Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Bumetanide 0.2 mg/ml Oral Solution
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
for Bumetanide Oral Solution contains bumetanide which is a diuretic (water medicine). It is used where there is too much water in your body. Bumetanide helps your kidneys produce more urine over a short period of time which means that your body can get rid of more water quickly. It is effective for people who have swollen feet and ankles due to fluid which has built up as a result of heart, liver or kidney disease.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. ■ Take your medicine at the same time each day, usually in the morning or early evening; this makes it easier to remember. ■ If you are taking more than 5 ml a day, you may need to take two doses rather than taking all your medicine in one go. Remember that this may be inconvenient if you are going on a long journey or want to go to sleep. ■ You are more likely to need the toilet for about 3 hours after you have taken your medicine. ■ You may like to have a drink of water after taking the medicine. The recommended dose is:
Speak to your doctor if you are not sure why this medicine has been prescribed for you.
Adults, adolescents and children over 12 years: the usual starting dose is 5 ml once a day. Your doctor may change your dose after you have been taking this medicine for a while.
What you need to know before you take it
e Bumetanide Oral Solution
Elderly: you may be given a lower starting dose as you may be more sensitive to this medicine.
There are other reasons why you may need a diuretic.
Do not take Bumetanide Oral Solution: ■ if you are allergic to bumetanide or any of the other ingredients of this medicine (listed in section 6) ■ if you cannot pass water (urine) ■ if you are dehydrated (thirsty with dry skin, dark urine, dry mouth, headache) ■ if you have been told by your doctor that you have low levels of salts in your body. If any of the above apply to you, speak to your doctor or pharmacist. Warnings and precautions Talk to your doctor before taking Bumetanide Oral Solution: ■ if you are on a low salt diet ■ if you have diabetes ■ if you have long-term kidney disease ■ if you have liver disease ■ if you have low blood pressure ■ if you have a condition called porphyria ■ if you have high levels of uric acid in your blood.Your doctor may test your blood for this ■ If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Bumetanide Oral Solution or other sulphonamides, e.g., loop diuretics. ■ if you are an athlete who undergoes urine doping testing. Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with Bumetanide Oral Solution treatment. Stop using Bumetanide Oral Solution and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. Children Do not give this medicine to children under 12 years of age.
Use in children This medicine is NOT suitable for children under 12 years. Patients with severe kidney problems: if you have kidney failure and are taking a high dose of Bumetanide Oral Solution, you will be given this medicine in hospital under special care. Blood tests may be carried out to check how well this medicine is working, particularly in patients taking a low salt diet. Diabetics may have their blood and urine checked. If you take more Bumetanide Oral Solution than you should 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately. 2. Take the bottle and any remaining solution with you so that people can see what you have taken. 3. Do this even if you feel well. If you forget to take Bumetanide Oral Solution If you forget to take a dose, take it as soon as you remember if it is less than 12 hours late. If you are more than 12 hours late taking your medicine, skip the forgotten dose and continue as usual. Do not take a double dose to make up for a forgotten dose. If you stop taking Bumetanide Oral Solution Do not stop taking this medicine, or lower the dose yourself, without first checking with your doctor. Keep taking the solution until your doctor tells you to stop. Do not let yourself run out of medicine especially over the weekend or on holidays. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Other medicines and Bumetanide Oral Solution Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines such as:
Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects.You may not experience any of them.
lithium, used for mental illnesses.To help stop side effects your doctor may need to change the dose of your lithium and check the amount of lithium in your blood aminoglycoside antibiotics (e.g. gentamicin) or other medicines which may affect your hearing cardiac glycosides (e.g. digoxin), used to treat heart conditions medicines for high blood pressure non-steroidal anti-inflammatory medicines (e.g. indometacin) medicines which may affect your kidneys.
STOP taking the solution and seek medical help immediately if you have any of the following allergic reactions: ■ difficulty breathing or swallowing, swelling of the face, lips, tongue or throat ■ severe itching of the skin, with a red rash or raised lumps. ■ 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].
