Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Bumetanide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Bumetanide belongs to a group of medicines called diuretics (or 'water' tablets). Diuretics act on the kidneys to increase the flow of urine. This gets rid of excess water from your body and reduces the effect of water build up. Bumetanide can be used to help get rid of excess water in your body, which may be caused by medical problems such as heart failure, liver or kidney disease. 2.
e Bumetanide
Do not take Bumetanide if you:
•
if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Bumetanide or other sulphonamides, e.g., loop diuretics.
Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with Bumetanide treatment. Stop using Bumetanide and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. During treatment Whilst taking this medicine, you may need to have blood tests, as advised by your doctor, to check levels of certain salts in the blood. Other medicines and Bumetanide Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take Bumetanide with:
Bumetanide
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. At the start of treatment your doctor may monitor your condition closely.
Adults The usual recommended starting dose is 1 mg a day. This dose can be taken in the morning or early evening. In some cases an additional 1 mg may be given 6 to 8 hours after your first dose. If your condition is not controlled by a lower dose, or you are being treated for a severe build-up of fluid (oedema), you may need to take up to 5 mg a day. If there is still no response, your doctor may increase your dose until your fluid build up is controlled. If you are taking more than one tablet a day it may be recommended that you take one dose in the morning and one dose in the early evening. Elderly Your doctor may adjust your dose to make sure the dose is right for you. Use in children Bumetanide is not recommended for use in children under 12 years old. If you take more Bumetanide than you should Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. If you forget to take Bumetanide Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose. If you keep forgetting to take your medicine, tell your doctor. If you stop taking Bumetanide Do not suddenly stop taking your medicine unless your doctor told you. If you stop taking this medicine, the fluid build-up in the body may return. Therefore, before you stop taking bumetanide, talk to your doctor or pharmacist for advice. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Bumetanide and seek medical attention immediately if you notice any of the following symptoms: • • • •
difficulty breathing (which may feel like an asthma attack), raised, red very itchy skin rash (hives) or an itchy, runny nose. These may be signs of an allergic reaction. in people with liver problems, due to a build-up of potentially harmful substances in the body, confusion, drowsiness and difficulty performing normal tasks such as writing may occur. In some instances, this may lead to a loss of consciousness (coma). passing little or no urine. reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome, toxic epidermal necrolysis].
Other side effects are: Common (may affect up to 1 in 10 people):
• • • • •
headache low blood pressure, which can make you feel dizzy especially when standing up
feeling sick in people with liver problems, itching of the skin feeling unusually tired
Uncommon (may affect up to 1 in 100 people):
Bumetanide
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
What Bumetanide contains The active substance is bumetanide. Each tablet contains either 1 mg or 5 mg of bumetanide. The other ingredients are lactose monohydrate, maize starch, pregelatinised maize starch, microcrystalline cellulose and magnesium stearate. What Bumetanide looks like and contents of the pack Your medicine is available in two strengths 1 mg and 5 mg, both are a white tablet. The 1 mg tablets are marked 'BU/1' on one side and 'G' on the other and the 5 mg tablets are marked 'BU/5' on one side and 'G' on the other.
Bumetanide is available in blisters and containers of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets. Not all pack sizes and pack types may be marketed. Marketing Authorisation Holder Viatris, Station Close, Potters Bar, EN6 1TL, United Kingdom. Manufacturer Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Hungary This leaflet was last revised in June 2026.
Bumetanide 5 mg Tablets comes as tablet containing 5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Bumetanide 5 mg Tablets is bumetanide.
This leaflet reproduces the patient information leaflet approved for Bumetanide 5 mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Bumetanide is indicated for the treatment of oedema associated with e.g. congestive heart failure, renal dysfunction including nephrotic syndrome and cirrhosis of the liver in adults.
In oedema of renal or cardiac origin where high doses of a potent short - acting diuretic are required, Bumetanide 5 mg may be used in adults.
Posology
Adults: The dose should be carefully titrated in each patient according to the patient's response and the required therapeutic activity. As a general rule, in patients not controlled on lower doses, dosage should be started at 5mg daily and then increased by 5mg increments every 12-24h until the required response is obtained or until side effects appear. Consideration should be given to a twice daily rather than a once daily dosage.
Direct substitution of bumetanide for furosemide in a 1:40 ratio at high doses should be avoided. Treatment should be initiated at a lower equivalent dose and gradually increased at 5 mg increments.
Dosage in the elderly
Adjust the dosage according to the response. A dose of 0.5 mg bumetanide per day may be sufficient in some elderly patients.
Paediatric population
Not recommended for children under 12 years of age as there is limited information on safety, efficacy and dosage in children.
Method of administration
For oral use.
Hypersensitivity to the active substance, sulfonamides or to any of the excipients listed in section 6.1.
Oliguria.
Anuria.
Increase in blood urea.
• Although bumetanide can be used to induce diuresis in renal insufficiency, any marked increase of blood urea or the development of oliguria or anuria during treatment of severe progressive renal disease are indications for stopping treatment with bumetanide.
Hepatic coma.
