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.
Spironolactone 12.5 mg Film-coated 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 Spironolactone 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 The active ingredient of the tablets is spironolactone. Spironolactone belongs to a group of medicines called 'diuretics' – you may know these as 'water' tablets. You may have gone to your doctor because you had swollen ankles or were short of breath. This can happen when your heart's pumping action has become weak because of too much fluid in your body. This is called "congestive heart failure". Pushing extra fluid around your body means your heart has to work harder. Your doctor has given you to help you lose the extra fluid from your body. This will mean your heart has to do less work. You lose the extra fluid as urine, so you may need to go to the toilet more often while you are taking spironolactone. You can take spironolactone for the following illnesses:
"Nephrotic syndrome" – a kidney disorder that causes too much fluid in your body "Ascites" – too much fluid in your abdomen and "oedema" – accumulation of fluid beneath skin or in one or more cavities of the body that produces swelling, for example caused by cirrhosis of the liver "Malignant ascites" – fluid containing cancer cells that collect in the abdomen "Primary aldosteronism" – extra fluid in your body caused by too much of a hormone called "aldosterone".
Version No.: 03 (September2020)
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Package Leaflet Spironolactone 12.5 mg Film-coated Tablets Spironolactone 25 mg Film-coated Tablets Spironolactone 50 mg Film-coated Tablets Spironolactone 100 mg Film-coated Tablets
Mercury Pharmaceuticals Limited PL 12762/0544 PL 12762/0545 PL 12762/0546 PL 12762/0547
Children should only be treated under guidance of a paediatric specialist. If you have these illnesses, spironolactone tablets will help your body to get rid of the extra fluid. You must talk to a doctor if you do not feel better or if you feel worse. Children should only be treated under guidance of a paediatric specialist.
What you need to know before you take it
e Spironolactone Tablets Do not take Spironolactone Tablets if you are allergic to spironolactone or any of the other ingredients of this medicine (listed in section 6) if you cannot pass urine if you have severe kidney disease if you have Addison's disease; (a hormone deficiency characterised by extreme weakness, loss of weight and low blood pressure) if you have hyperkalaemia (raised blood potassium levels) if you are breast-feeding if you are taking water tablets (potassium sparing diuretics) or any potassium supplements if you are taking eplerenone (a medicine for high blood pressure) Children with moderate to severe kidney disease must not take spironolactone. Warnings and precautions Talk to your doctor or pharmacist before taking Spironolactone tablets
if you suffer from kidney disease especially children with hypertension or liver disease. if you are elderly. Your doctor will routinely assess you if you have difficulty passing urine if you have a disease that can result in electrolyte balance disturbance in your blood such as potassium or sodium if you have severe heart failure if you are pregnant
If you experience reduced kidney function or kidney failure you may have severe increases in the levels of potassium in your blood. This can affect the way your heart functions and in extreme cases this can be fatal. Concomitant administration of spironolactone with certain medicines, potassium supplements and food rich in potassium may lead to severe hyperkalaemia (increased potassium blood level). The symptoms of severe hyperkalaemia might include muscle cramps, irregular heart rhythm, diarrhoea, nausea, dizziness or headache. Other medicines and spironolactone tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, your doctor may wish to alter your dose of spironolactone tablets if you are taking any of the following:
digoxin or carbenoxolone medicines for high blood pressure including angiotensin-converting enzyme (ACE) inhibitors other diuretics non-steroidal anti-inflammatory drugs (NSAID) such as aspirin, indomethacin, mefenamic acid or ibuprofen potassium supplements heparin or low molecular weight heparin (medicines used to prevent blood clots)
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Package Leaflet Spironolactone 12.5 mg Film-coated Tablets Spironolactone 25 mg Film-coated Tablets Spironolactone 50 mg Film-coated Tablets Spironolactone 100 mg Film-coated Tablets
Mercury Pharmaceuticals Limited PL 12762/0544 PL 12762/0545 PL 12762/0546 PL 12762/0547
antipyrine medicines known to cause hyperkalaemia (raised blood potassium levels) trimethoprim and trimethoprim-sulfamethoxazole
Tell your doctor, if you are using abiraterone for treatment of prostate cancer Tell your doctor, if you are using mitotane for treatment of malignant tumours of the adrenal glands. This medicine should not be used together with mitotane. Spironolactone reduces your responsiveness to noradrenaline. If you are going to have an operation where you will be given an anaesthetic, tell the doctor in charge that you are taking spironolactone. Spironolactone tablets with food, drink and alcohol See section 3 "How to take spironolactone tablets" Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Spironolactone tablets should not be used if you are breast-feeding. You should discuss the use of spironolactone with your doctor, who will advise you to consider an alternative method of feeding your baby while you are taking this medicine. Driving and using machines Take care if you drive or operate machinery. Drowsiness and dizziness have been associated with spironolactone tablets treatment and this may affect your ability to drive or operate machinery safely. Spironolactone tablets contain lactose This medicine contains 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.