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Pregnancy, breast-feeding and fertility DO NOT take Bumetanide if you are pregnant or while breast-feeding unless advised to by your doctor. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Driving and using machines Bumetanide Oral Solution may cause dizziness or tiredness. If this occurs do not drive, use machinery, or perform any tasks that may require you to be alert. Bumetanide Oral Solution contains: Sorbitol This medicine contains 1375 mg sorbitol in each spoonful (5 ml) which is equivalent to 275 mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
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Seek immediate medical attention if you have any of the following symptoms: ■ feeling shaky, faint, or your heart starts to beat fast or irregularly. This may be due to a shock-like reaction ■ fever, rash, feeling sick, aches and pains, loin pain, passing more or less urine than usual, passing red urine or passing urine at night, difficulty or inability to pass urine.This may be due to changes in your kidneys ■ unusual or increased bleeding or bruising ■ fever, sore throat, mouth ulcers, repeated infections or infections that will not go away ■ feeling tired, breathless and looking pale ■ yellowing of your skin or eyes, pale faeces and dark urine, itchy skin.This may be due to blockage in the liver. Tell your doctor if you get any of the following side effects: pain in your bones and muscles.This may happen if you are taking high doses and have severe kidney problems ■ pain and swelling in one or more joints (gout) ■ feeling thirsty with dry skin, dark urine, dry mouth, headache. This may be due to dehydration ■ light-headedness or dizziness when standing up from a sitting or lying position ■
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JOB INFORMATION
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Date:
27.09.2024 Operator:
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PRINT VERSION:
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Product Name:
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Bumetanide 0.2 mg/ml Oral Solution
Dimensions: 420 x 210 mm
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0.2 mg/ml 150ml Bottle Size: 150ml Design Icon: N/A
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reactions to the sun.Your skin may become red, painful and swollen – do not sunbathe, use a sun bed, or expose your skin to UV light a collection of symptoms including thirst, frequent urination, tiredness, and increased susceptibility to infections, such as thrush.This may be due to too much glucose in the body.Your doctor can test for this.
The following side effects usually settle without changing the dose: headache stomach ache, feeling sick or being sick, diarrhoea muscle cramps or pain itchy raised skin (hives) itching skin, skin rashes including dermatitis swollen or painful breasts (sometimes in men) ringing or buzzing in the ears (tinnitus), deafness dizziness feeling tired.
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Blood tests: tell your doctor if you are having blood tests as your medicine may cause changes in the level of some substances in your blood (including salts, sugar, waste-products and body fats such as cholesterol and triglycerides). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRAYellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Bumetanide Oral Solution 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 bottle label and on the carton after EXP.The expiry date refers to the last day of that month. Store below 25°C. 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.
Contents of the pack and other information
What Bumetanide Oral Solution contains ■ The active substance is bumetanide. 5 ml oral solution contains 1 mg bumetanide. ■ The other ingredients are sorbitol (E 420), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum, sodium citrate, patent Blue V, quinoline yellow, peppermint flavour and purified water. (See end of Section 2 for further information on sorbitol, methyl parahydroxybenzoate and propyl parahydroxybenzoate). What Bumetanide Oral Solution looks like and contents of the pack Bumetanide Oral Solution is a clear, green liquid with the flavour of peppermint. It is available in amber glass bottles of 5 ml, 10 ml, 25 ml and 150 ml. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Rosemont Pharmaceuticals Ltd,Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Manufacturer Delpharm Bladel BV, Industrieweg 1, 5531 AD Bladel,The Netherlands. This leaflet was last revised in September 2024.
31000938.11 U7AD1RBJ3 V2
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50
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70
80
90
100
JOB INFORMATION
ARTWORK VERSION:
2
Date:
27.09.2024 Operator:
SFA
PRINT VERSION:
JOB SPECIFICATION
APPROVALS
Product Name:
Keyline Ref:
Bumetanide 0.2 mg/ml Oral Solution
Dimensions: 420 x 210 mm
EAN Code: N/A
Folded Size: 28 x 210 mm
No. of Colours: 1
Tabbed:
Page Number: 2 of 2
Strength:
New Item Code:
Pack Size:
Previous Item Code:
0.2 mg/ml 150ml Bottle Size: 150ml Design Icon: N/A
Date:
COLOURS
Operator:
Print Colours: Black
Supplier Code: Change Control No.:
U7AD1RBJ3 U7AD1RBJ2 31000938.11 CR-01211
Pharmacode:
UKL518
N/A
N/A
MAIN BODY TEXT Font Type:
Font Size:
Univers Roman Univers Bold
9 pt TECHNICAL NON PRINTING COLOURS
Third Party Approval Name: Sign: Date: Regulatory Approval Name: Sign:
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Frequently asked questions about Bumetanide 0.2 mg/ml Oral Solution
How do I take Bumetanide 0.2 mg/ml Oral Solution?
Bumetanide 0.2 mg/ml Oral Solution comes as oral solution containing 0.2mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Bumetanide 0.2 mg/ml Oral Solution?
The active substance in Bumetanide 0.2 mg/ml Oral Solution is bumetanide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Bumetanide 0.2 mg/ml Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Bumetanide 0.2 mg/ml Oral Solution without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: bumetanide
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Bumetanide is indicated whenever diuretic therapy is required in the treatment of oedema, e.g. that associated with congestive heart failure, cirrhosis of the liver and renal disease including the nephrotic syndrome.
4.2. Posology and method of administration
Posology
Adults, adolescents and children aged 12 years and older
Usually 1 mg (5 ml) as a single oral dose given morning or early evening. The dosage should be adjusted according to the patient's response.
Elderly
Adjust dosage according to response: a dose of 0.5 mg bumetanide per day may be sufficient in some elderly patients.
