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/Amiloride 1mg/5mg Tablets
⚠ 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 Amiloride hydrochloride, 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/Amiloride Tablets contain two different medicines. One medicine is called bumetanide and the other medicine is called amiloride hydrochloride. These both belong to a group of medicines called diuretics (water tablets). Bumetanide/Amiloride works by removing any excess water from your body. It will make you go to the toilet more. Bumetanide/Amiloride is used to treat oedema. Oedema means that there is too much water in your body. Oedema can cause symptoms such as swollen ankles or trouble breathing. 2.
What you need to know before you take it
e Bumetanide/Amiloride Tablets
Do not take Bumetanide/Amiloride Tablets: if you are allergic to bumetanide or amiloride hydrochloride, or any of the other ingredients of this medicine (listed in section 6). if you know that you have any sugar intolerance. You may have inherited this condition from someone else in your family. if you cannot pass water (urine) at all. if you have severe kidney problems or severe liver problems such as cirrhosis. if you know you have a condition called Addison's disease. if you have been told that you have high levels of potassium in your blood. if you have been told that you have low levels of certain salts in your blood. if you are taking potassium supplements or any medicines that may change the amount of potassium in your body. Ask your doctor if you are not sure. Warnings and precautions Talk to your doctor or pharmacist before taking Bumetanide/Amiloride Tablets: if you have diabetes if you have gout if you have prostate problems or have difficulty passing urine if you are vomiting or have diarrhoea if you have low blood pressure if you have a condition called porphyria
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If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Bumetanide/Amiloride Tablets or other sulphonamides, e.g., loop diuretics. if you have liver disease if you are allergic to medicines called sulfonamides or thiazides if you are an athlete who undergoes doping testing.
Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with Bumetanide/Amiloride Tablets treatment. Stop using Bumetanide/Amiloride Tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. When you are taking Bumetanide/Amiloride Tablets your doctor may take regular blood tests. This is very important in the elderly, in diabetics or in seriously ill patients. If you are going to have a "glucose tolerance test" tell the doctor or nurse you are taking Bumetanide/Amiloride Tablets as this may affect the results. 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). Other medicines and Bumetanide/Amiloride Tablets Tell your doctor or pharmacist if you are taking, or have recently taken, or might take any other medicines. This includes any medicines which you have bought without a prescription. Do not take Bumetanide/Amiloride if you are taking potassium supplements or any medicines that may change the amount of potassium in your body. You must tell your doctor or pharmacist if you are taking any of the following medicines: medicines for heart conditions, such as digoxin, ACE inhibitors, angiotensin II receptor antagonists. Your doctor may need to change your dose medicines for high blood pressure. This includes alpha-blockers such as prazosin or indoramin which can also be used for prostate problems in men non-steroidal anti-inflammatory drugs, such as ibuprofen, for arthritis or aches or pains 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 any medicines that make you feel dizzy on standing up e.g. tricyclic antidepressants such as amitriptyline medicines for diabetes. Your doctor may need to change your dose any medicines that may affect your kidneys cephalosporin antibiotics aminoglycoside antibiotics (e.g. gentamicin) or other medicines which may affect your hearing tetracycline antibiotics (e.g. oxytetracycline) probenecid, a medicine used in special cases, to protect the kidneys ciclosporin, a medicine used to suppress the immune system trilostane, a medicine used to stop excessive production of steroids, or in women with breast cancer. Pregnancy and breast-feeding 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 any medicine. Driving and using machines This medicine may cause dizziness, drowsiness, tiredness or feeling faint as side effects. You must not drive or use machines if you get any of these side effects. Bumetanide/Amiloride Tablets contain lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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3.