How to take it
spironolactone tablets Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The pharmacist's label on the pack also gives this information. The number of tablets you need to take depends on your illness. Recommended dose This medicine should be taken once a day with food. Adults The adult dose varies from 25mg to 400mg spironolactone a day, depending on the condition being treated. If you are not sure how much to take, ask your doctor or pharmacist. Elderly Your doctor will start you on a low starting dose and gradually increase the dosage as needed to obtain the desired effect. Use in children and adolescents If you are giving spironolactone tablets to a child, the number of tablets you give will depend on the child's weight. Your doctor will work out the number of tablets that you should give. If you take more spironolactone tablets than you should Version No.: 03 (September2020)
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Package Leaflet Spironolactone 12.5 mg Film-coated Tablets Spironolactone 25 mg Film-coated Tablets Spironolactone 50 mg Film-coated Tablets Spironolactone 100 mg Film-coated Tablets
Mercury Pharmaceuticals Limited PL 12762/0544 PL 12762/0545 PL 12762/0546 PL 12762/0547
If you accidentally take too many tablets, contact your doctor or nearest hospital accident and emergency department immediately. The symptoms of an overdose are feeling drowsy, dizzy, feeling dehydrated and you may feel confused. You may also feel or be sick, suffer from diarrhoea and may have skin rashes that will appear as flat red areas of skin with overlapping small raised bumps. Changes in your blood sodium and potassium levels may leave you feeling weak and suffering from tingling, prickling or numbness of the skin and/or muscle spasms but these symptoms are unlikely to be associated with severe overdosage. If you forget to take spironolactone tablets If you forget to take your tablet, take it 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 stop taking spironolactone tablets It is important to keep taking spironolactone tablets until your doctor tells you to stop, even if you start to feel better. If you stop taking the tablets too soon, your condition may get worse. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, the symptoms can be severe. Itchiness and blistering of the skin around the lips and the rest of the body (Stevens-Johnson syndrome) Detachment of the top layer of skin from the lower layers of skin, all over the body (toxic epidermal necrolysis) Skin rash, fever and swelling (which could be symptoms of something more serious, drug rash and eosinophilia and systemic symptoms) Yellow skin and eyes (jaundice), spironolactone tablets can cause impairment of liver function Irregular heartbeat which can be fatal, tingling sensation, paralysis (loss of muscle function) or difficulty in breathing; which may be symptoms of raised potassium levels in your blood. Your doctor will conduct regular blood tests to monitor potassium and other electrolyte levels. They may stop your treatment if necessary. Other side effects of spironolactone tablets by frequency: Very common: may affect more than 1 in 10 people
raised potassium in the blood (hyperkalaemia)
Common: may affect up to 1 in 10 people
confusion, dizziness nausea muscle or leg cramps sudden kidney failure excessive growth of breast tissue in men (gynaecomastia, this goes away when treatment is stopped), breast lumps, breast pain general weakness
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Package Leaflet Spironolactone 12.5 mg Film-coated Tablets Spironolactone 25 mg Film-coated Tablets Spironolactone 50 mg Film-coated Tablets Spironolactone 100 mg Film-coated Tablets
Mercury Pharmaceuticals Limited PL 12762/0544 PL 12762/0545 PL 12762/0546 PL 12762/0547
skin rash, generalised itchiness
Uncommon: may affect up to 1 in 100 people
disturbances in body electrolytes abnormal liver function skin allergy with development of itchiness and weals (urticaria) menstrual problems in women, breast pain
Not known: frequency cannot be estimated from the available data
stomach upset change in sex drive for both men and women (libido) reduced number of cells that fight infection – white cells (leukopenia), reduced number of cells that help with clotting (thrombocytopenia) excessive hair growth (hypertrichosis), skin condition presenting with fluid – filled blisters (pemphigoid) hair loss
Reporting side-effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effect not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: 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.