Paediatric population (children under 12 years)
Bumetanide Liquid should not be used for children under 12 years of age.
Method of administration
For oral administration.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listen in section 6.1.
Although bumetanide can be used to induce diuresis in renal insufficiency, any marked increase in blood urea or the development of oliguria or anuria during treatment of severe progressing renal disease are indications for stopping treatment with bumetanide.
Bumetanide is contra-indicated in hepatic coma and care should be taken in states of severe electrolyte depletion.
4.4. 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. Electrolyte disturbances may occur, particularly in those patients taking a low salt diet. Regular checks of serum electrolytes, in particular sodium, potassium, chloride and bicarbonate should be performed, and replacement therapy instituted where indicated.
As with other diuretics, bumetanide may cause an increase in blood uric acid. Periodic checks on urine and blood glucose should be made in diabetics and patients suspected of latent diabetes (see section 4.5).
Patients with chronic renal failure on high doses of bumetanide should remain under constant hospital supervision.
Caution is advised when used in patients with hypotension and in patients with porphyria.
Caution should be exercised when used in patients with hepatic impairment as there may be increased risk of encephalopathy.
Bumetanide should be used with caution in patients already receiving nephrotoxic or ototoxic drugs.
In patients with known hypersensitivity to sulfonamides or thiazides there may be a potential risk of hypersensitivity to bumetanide.
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.
Bumetanide found in urine by doping test is cause for disqualification of athletes.
Excipients:
This medicine contains 1375 mg sorbitol in each spoonful (5 ml) which is equivalent to 275 mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reaction (possibly delayed).
This medicine contains less than 1 mmol sodium (23 mg) per spoonful (5 ml), that is to say essentially 'sodium-free'
4.5. Interaction with other medicinal products and other forms of interaction
In common with other diuretics, serum lithium levels may be increased when lithium is given concurrently with bumetanide.
This may result in increased lithium toxicity, including increased risk of cardiotoxic and neurotoxic effects of lithium. Therefore, it is recommended that lithium levels are carefully monitored and where necessary the lithium dosage is adjusted in patients receiving this combination.
Like other diuretics, bumetanide shows a tendency to increase the excretion of potassium which can lead to an increase in the sensitivity of the myocardium to the toxic effects of digitalis. Thus, the dose may need adjustment when given in conjunction with cardiac glycosides.
Bumetanide may potentiate the effects of antihypertensive drugs. Therefore, the dose of the latter may need adjustment when bumetanide is used to treat oedema in hypertensive patients.
Certain non-steroidal anti-inflammatory drugs have been shown to antagonise the action of diuretics.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of Bumetanide in pregnant women. Bumetanide should not be used during pregnancy unless clearly necessary. It may be used only when the potential benefit justifies the potential risk to the foetus.
Breast-feeding
There is insufficient information on the excretion of Bumetanide in human or animal breast milk. Therefore, Bumetanide should not be taken by nursing mothers.
4.7. Effects on ability to drive and use machines
Patients who experience dizziness or fatigue should not drive or operate machinery.
4.8. Undesirable effects
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).
The following side effects, listed below by system organ class, have been reported to be associated with bumetanide use. Since only post marketing data are available, the frequency for these side effects is unknown.
Blood and lymphatic system disorders
Thrombocytopenia, leukopenia, bone marrow failure, agranulocytosis
Immune system disorders
Hypersensitivity
Metabolism and nutrition disorders
Electrolyte imbalance, for example:
Hypokalaemia, hyponatraemia, dehydration, hypomagnesaemia, gout, hyperuricaemia, alkalosis hypochloraemic, hyperglycaemia, hypocalcaemia, hyperlipidaemia
Nervous system disorders
Headache, dizziness
Ear and labyrinth disorders
Tinnitus, deafness
Vascular disorders
Orthostatic hypotension, hypotension
Gastrointestinal disorders
Gastrointestinal disorder, for example:
Nausea, vomiting, diarrhoea, abdominal pain
Hepatobiliary system disorders
Cholestasis, jaundice
Skin and subcutaneous tissue disorders
Rash*, urticaria, dermatitis, photosensitivity reaction, pruritus, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).
*Various types of rash reactions such as erythematous, maculo-papular and pustular have been reported.
Musculoskeletal, connective tissue and bone disorders
Myalgia, muscle spasm, arthralgia
Renal and urinary disorders
Renal failure acute
Reproductive system and breast disorders
Gynaecomastia, breast pain
General disorders and administrative site conditions
Fatigue
Investigations
Blood creatinine increased
High 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 per day 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.
4.9. Overdose
Symptoms would be those caused by excessive diuresis. Empty stomach by gastric lavage or emesis. General measures should be taken to restore blood volume, maintain blood pressure and correct electrolyte disturbance.
💬 Ask about this leaflet
Ask anything about Bumetanide 0.2 mg/ml Oral Solution. 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.