How to take it
Bumetanide/Amiloride Tablets
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Dosages Your doctor will tell you how many tablets to take. You are likely to need the toilet more often after you have taken your tablets. Remember that this may be inconvenient if you are going on a long journey or want to go to sleep. Remember to always take this medicine with at least half a glass of water. Take your tablets at the same time each day. This makes it easier to remember them. Adults and the elderly The recommended dose is one or two tablets each day. Your doctor may change your dose depending on your test results. If you forget how many tablets to take, look at the label on your pack. If you are still not sure, ask your doctor or pharmacist. Use in children and adolescents This medicine is not suitable for children or adolescents (under the age of 18 years). Method of administration The score line is not intended for breaking the tablet. If you take more Bumetanide/Amiloride Tablets than you should Tell your doctor straight away. You may need to stop taking this medicine. If you forget to take Bumetanide/Amiloride Tablets If you forget to take your medicine, and you are less than 12 hours late, you can still take it. If you are more than 12 hours late taking your medicine then leave out this dose. Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you have any further questions about taking this medicine, please ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP using Bumetanide/Amiloride Tablets and seek medical attention immediately if you notice any of the following symptoms: 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]. You must get medical help straight away if you have any of the following symptoms. You may be having a severe allergic reaction: difficulty breathing or swallowing, swelling of the face, lips, tongue or throat severe itching of the skin, with a red rash or raised lumps Seek immediate medical attention if you have any of the following symptoms: –
you feel shaky, faint or your heart starts to beat fast or irregularly. This may be due to a shocklike reaction
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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 you have liver problems and you feel confused, forgetful or faint, or if your skin or eyes become yellow, or if you have pale faeces, dark urine or itchy skin unusual or increased bleeding or bruising fever, sore throat, mouth ulcers, repeated infections that keep coming back feeling tired, breathless, looking pale.
Tell your doctor if you get any of the following side effects: Digestive problems: feeling or being sick indigestion, heartburn stomach pain or cramps, wind diarrhoea, constipation. Skin problems: rash, including dermatitis itching skin itchy raised skin (hives) reactions to the sun. Your skin may become red, painful and swollen – do not sunbathe, use a sunbed, or expose your skin to UV light. Other problems: noticing your heart beats which may be slower or faster than usual chest pain (angina) swollen or painful breasts (sometimes in men) erectile problems, decreased sexual drive muscle cramps or pain 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) tingling or numbness sensation headache confusion ringing or buzzing in the ears (tinnitus), deafness you feel unusually thirsty with dry skin, dark urine, dry mouth, headache. This may be due to dehydration you feel dizzy or have 'head spins' light-headedness or dizziness when standing up from a sitting or lying position a collection of symptoms including thirst, frequent urination, tiredness, and increased susceptibility to infection, such as thrush. This may be due to too much glucose in the body. Your doctor can test for this you feel drowsy or tired. 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Bumetanide/Amiloride Tablets
Keep out of the sight and reach of children. Do not use the tablets after the expiry which is stated on the carton after EXP. The expiry date refers to the last day of that month.
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Do not throw away any medicines via household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6.
Contents of the pack and other information
What Bumetanide/Amiloride Tablets contains The active substances are bumetanide and amiloride hydrochloride. Each tablet contains 1 mg bumetanide and 5 mg amiloride hydrochloride. The other ingredients are lactose, magnesium stearate, maize starch and microcrystalline cellulose (see end of section 2 for further information on lactose). What Bumetanide/Amiloride Tablets look like and contents of the pack Bumetanide/Amiloride Tablets are cream oval tablets, with a break line on one side and marked '149' on the reverse. They are available in blister packs of 14, 28, 56 tablets, and bottles of 50 and 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Chemidex Pharma Ltd, trading as Essential Generics, 8a Crabtree Road, Egham, Surrey TW20 8RN. Manufacturer Lelypharma B.V., Zuiveringweg 42, 8243 PZ Lelystad, the Netherlands. Dales Pharmaceuticals Ltd, Snaygill Industrial Estate, Keighley Road, Skipton BD23 2RW. This leaflet was last revised in 09/2024
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Frequently asked questions about Bumetanide/Amiloride 1mg/5mg Tablets
How do I take Bumetanide/Amiloride 1mg/5mg Tablets?
Bumetanide/Amiloride 1mg/5mg Tablets comes as tablet containing 1mg / 5mg. 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/Amiloride 1mg/5mg Tablets?
