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 Amiloride hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for The name of your medicine is Amiloride 5mg Tablets. It contains amiloride hydrochloride. This belongs to a group of medicines called diuretics (water tablets). Amiloride can be used to stop the build up of extra water in your body. It does this without loss of potassium from your body. This extra water can lead to high blood pressure, heart problems (congestive heart failure) and liver problems (hepatic cirrhosis). It works by helping you to pass more water (urine) than you usually do.
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2. Before you take Amiloride Tablets Do not take Amiloride Tablets and tell your doctor if:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amiloride Tablets. Tests Tell your doctor or nurse you are taking Amiloride Tablets if you are going to have a glucose tolerance test. This is because this medicine can affect the results. You will need to stop taking this medicine three days before your test. Taking other medicines Please tell your doctor of pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Amiloride Tablets can affect the way some other medicines work. Also, some medicines can affect the way Amiloride Tablets work. In particular, tell your doctor if you are taking any of the following:
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PRODUCT : CUSTOMER : FP CODE: PLANT LOCATION : DIMENSIONS : PHARMACODE : SAP CODE No. : TEXT FONT SIZE : FILE NAME : SOFTWARE : TYPEFACES : ARTWORK (DETAILS) RECEIVED ON : PROOF REVISION :
Amiloride HCL 5mg – 28 Tablets Wockhardt UK FP1936 Daman (Bhimpore) (w)148 x (h)275mm 2824 227617 (PREVIOUS VERSION SAP CODE No. : 225708) 9pt. Amiloride_Lit_108299-2.ai Adobe Illustrator CS6 Myriad Pro Regular / Bold 22nd & 29th December, 2022 R 1st PDF sent on – 2ND JAN. 2023 R 2ndPDF sent on – 6TH JAN. 2023
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • Removed MT details to create UK specific artwork
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6. Further information What Amiloride Tablets contains
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Like all medicines, Amiloride Tablets can cause side effects although not everybody gets them. If you have an allergic reaction to Amiloride Tablets see a doctor straight away An allergic reaction may include:
Amiloride Tablets Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure. Taking this medicine
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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 App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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Amiloride Tablets
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4. Possible side effects
Amiloride 5mg 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 Amiloride 5mg Tablets is amiloride hydrochloride.
This leaflet reproduces the patient information leaflet approved for Amiloride 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.
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.
Amiloride is a diuretic used alone or as an adjunct to other diuretics in the treatment of oedema and hypertension.
Adults:
Initially 10mg daily or 5mg twice daily, adjusted according to response. The dosage may be increased up to a maximum of 20mg daily. Used as an adjunct to other diuretics for hypertension and congestive heart failure: Initially 5mg or 10mg daily. Cirrhosis with ascites: Initially 5mg daily. Elderly:
The dosage should be adjusted according to renal function, blood electrolytes and diuretic response. Children under 18 years : Not indicated.
Hyperkalaemia, severe renal impairment, prior sensitivity to amiloride. Other potassium-sparing drugs and potassium supplements are contraindicated during amiloride therapy. The safety of amiloride hydrochloride for use in children under 18 years of age has not been established.
