Patient leaflet - Spironolactone 50 mg tablets
What Spironolactone is and what it is used for
Spironolactone belongs to a group of medicines called
diuretics (you may know these as ‘water’ tablets, which
increase the amount of urine passed. 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
Spironolactone 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 also 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’.
If you have these illnesses, Spironolactone 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
Spironolactone
Do NOT take Spironolactone if you:
you are allergic to spironolactone or any of the
other ingredients of this medicine (listed in section 6)
- you cannot pass urine
- you have severe kidney disease
you have hyperkalaemia (raised blood potassium
levels)
you have Addison's disease (a hormone deficiency
characterised by extreme weakness, loss of weight
and low blood pressure)
you are breast-feeding
you are taking ‘water tablets’ (potassium sparing
diuretics) or any potassium supplements
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 if:
you suffer from kidney disease especially children
with hypertension or liver disease. Your doctor will
routinely assess you particularly if you are elderly
- you have difficulty passing urine
you have a disease that can result in electrolyte
balance disturbance in your blood such as
potassium or sodium
- you have severe heart failure
- 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may wish to alter your dose of Spironolactone 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 (NASIDs), such as aspirin, indometacin, mefenamic acid or ibuprofen
- potassium supplements
- heparin or low molecular weight heparin (medicines used to prevent blood clots)
- antipyrine
- medicines known to cause hyperkalaemia (raised blood potassium levels)
- trimethoprim and trimethoprim-sulfamethoxazole 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. 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 with food, drink and alcohol
See section 3 ‘How to take Spironolactone’. 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.
Pregnancy
There are limited data from the use of spironolactone in pregnant women. Your doctor will only prescribe Spironolactone if the potential benefit outweighs the potential risk.
Breast-feeding
Spironolactone should not be used if you are breast-feeding. You should discuss the use 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 drive or operate machinery. Drowsiness and dizziness have been associated with Spironolactone treatment and this may affect your ability to drive or operate machinery safely. Important information about some of the ingredients of Spironolactone
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
How to take Spironolactone
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 25 mg to 400 mg of Spironolactone a day, depending on the condition being treated. If you are not sure how much to take, ask your doctor or pharmacist.
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What is in this leaflet
Package leaflet: Information for the patient
IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier. We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.
SKU (s): 231-10-07058 32104747
231-10-07078 32104761
231-10-07068
(excluding codes) Perforated: Univers. 9 pt TevaArt Ref: PID: 234990_s1 P: Spironolactone UK Tablets 25mg 50mg 100mg 28 DEB 8 October 2025
Version: 3
Length:
Width:
Depth:
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BLACK 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 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 than you should
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
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. Take the remaining doses at the correct time. If you stop taking Spironolactone
It is important to keep taking Spironolactone 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, red or purple rash spreading and forming blisters (Stevens-Johnson syndrome)
- detachment of the top layer of skin from the lower layers of skin, all over the body (toxic epidermal necrolysis - TEN)
- skin rash, fever and swelling (which could be symptoms of something more serious, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
- yellow skin and eyes (jaundice)
- Spironolactone 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
Very common: may affect more than 1 in 10 people
- raised potassium level in the blood (hyperkalaemia). Common: may affect up to 1 in 10 people
- vomiting or feeling sick
- rash
- abdominal pain, diarrhoea
- headache
- confusion
- itching of the skin
- dizziness
- muscle or leg cramps
- kidney failure or abnormal function
- breast pain in men
- breast enlargement in men
- liver problems (hepatotoxicity)
- feeling generally unwell.
Uncommon: may affect up to 1 in 100 people
- changes in the breast, such as breast lumps
- disturbances in body electrolytes such as high blood calcium
- abnormal functioning of the liver
skin allergy with development of itchiness and hives, nettle like rash
- menstrual problems in women
- breast pain (in women).
Not known: frequency cannot be estimated from the available data
- change in sex drive for both men and women (libido)
- lowered white blood cell count in blood
- reduced number of cells that fight infection - white blood cells which make infections more likely
- reduced number of cells that help with blood clotting which increases risk of bleeding or bruising
- digestion problems, stomach upset
- skin condition presenting with fluid-filled blisters (pemphigoid)
- hair loss
- excessive hair growth.
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 App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Spironolactone
Keep this medicine out of the sight and reach of children.
Store below 25°C, protected from light, in the package or container supplied. Do not use this medicine after the expiry date which is stated on the blister, carton or bottle 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 25 mg, 50 mg or 100 mg.
The other ingredients are colloidal anhydrous silica, sodium laurilsulfate, lactose monohydrate, microcrystalline cellulose (E460), rice starch, povidone (E1201), peppermint oil, magnesium stearate, hypromellose (E464), polyethylene glycol and the colours titanium dioxide (E171) and iron oxide (E172).
In addition to these ingredients the 25 mg tablets contain agar (E460) and talc (E553b), the 50 mg tablets contain agar (E460), and the 100 mg tablets contain sodium starch glycolate, menthol and talc (E553b).
What Spironolactone looks like and contents of the pack
- The 25 mg tablet is a buff coloured biconvex film-coated tablet marked "APS" or plain on one side and "25 0705" on the reverse.
- The 50 mg tablet is a buff coloured biconvex film-coated tablet marked “APS” or plain on one side and “50 0707” on the reverse.
- The 100 mg tablet is a buff coloured biconvex film-coated tablet marked "APS" or plain on one side and "100 0706" on the reverse.
The product is available in pack sizes of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160 and 168 tablets. The 25 mg and 50 mg strength tablets are also available in a pack size of 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom.
Manufacturer
TEVA Pharmaceutical Works Private Limited Company, Pallagi street 13, Debrecen, H-4042, Hungary.
This leaflet was last revised in October 2025.
PL 00289/0071-72, PL00289/0136
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