The active substance in Bumetanide/Amiloride 1mg/5mg Tablets is amiloride hydrochloride, bumetanide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Bumetanide/Amiloride 1mg/5mg Tablets, 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/Amiloride 1mg/5mg Tablets 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: amiloride hydrochloride, 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/Amiloride 1mg/5mg Tablets are indicated where a prompt diuresis is required. It is particularly of value in conditions where potassium conservation is important.
4.2. Posology and method of administration
Posology
Adults
The normal adult dose is 1 to 2 tablets daily. The dose may be adjusted according to response.
Elderly
The dose should be adjusted according to needs and serum electrolytes and urea should be monitored carefully.
Paediatric population
Bumetanide/Amiloride 1mg/5mg Tablets should not be used in children and adolescents under the age of 18 years.
Method of administration
For oral administration.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Hyperkalaemia (serum potassium >5.3 mmol/litre), severe electrolyte imbalance, acute renal insufficiency, severe progressive renal disease, anuria, severe liver disease, adrenocortical insufficiency (Addison's Disease), precomatose states associated with cirrhosis, known sensitivity to bumetanide or amiloride or to Bumetanide/Amiloride 1mg/5mg Tablets. Bumetanide/Amiloride 1mg/5mg Tablets should not be given concurrently with potassium supplements or potassium-sparing agents.
Bumetanide/Amiloride 1mg/5mg Tablets are contra-indicated in children as safety in this age group has not been established.
Bumetanide/Amiloride 1mg/5mg Tablets are contra-indicated in hepatic coma and care should be taken in states of severe electrolyte depletion.
4.4. Special warnings and precautions for use
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.
Serum uric acid levels may be increased and acute attacks of gout may be precipitated. Patients with prostatic hypertrophy or impaired micturition may be at risk of developing acute retention.
To minimise risk of hyperkalaemia, caution is advised if bumetanide/amiloride tablets are administered to patients with known/suspected diabetes mellitus (see section 4.5).
Bumetanide/Amiloride 1mg/5mg Tablets should be discontinued before a glucose tolerance test. The tablets may cause latent diabetes to become manifest. It may be necessary to increase the dose of hypoglycaemic agents in diabetic patients.
Bumetanide/Amiloride 1mg/5mg Tablets should be used with caution in patients already receiving nephrotoxic or ototoxic drugs.
Patients who are being treated with this preparation require regular supervision with monitoring of fluid and electrolyte status to avoid excessive fluid loss.
In common with other potent diuretics, Bumetanide/Amiloride 1mg/5mg Tablets should be used with caution in elderly patients or those with disorders rendering electrolyte balance precarious.
Hyponatraemia, hypochloraemia and raised blood urea may occur during vigorous diuresis especially in seriously ill patients. Careful monitoring of serum electrolytes and urea should be undertaken in these patients.
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.
In patients with known hypersensitivity to sulfonamides or thiazides there may be a potential risk of hypersensitivity to bumetanide.
Bumetanide and/or amiloride found in urine by doping test is cause for disqualification of athletes.
Excipients
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.
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.
Hyperkalaemia has been observed in patients receiving amiloride and therefore concurrent use of Bumetanide/Amiloride 1mg/5mg Tablets with potassium conserving diuretics is not recommended.
As ACE Inhibitors, angiotensin II receptor antagonists, ciclosporin and trilostane may elevate serum potassium levels, especially in the presence of renal impairment, combination with
Bumetanide/Amiloride 1mg/5mg Tablets is best avoided in elderly patients or in those in whom renal function may be compromised. If use of the combination is considered essential the clinical condition and serum electrolytes must be carefully and continuously monitored.
Bumetanide can cause hypokalaemia, which can increase the sensitivity to digitalis glycosides and non-depolarising neuromuscular blocking agents.
The dose of cardiac glycosides or hypotensive agents may require adjustment.