How to store it
spironolactone tablets
Keep out of sight and reach of children. This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light. Do not use this medicine after the expiry date which is stated on the carton or blister label after "EXP". The expiry date refers to the last day of that month. 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 spironolactone tablets contain: The active substance is spironolactone. Each spironolactone 12.5 mg film-coated tablet contains 12.5 mg of spironolactone. Each spironolactone 25 mg film-coated tablet contains 25 mg of spironolactone. Each spironolactone 50 mg film-coated tablet contains 50 mg of spironolactone. Each spironolactone 100 mg film-coated tablet contains 100 mg of spironolactone. The other ingredients are lactose monohydrate, calcium sulphate dihydrate, crospovidone, povidone, maize starch, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. What spironolactone tablets look like and contents of the pack Spironolactone 12.5 mg film-coated tablets are white to off-white, round, biconvex tablets debossed on one side with "S1", approximately 5.75 mm in diameter Spironolactone 25 mg film-coated tablets are white to off-white, round, biconvex tablets debossed on one side with "S2", approximately 7.5 mm in diameter Version No.: 03 (September2020)
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Package Leaflet Spironolactone 12.5 mg Film-coated Tablets Spironolactone 25 mg Film-coated Tablets Spironolactone 50 mg Film-coated Tablets Spironolactone 100 mg Film-coated Tablets
Mercury Pharmaceuticals Limited PL 12762/0544 PL 12762/0545 PL 12762/0546 PL 12762/0547
Spironolactone 50 mg film-coated tablets are white to off-white, round, biconvex tablets debossed on one side with "S3", approximately 9 mm in diameter Spironolactone 100 mg film-coated tablets are white to off-white, round, biconvex tablets debossed on one side with "S4", approximately 12 mm in diameter Spironolactone 12.5 mg film-coated tablets come in PVC/foil blister packs containing 100 or 500 tablets and PVC/foil of 28 tablets. Spironolactone 25 mg film-coated tablets come in PVC/foil blister packs containing 100 or 500 tablets and PVC/foil of 28 tablets. Spironolactone 50 mg film-coated tablets come in PVC/foil blister packs containing 100 or 500 tablets and PVC/foil of 28 tablets. Spironolactone 100 mg film-coated tablets come in PVC/foil blister packs containing 100 or 500 tablets and PVC/foil of 28 tablets. Not all packs may be marketed. Marketing Authorisation Holder Mercury Pharmaceuticals Limited Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom Manufacturer: Key Pharmaceuticals Ltd. Galen House, 83 High Street, Somersham, Cambridgeshire, PE28 3JB, UK. This leaflet was last revised in April 2025.
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Frequently asked questions about Spironolactone 12.5 mg Film-coated Tablets
How do I take Spironolactone 12.5 mg Film-coated Tablets?
Spironolactone 12.5 mg Film-coated Tablets comes as tablet containing 12.5mg. 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 Spironolactone 12.5 mg Film-coated Tablets?