Severe electrolyte imbalance.
Concomitant administration with lithium salts (see section 4.5).
Sudden changes in cardiovascular pressure-flow relationships, leading to circulatory collapse, can occur particularly in the elderly if the oedema is eliminated too rapidly. It is important to remember this when bumetanide is given in high doses, either orally or intravenously.
Patients with chronic renal failure on high doses of bumetanide should remain under constant hospital supervision.
Patients on a low salt diet may suffer electrolyte imbalance. Serum electrolyte checks, in particular for sodium, potassium, chloride and bicarbonate, should be carried out on a regular basis and, where necessary, replacement therapy carried out.
Bumetanide may enhance the nephrotoxicity or ototoxicity of other drugs, particularly in patients with renal impairment.
Bumetanide may precipitate encephalopathy in patients with hepatic impairment.
Bumetanide may increase uric acid. Blood glucose and blood uric acid should be measured periodically, especially in diabetics and those suspected of latent diabetes and in patients with gout.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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. Patients should be advised of the signs and symptoms of SJS and TEN and closely monitored for those. If signs and symptoms suggestive of these reactions appear, bumetanide should be withdrawn, and an alternative therapy should be considered. If the patient has developed a serious reaction such as SJS or TEN, with the use of bumetanide, treatment with bumetanide must not be restarted in this patient at any time.
The following combinations with bumetanide are considered potentially hazardous:
Bumetanide should not be administered concurrently with lithium, as diuretics reduce the clearance rate of lithium leading to increased blood-lithium levels with signs of overdose (see section 4.3).
When bumetanide is used to treat oedema in hypertensive patients the dose of antihypertensive drug may need to be adjusted as bumetanide may potentiate its effects.
The dose of bumetanide may need to be adjusted when given in conjunction with cardiac glycosides, such as digitalis, since the increased potassium excretion resulting from bumetanide administration can cause an increased sensitivity of the myocardium to the toxic effects of glycosides.
Certain NSAIDS are known to have antagonistic effects on the action of diuretics.
Bumetanide should not be given concurrently with certain antibiotics and antifungals, such as cephaloridine or amphotericin as it could lead to increased toxic effects from these antibiotics and antifungals.
Pregnancy
Although tests in animals have shown no teratogenic effects, there are no data on its effect on pregnant humans. Therefore it is advisable to avoid taking this drug during the first trimester.
Breast-feeding
There are no data on breast-feeding and therefore nursing mothers should stop bumetanide treatment during breast-feeding unless the drug is essential. In such cases, the infant should be observed for any adverse effects.
Bumetanide has no known effect on the ability to drive or operate machinery.
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), have been reported in association with bumetanide (see section 4.4).
Adverse effects are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data):
Blood and lymphatic system disorders
Rare: Bone marrow depression associated with the use of bumetanide, but it has not been proven definitely to be attributed to the drug.
Not known: thrombocytopenia.
Metabolism and nutrition disorders
Common: dehydration.
Uncommon: fluid and electrolyte depletion.
Not known: hyperuricaemia, hyperglycaemia.
Nervous system disorders
Common: dizziness, headache.
Not known: encephalopathy (in patients with pre-existing hepatic disease).
Ear and labyrinth disorders
Uncommon: ear pain, vertigo.
Rare: Hearing disturbance after administration of bumetanide, which is reversible.
Vascular disorders
Common: hypotension.
Gastrointestinal disorders
Common: nausea.
Uncommon: diarrhoea.
Not known: stomach cramps, abdominal pain, vomiting, dyspepsia.
Skin and subcutaneous tissue disorders
Common: pruritis (in patients with liver disease).
Not Known: Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN).
Uncommon: urticaria.
Not known: rash.
Musculoskeletal and connective tissue disorders
Not known: muscle cramps, arthralgia.
Reproductive system and breast disorders
Uncommon: painful breasts.
Not known: gynaecomastia.
General disorders and administration site conditions
Common: fatigue.
Uncommon: chest discomfort.
Investigations
Not known: raised blood urea and serum creatinine, abnormalities of serum levels of hepatic enzymes
Higher dose therapy:
In patients with severe chronic renal failure given high doses of bumetanide, there have been reports of severe, generalised musculoskeletal pain sometimes associated with muscle spasm, occurring one or two hours after administration and lasting up to 12 hours. The lowest reported dose causing this type of adverse reaction was 5 mg by intravenous injection and the highest was 75 mg orally in a single dose. All patients recovered fully and there was no deterioration in their renal function. The cause of this pain is uncertain but it may be a result of varying electrolyte gradients at the cell membrane level.
Experience suggests that the incidence of such reactions is reduced by initiating treatment at 5-10 mg daily and titrating upwards using a twice daily dosage regimen at doses of 20 mg or more.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Signs and symptoms
If overdose has occurred or is suspected symptoms should be those caused by excessive diuresis.
Management
Steps should be taken to empty the stomach either by emesis or gastric lavage. General measures should be taken to restore blood volume, maintain blood pressure and correct electrolyte disturbances.
Ask anything about Bumetanide 5 mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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