain, rash (erythematous, maculo-papular, pustular ), urticaria, dermatitis, photosensitivity reaction, pruritus, myalgia, muscle spasm, arthralgia, , gynaecomastia, breast pain, fatigue, and blood creatinine increased. Serious: thrombocytopenia, leukopenia, bone marrow failure, agranulocytosis, hypersensitivity, electrolyte imbalance, orthostatic hypotension, hypokalaemia, hyponatraemia, dehydration, hypomagnesaemia, alkalosis hypochloraemic, hyperlipidaemia, cholestasis, jaundice, Stevens-Johnson syndrome, toxic epidermal necrolysis, renal failure acute. Consult the SPC for full details of undesirable effects. Pack Size and NHS Price: 150 ml – £279.03. Legal Category: Prescription only medicine. Marketing Authorisation Number: PL 00427/0281. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [Oct-2025].