Amiloride should be given with caution to elderly patients, patients likely to develop acidosis, patients with diabetes mellitus and those with impaired hepatic or renal function. Patients with impaired renal function should be monitored carefully for serum electrolytes and blood urea levels, as should seriously ill patients, such as those with hepatic cirrhosis with ascites and metabolic alkalosis or those with resistant oedema who are also taking diuretics. Patients taking amiloride either alone or with other diuretics or angiotensin-converting enzyme inhibitors may develop hyperkalaemia. Serum electrolytes and blood urea should be monitored periodically. If hyperkalaemia occurs, amiloride hydrochloride should be discontinued immediately and, if necessary, active measures taken to reduce the plasma potassium level. Amiloride should be discontinued at least three days before a glucose tolerance test because of the risk of provoking severe hyperkalaemia. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Alcohol: Postural hypotension associated with diuretic therapy may be enhanced. Aldesleukin: Enhanced hypotensive effect may occur when aldesleukin and amiloride are used concomitantly. Anaesthetics, general: Enhanced hypotensive effect may occur when general anaesthetics and amiloride are used concomitantly.Analgesics: Diuretics increase the risk of nephrotoxicity with NSAIDs. Indometacin and possibly other NSAIDs increase the risk of hyperkalaemia with potassium-sparing diuretics. Indometacin and ketorolac antagonise the diuretic effect. Antiarrhythmics: The antiarrhythmic activity of quinidine can be opposed by amiloride.Antidepressants: increased risk of postural hypotension with tricyclics. Enhanced hypotensive effect with monoamine oxidase inhibitors (MAOIs).Antidiabetic agents: Chlorpropamide increases the risk of hyponatraemia associated with thiazides in combination with potassium sparing diuretics. Antiepileptics: increased risk of hyponatraemia with carbamazepine.Antihypertensives: An enhanced hypotensive effect (which can be extreme) can occur with antihypertensives, including ACE inhibitors, angiotensin-II antagonists, calcium channel blockers, beta blockers, alpha blockers (increased risk of first dose hypotension) or hydralazine. With ACE inhibitors and angiotensin-II antagonists there is also an increased risk of hyperkalaemia.Antipsychotics: Lithium should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Enhanced hypotensive effect may occur when phenothiazines and amiloride are used concomitantly.Corticosteroids: Fluid retention associated with corticosteroid use may antagonise the diuretic/antihypertensive response.Dopaminergics: Enhanced hypotensive effect may occur when levodopa and amiloride are used concomitantly.Hormones and other endocrine drugs: Combined oral contraceptives and oestrogens may antagonise the diuretic effect. There is an increased risk of hyperkalaemia with trilostane.Immunosuppressants: increased risk of hyperkalaemia with ciclosporin and tacrolimus. Increased risk of nephrotoxicity with concomitant use of ciclosporin and amiloride.Muscle relaxants: enhanced hypotensive effect with baclofen and tizanidine.Nitrates: Enhanced hypotensive effect may occur when nitrates and amiloride are used concomitantly.Potassium conserving agents, potassium supplements: When amiloride is administered concomitantly with potassium conserving agents or potassium supplements, there is an increased risk of hyperkalaemia (see 4.3 Contraindications).Prostaglandins: Hypotensive effect may be potentiated by alprostadil.Ulcer-healing agents: Amiloride antagonises the ulcer-healing effect of carbenoxolone.Laboratory value alterations: Creatinine clearance: Amiloride blocks the tubular secretion of creatinine, leading to falsely high measurements of creatinine clearance.
Amiloride is not recommended for use during pregnancy or lactation. The potential benefits of the drug must be weighed against possible hazards to the foetus if it is administered to a woman of child bearing age.
Reduced mental alertness may impair ability to drive or operate dangerous machinery.
Amiloride is usually well tolerated. Except for hyperkalaemia significant side effects are infrequent. Reported side-effects include the following:Blood and lymphatic system disorders: Aplastic anaemia and neutropenia have been reported rarely.Psychiatric disorders: Decreased libido, somnolence, mental confusion, or minor psychiatric changes may occur.Nervous system disorders: Encephalopathy, paraesthesia. Eye disorders: Visual changes. Cardiac disorders: Angina pectoris, arrhythmias, palpitations, postural hypotension, dizziness.Respiratory, thoracic and mediastinal disorders: Dyspnoea, cough.Gastrointestinal disorders: Nausea, vomiting, constipation or diarrhoea, abdominal pain. Hepatobiliary disorders: Abnormal liver function. A deepening of jaundice has occurred in cirrhotic patients receiving amiloride hydrochloride alone, but the relationship to amiloride is uncertain.Skin and subcutaneous tissue disorders: Alopecia, rash, pruritus.Renal and urinary disorders: Effects on electrolyte balance e.g. hyperkalaemia (particularly in elderly patients, diabetics and patients with renal impairment) and hyponatraemia occasionally occur. Signs include dry mouth, thirst, headache, muscle cramps and weakness. Rises in blood-urea-nitrogen concentrations may occur with amiloride.Reproductive and breast disorders: Impotence. 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.
Symptoms
The most likely signs and symptoms are dehydration and electrolyte imbalance which should be treated by established methods. Amiloride should be discontinued and the patient observed closely. Treatment
No specific antidote is available. Patients who present within one hour of overdose may be administered activated charcoal. Treatment should be symptomatic and supportive. If hyperkalaemia occurs, active measures should be taken to reduce plasma potassium levels.
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Amiloride hydrochloride. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Amiloride 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.
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