Bumetanide/Amiloride may potentiate the effect of antihypertensive agents including diuretics and drugs inducing postural hypotension e.g. tricyclic antidepressants. Therefore the dose of these drugs may need adjustment when bumetanide/amiloride tablets are used to treat oedema in hypertensive patients. Certain non-steroidal anti-inflammatory drugs have been shown to antagonise the action of diuretics, increase the risk of nephrotoxicity and increase the risk of hyperkalaemia.
The toxic effects of nephrotoxic drugs may be increased by concomitant administration of potent diuretics such as bumetanide.
Impairment of renal function may develop in patients receiving treatment with bumetanide and high doses of certain cephalosporins.
Concurrent use of tetracyclines and diuretics should be avoided because of their association with rises in blood urea nitrogen levels.
Bumetanide may potentiate the ototoxicity of aminoglycosides and other ototoxic drugs. Since this may lead to irreversible damage, these drugs must not be used with Bumetanide/Amiloride unless there are compelling medical reasons. In such situations, careful medical supervision is required.
As would be expected, the use of an alpha blocker with a diuretic may result in an additive hypotensive effect, but aside from first-dose hypotension, this usually seems to be a beneficial interaction in patients with hypertension. The effects in patients with congestive heart failure may be more severe.
Bumetanide/Amiloride may antagonise hypoglycaemic effect of antidiabetic drugs. Adjustment of the dose of antidiabetic drugs may be needed in concomitant use (see section 4.4).
Probenecid, when administered concomitantly with bumetanide, may lead to diminished natriuresis. Increased natriuresis may be observed when administered concomitantly with amiloride. The effect on natriuresis may therefore be cancelled out when co-administering probenecid and Bumetanide/Amiloride.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of Bumetanide/Amiloride in pregnant women.
Bumetanide/Amiloride 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/Amiloride in human or animal breast milk. Therefore Bumetanide/Amiloride should not be taken by nursing mothers.
Fertility
No specific data.
4.7. Effects on ability to drive and use machines
Bumetanide/Amiloride 1mg/5mg Tablets have moderate influence on the ability to drive and use machines. Patients who experience dizziness or fatigue should not drive or operate machinery.
4.8. Undesirable effects
The following side effects, listed below by system organ class, have been reported to be associated with bumetanide or amiloride use, which should be considered as potential adverse effects of Bumetanide/Amiloride 1mg/5mg Tablets. Since only post marketing data are available, the frequency for these side effects is unknown.
Bumetanide-related effects
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
*Various types of rash reactions such as erythematous, maculo-papular and pustular have been reported
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).
Frequency not known: Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)
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.
Amiloride-related effects
Metabolism and nutrition disorders
Hyperkalaemia, hyperuricaemia, hyponatraemia
Psychiatric Disorders
Psychiatric symptoms, for example:
Confusion, libido decreased
Nervous system disorders
Headache, dizziness, paraesthesia, encephalopathy
Ear and labyrinth disorders
Tinnitus, vertigo
Cardiac disorders
Arrhythmia, atrioventricular block complete (one patient with partial heart block developed complete heart block), angina pectoris, palpitations
Vascular disorders
Orthostatic hypotension
Gastrointestinal disorders
Gastrointestinal disorder, for example:
Nausea, abdominal pain, diarrhoea, constipation, vomiting, dyspepsia, flatulence
Hepatobiliary system disorders
Jaundice
Skin and subcutaneous tissue disorders
Rash, pruritus
Musculoskeletal, connective tissue and bone disorders
Muscle spasm
Reproductive system disorders
Impotence
General disorders and administrative site conditions
Thirst
Investigations
Hepatic enzyme abnormal
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 www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Symptoms would be those caused by excessive diuresis such as dehydration, electrolyte imbalance, particularly hyperkalaemia, and hypotension and treatment should be aimed at reversing these.
Management
No specific antidote is available. Treatment is symptomatic and supportive. If hyperkalaemia is present appropriate measures must be instituted to reduce serum potassium.
💬 Ask about this leaflet
Ask anything about Bumetanide/Amiloride 1mg/5mg 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.