Abbreviated Prescribing Information: Frusol 20mg/5ml, 40mg/5ml, and 50mg/5ml Oral Solution Consult Summary of Product Characteristics before prescribing. Presentation: A clear yellow liquid (Oral Solution), Each 5ml contains 20 milligrams Furosemide for 20mg/5ml strength, each 5ml contains 40milligrams Furosemide for 40mg/5ml strength and 5ml containing 50 milligrams Furosemide for 50mg/ml strength. Therapeutic Indications: Furosemide is indicated in all conditions requiring prompt diuresis, including cardiac, pulmonary, hepatic and renal oedema, peripheral oedema due to mechanical obstruction or venous insufficiency and hypertension. It is also indicated for the maintenance therapy of mild oedema of any origin. Posology and Method of Administration: For adults the usual initial daily dose is 40mg. This may be adjusted until an effective dose is achieved. In the elderly, Furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved. For oral administration. Suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. The medication should be administered in the morning to avoid nocturnal diuresis. Paediatric population: For paediatric population the dose is 1 to 3mg/Kg body weight daily up to a maximum total dose of 40mg/day. Contra-indications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or sulphonamides, sulphonamide derivatives; Hypovolaemia and dehydration (with or without accompanying hypotension); Severe hypokalaemia: severe hyponatraemia; Comatose or pre-comatose states associated with hepatic cirrhosis or encephalopathy; Anuria or renal failure with anuria not responding to furosemide, renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents; Impaired renal function with a creatinine clearance below 30ml/min per 1.73 m2 body surface area; Addison’s disease; Digitalis intoxication; Concomitant potassium supplements or potassium sparing diuretics and breast-feeding women. Special Warnings and Precautions for use: Hypotension; Hypovolaemia; Furosemide is not recommended in patients at high risk for radiocontrast nephropathy – it should not be used for diuresis as part of the preventative measures against radiocontrast-induced nephropathy and in elderly patients with dementia taking risperidone – Increased mortality. Caution and/or dose reduction required in elderly patients, difficulty with micturition including prostatic hypertrophy (increased risk of urinary retention: consider lower dose). Closely monitor patients with partial occlusion of the urinary tract, in moderate liver congestion dosage adjustment may be needed, diabetes mellitus (latent diabetes may become overt: insulin requirements in established diabetes may increase stop furosemide before a glucose tolerance test), pregnancy, gout (furosemide may raise uric acid levels/precipitate gout) impaired hepatic function, impaired renal function and hepato-renal syndrome, adrenal disease, hypoproteinemia e.g. nephrotic syndrome, acute hypercalcaemia, premature infants, some diuretics have been considered unsafe in acute porphyria, symptomatic hypotension leading to dizziness, fainting or loss of consciousness can occur in patients treated with furosemide, particularly in the elderly, patients on other medications which can cause hypotension and patients with other medical conditions that are risks for hypotension. concurrent NSAIDs should be avoided, ACE-inhibitors & Angiotensin II receptor antagonists – severe hypotension may occur, concurrent risperidone in elderly patients with dementia has resulted in increased mortality. Laboratory and other monitoring requirements: Serum sodium particularly in the elderly or in patients liable to electrolyte deficiency, Serum potassium particular in patients with cirrhosis of the liver, those receiving concomitant treatment with corticosteroids, those with an unbalanced diet and those who abuse laxatives. If used in premature infants there is a risk of nephrocalcinosis /nephrolithiasis so renal function must be monitored and renal ultrasonography performed. Regular monitoring of blood glucose levels is desirable, during long-term therapy (especially at high doses) magnesium, calcium, chloride, bicarbonate and uric acid should be regularly measured. Regular monitoring for blood dyscrasias. If these occur, stop furosemide immediately, liver damage, idiosyncratic reactions. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: POM. A list of common and very common adverse reactions (Refer the SmPC for full details of other adverse reactions): dehydration, hyponatraemia, hypochloremic metabolic alkalosis, hypocalcaemia, hypomagnesemia (incidences of the last three are reduced by triamterene), Hypovolaemia, hypochloraemia, hypotension, (which, if pronounced may cause signs and symptoms such as impairment of concentration and reactions, light-headedness, sensations of pressure in the head, headache, drowsiness, weakness, disorders of vision, dry mouth, orthostatic intolerance), nephrocalcinosis in infants, creatinine increased, blood urea increased. Pack Size and NHS Price: 20mg/5ml 150ml – £12.07, 40mg/5ml 150ml – £15.58, 50mg/5ml 150ml – £16.84. Marketing Authorisation Number: PL 00427/0109, PL 00427/0110, PL 00427/0111 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [January 2023].