FRUSOL (Furosemide) Abbreviated Prescribing Information

Abbreviated Prescribing Information: Frusol 20mg/5ml, 40mg/5ml, and 50mg/5ml Oral Solution Consult Summary of Product Characteristics before prescribing. Presentation: 20 mg/5ml: A clear yellow liquid / 40 mg/ 5ml and 50 mg/ 5ml: clear colourless to straw coloured (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 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: Before initiating furosemide, correct any hypotension, hypovolaemia, or severe electrolyte disturbances. Furosemide is not recommended in patients at high risk for radiocontrast nephropathy or elderly patients with dementia taking risperidone due to increased mortality. Use with caution and consider dose adjustments in elderly patients, those with urinary retention risks, liver congestion, diabetes, pregnancy, gout, hepatic or renal impairment, adrenal disease, hypoproteinaemia, acute hypercalcaemia, premature infants, and those with acute porphyria. Monitor for symptomatic hypotension. Avoid concurrent use with NSAIDs, ACE inhibitors, angiotensin II receptor antagonists, and risperidone in elderly dementia patients. Regular monitoring of serum sodium, potassium, renal function, glucose, other electrolytes, lipids, and clinical signs such as blood dyscrasias, liver damage, and idiosyncratic reactions is essential. Excipient warnings include ethanol, liquid maltitol, propylene glycol, and sodium content, with specific precautions for children, pregnant or breastfeeding individuals, and those with hereditary fructose intolerance or alcohol dependency. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. A list of very common, Common and serious adverse reactions : Very common adverse reactions: Dehydration, hyponatraemia, hypochloremic metabolic alkalosis, hypocalcaemia, hypomagnesemia (incidences of the last three are reduced by triamterene), 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. Common adverse reactions: Hypovolaemia, hypochloraemia, creatinine increased, blood urea increased. Serious adverse reactions include: Aplastic anaemia, bone marrow depression, leucopenia, haemolytic anaemia, agranulocytosis, thrombocytopenia, impaired glucose tolerance (by hypokalaemia), hyperglycaemia, tetany, aggravated pre-existing metabolic alkalosis (in decompensated cirrhosis of the liver), excretion of potassium increased [potassium deficiency manifesting as neuromuscular symptoms (muscular weakness, paralysis), renal symptoms (polyuria) or cardiac symptoms (severe potassium depletion can result in paralytic ileus or confusion, which can result in coma)], paraesthesia, confusion, fainting and loss of consciousness (caused by symptomatic hypotension), deafness (sometimes irreversible), cardiac arrhythmias, increased risk or persistence of patent ductus arteriosus in premature infants, vasculitis, thrombosis, shock, acute pancreatitis (in long-term diuretic treatment, including furosemide), pure intrahepatic cholestasis (jaundice), heaptic function abnormal, hepatic encephalopathy in patients with hepatocellular insufficiency, toxic epidermal necrolysis, erythema multiforme, acute generalised exanthematous pustulosis (AGEP), Steven-Johnson’s syndrome, urinary obstruction (in patients with hyperplasia of the prostate, bladder inability to empty, urethral stricture unspecified), interstitial nephritis, acute renal failure, patent ductus arteriosus, severe anaphylactoid or anaphylactic reactions (e.g. with shock). Please refer to summary of product characteristics for full details of adverse reactions. 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. Legal Category: POM. Date of Preparation: [August 2025]