The active substance in Spironolactone 12.5 mg Film-coated Tablets is spironolactone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Spironolactone 12.5 mg Film-coated 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 Spironolactone 12.5 mg Film-coated 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: spironolactone
- 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
• Congestive cardiac failure
• Hepatic cirrhosis with ascites and oedema
• Malignant ascites
• Nephrotic syndrome
• Diagnosis and treatment of primary aldosteronism.
Children should only be treated under guidance of a paediatric specialist. There is limited paediatric data available (see sections 5.1 and 5.2)
4.2. Posology and method of administration
Posology
Adults
Congestive cardiac failure with oedema
For management of oedema an initial daily dose of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 mg to 200 mg daily. Maintenance dose should be individually determined.
Severe heart failure (New York Heart Association Class III-IV)
Based on the Randomised Aldactone Evaluation Study (RALES: see also section 5.1), treatment in conjunction with standard therapy should be initiated at a dose of spironolactone 25 mg once daily if serum potassium is ≤5.0 mEq/L and serum creatinine is ≤2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dose increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once daily may have their dose reduced to 25 mg every other day. See section 4.4 for advice on monitoring serum potassium and serum creatinine.
Hepatic cirrhosis with ascites and oedema
If urinary Na+/K+ ratio is greater than 1.0, 100 mg/day. If the ratio is less than 1.0, 200 mg/day to 400 mg/day. Maintenance dosage should be individually determined.
Malignant ascites
Initial dose usually 100 mg/day to 200 mg/day. In severe cases the dosage may be gradually increased up to 400 mg/day. When oedema is controlled, maintenance dosage should be individually determined.
Nephrotic syndrome
Usual dose 100 mg/day to 200 mg/day. Spironolactone has not been shown to be anti-inflammatory, or to affect the basic pathological process. Its use is only advised if glucocorticoids by themselves are insufficiently effective.
Diagnosis and treatment of primary aldosteronism
Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.
Long test: spironolactone is administered at a daily dosage of 400 mg for 3 to 4 weeks. Correction of hypokalaemia and hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.
Short test: spironolactone is administered at a daily dosage of 400 mg for 4 days. If serum potassium increases during spironolactone administration but drops when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.
After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered at doses of 100 mg to 400 mg daily in preparation for surgery.
For patients who are considered unsuitable for surgery, spironolactone may be employed for long- term maintenance therapy at the lowest effective dosage determined for the individual patient.
Elderly
It is recommended that treatment is started with the lowest dose and titrated upwards as required to achieve maximum benefit. Care should be taken with severe hepatic and renal impairment which may alter drug metabolism and excretion.
Paediatric population
Initial daily dosage should provide 1-3 mg of spironolactone per kilogram body weight given in divided doses. Dosage should be adjusted on the basis of response and tolerance (see sections 4.3 and 4.4).
Children should only be treated under guidance of a paediatric specialist. There is limited paediatric data available (see sections 5.1 and 5.2).
Method of administration
Administration of spironolactone tablets once daily with a meal is recommended.
4.3. Contraindications
Spironolactone is contraindicated in adult and paediatric patients with the following:
• acute renal insufficiency, significant renal compromise, anuria
• Addison's disease
• hyperkalaemia
• hypersensitivity to spironolactone or to any of the excipients listed in section 6.1
• concomitant use of eplerenone or other potassium sparing diuretics.
Spironolactone is contraindicated in paediatric patients with moderate to severe renal impairment.
Spironolactone should not be administered concurrently with other potassium conserving diuretics and potassium supplements should not be given routinely with spironolactone as hyperkalaemia may be induced.
4.4. Special warnings and precautions for use
Fluid and electrolyte balance
Fluid and electrolyte status should be regularly monitored particularly in the elderly, in those with significant renal and hepatic impairment.
Hyperkalaemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities which may be fatal. Should hyperkalaemia develop spironolactone should be discontinued, and if necessary, active measures taken to reduce the serum potassium to normal (see section 4.3).
Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia has been reported to occur in some patients with decompensated hepatic cirrhosis, even in the presence of normal renal function.
Concomitant use of spironolactone with other potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs, angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin or other drugs or conditions known to cause hyperkalaemia, potassium supplements, a diet rich in potassium or salt substitutes containing potassium, may lead to severe hyperkalaemia.
Urea
Reversible increases in blood urea have been reported in association with spironolactone therapy, particularly in the presence of impaired renal function.
Hyperkalaemia in Patients with Severe Heart Failure
Hyperkalaemia may be fatal. It is critical to monitor and manage serum potassium in patients with severe heart failure receiving spironolactone. Avoid using other potassium-sparing diuretics. Avoid using oral potassium supplements in patients with serum potassium >3.5 mEq/L. The recommended monitoring for potassium and creatinine is 1 week after initiation or increase in dose of spironolactone, monthly for the first 3 months, then quarterly for a year, and then every 6 months. Discontinue or interrupt treatment for serum potassium >5 mEq/L or for serum creatinine >4 mg/dL (see section 4.2).
Paediatric population
Potassium-sparing diuretics should be used with caution in hypertensive paediatric patients with mild renal insufficiency because of the risk of hyperkalaemia. (Spironolactone is contraindicated for use in paediatric patients with moderate or severe renal impairment; see section 4.3).
Excipients
Spironolactone tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant use of drugs known to cause hyperkalaemia with spironolactone may result in severe hyperkalaemia. In addition, concomitant use of trimethoprim/sulfamethoxazole (co-trimoxazole) with spironolactone may result in clinically relevant hyperkalaemia.
Spironolactone has been reported to increase serum digoxin concentration and to interfere with certain serum digoxin assays. In patients receiving digoxin and spironolactone the digoxin response should be monitored by means other than serum digoxin concentrations, unless the digoxin assay used has been proven not to be affected by spironolactone therapy. If it proves necessary to adjust the dose of digoxin patients should be carefully monitored for evidence of enhanced or reduced digoxin effect.
Potentiation of the effect of antihypertensive drugs occurs and their dosage may need to be reduced when spironolactone is added to the treatment regime and then adjusted as necessary. Since ACE inhibitors decrease aldosterone production they should not routinely be used with spironolactone, particularly in patients with marked renal impairment.
As carbenoxolone may cause sodium retention and thus decrease the effectiveness of spironolactone concurrent use should be avoided.
Non-steroidal anti-inflammatory drugs such as aspirin, indomethacin and mefenamic acid may attenuate the natriuretic efficacy of diuretics due to inhibition of intrarenal synthesis of prostaglandins and have been shown to attenuate the diuretic effect of spironolactone.
Spironolactone reduces vascular responsiveness to noradrenaline. Caution should be exercised in the management of patients subjected to regional or general anaesthesia while they are being treated with spironolactone.
In fluorimetric assays, spironolactone may interfere with the estimation of compounds with similar fluorescence characteristics.
Spironolactone has been shown to increase the half-life of digoxin.
Spironolactone enhances the metabolism of antipyrine.
Spironolactone can interfere with assays for plasma digoxin concentrations.
Spironolactone binds to the androgen receptor and may increase prostate specific antigen (PSA) levels in abiraterone-treated prostate cancer patients. Use with abiraterone is not recommended.
Spironolactone may reduce mitotane plasma levels in adrenocortical carcinoma patients treated with mitotane and should not be used concomitantly with mitotane.
4.6. Fertility, pregnancy and lactation
Pregnancy
Spironolactone or its metabolites may cross the placental barrier. With spironolactone, feminisation has been observed in male rat fetuses. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus.
Breast-feeding
Metabolites of spironolactone have been detected in breast milk. If use of spironolactone is considered essential, an alternative method of infant feeding should be instituted.
Fertility
Spironolactone may induce impotence and menstrual irregularities (see section 4.8).
4.7. Effects on ability to drive and use machines
Somnolence and dizziness have been reported to occur in some patients. Caution is advised when driving or operating machinery until the response to initial treatment has been determined.
4.8. Undesirable effects
Gynaecomastia may develop in association with the use of spironolactone. Development appears to be related to both dosage level and duration of therapy and is normally reversible when the drug is discontinued. In rare instances some breast enlargement may persist.
The following adverse events have been reported in association with spironolactone therapy:
System Organ Class
Very Common
≥1/10
Common
≥1/100 to < 1/10
Uncommon
≥1/1,000 to < 1/100
Rare
≥1/10,000 to < 1/1,000
Very Rare
< 1/10,000
Frequency Not Known (cannot be estimated from the available data)
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Benign breast neoplasm (male)
Blood and lymphatic system disorders
Agranulocytosis, Leukopenia, Thrombocytopenia
Metabolism and nutrition disorders
Hyperkalaemia
Electrolyte imbalance
Psychiatric disorders
Confusional state
Libido disorder
Nervous system disorders
Dizziness
Gastrointestinal disorders
Nausea
Gastrointestinal disorder
Hepatobiliary disorders
Hepatic function abnormal
Skin and subcutaneous tissue disorders
Pruritus, Rash
Urticaria
Toxic epidermal necrolysis (TEN), Stevens Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS), Alopecia, Hypertrichosis, Pemphigoid
Musculoskeletal and connective tissue disorders
Muscle spasms
Renal and urinary disorders
Acute kidney injury
Reproductive system and breast disorders
Gynaecomastia, Breast pain (male)a
Menstrual disorder, Breast pain (female)b
General disorders and administration site conditions
Malaise
Abbreviations: CDS = Core Data Sheet; F = female; LLT = lower level term; M = male; PT = preferred term; WHO-ART = World Health Organization Adverse Drug Reaction Terminology.
aThe term Breast pain is mapped from CDS and the frequency is derived from WHO-ART term Breast pain (M); however, Breast pain male is the LLT.
bBreast pain is the PT from CDS, and the frequency is derived from WHO-ART term Breast pain (F)
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 website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Acute overdosage may be manifested by drowsiness, mental confusion, nausea, vomiting, dizziness or diarrhoea. Hyponatraemia, or hyperkalaemia may be induced, but these effects are unlikely to be associated with acute overdosage. Symptoms of hyperkalaemia may manifest as paraesthesia, weakness, flaccid paralysis or muscle spasm and may be difficult to distinguish clinically from hypokalaemia. Electrocardiographic changes are the earliest specific signs of potassium disturbances.
Management
No specific antidote has been identified. Improvement may be expected after withdrawal of the drug. General supportive measures including replacement of fluids and electrolytes may be indicated. For hyperkalaemia, reduce potassium intake, administer potassium-excreting diuretics, intravenous glucose with regular insulin or oral ion-exchange resins.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- SPIRONOLACTONA GEMAX PHARMA prescriptionSPIRONOLACTONUM · taken by mouth
- SPIRONOLACTONA BIOEEL 25 mg prescriptionSPIRONOLACTONUM · taken by mouth
- ALSPIRON 25 mg prescriptionSPIRONOLACTONUM · taken by mouth
- ALSPIRON 50 mg prescriptionSPIRONOLACTONUM · taken by mouth
- SPIRONOLACTONA LPH 25 mg prescriptionSPIRONOLACTONUM · taken by mouth
- SPIRONOLACTONA ARENA 25 mg prescriptionSPIRONOLACTONUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- VerospironSpironolactonum · taken by mouth
- Prilactone NextSpironolactonum · taken by mouth
- SpironolSpironolactonum · taken by mouth
- Spironol 100Spironolactonum · taken by mouth
- FinospirSpironolactonum · taken by mouth
- Spironolactone MedregSpironolactonum · taken by mouth
Same active substance. 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 about this leaflet
Ask anything about Spironolactone 12.5 mg Film-coated 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.