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Active substance(s): SPIRONOLACTONE

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Package leaflet: Information for the patient

Aldactone® 100mg,
50mg and 25mg Tablets

Aldactone 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
Aldactone 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 Aldactone.
You can also take Aldactone for the following illnesses:
● ‘Nephrotic syndrome’ - a kidney disorder that causes too much fluid in your body
● ‘Ascites’ - too much fluid in your abdomen, for example caused by cirrhosis of the liver
● ‘Primary aldosteronism’ - extra fluid in your body caused by too much of a hormone
called ‘aldosterone’.
If you have these illnesses, Aldactone 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.
2. What you need to know before you take Aldactone


Do not take Aldactone if:
● you are allergic to spironolactone or any of the other ingredients of this medicine (listed
in section 6)
● you have Addison’s disease; (a hormone deficiency characterised by extreme
weakness, loss of weight and low blood pressure)
● you have hyperkalaemia (raised blood potassium levels)
● you cannot pass urine
● you have severe kidney disease
● you are breast-feeding
● you are taking water tablets (potassium sparing diuretics) or any potassium
● you are taking eplerenone (a medicine for high blood pressure).
Children with moderate to severe kidney disease must not take Aldactone
Warnings and precautions
Talk to your doctor or pharmacist before taking Aldactone if:
● you suffer from kidney disease especially children with hypertension or liver disease.
Your doctor will routinely assess you.
● you are pregnant
● you are taking any other water tablets (diuretics) in combination with Aldactone which
may cause low sodium levels (hyponatraemia) in the blood
● you have a diet rich in potassium or salt substitutes containing potassium.
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.
Other medicines and Aldactone
Please tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without prescription. Your doctor may
wish to alter your dose of Aldactone if you are taking any of the following:
● digoxin or carbenoxolone
● medicines for high blood pressure including angiotensin-converting enzyme (ACE)
● other diuretics
● non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, indometacin,
mefenamic acid or ibuprofen
● potassium supplements
● heparin or low molecular weight heparin (medicines used to prevent blood clots)
● antipyrine
● noradrenaline
● medicines known to cause hyperkalaemia (raised blood potassium levels)
If you are going to have an operation where you will be given an anaesthetic, tell the
doctor in charge that you are taking Aldactone.
Aldactone with food, drink and alcohol
This medicine should be taken with food (see section 3 ‘How to take Aldactone’)
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Aldactone should not be used if you are breast-feeding.
You should discuss the use of Aldactone 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 Aldactone treatment and may affect your ability to drive or operate
machinery safely.
3. How to take Aldactone
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.
This medicine should be taken once a day with food.
The adult dose varies from 25mg to 200mg spironolactone a day. If you are not sure how
much to take, ask your doctor or pharmacist.
Your doctor will start you on a low starting dose and gradually increase the dosage as
needed to obtain the desired effect.


Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your doctor or pharmacist.
● This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
● If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Aldactone is and what it is used for
2. What you need to know before you take Aldactone
3. How to take Aldactone
4. Possible side effects
5. How to store Aldactone
6. Contents of the pack and other information
1. What Aldactone is and what it is used for

Use in children and adolescents
If you are giving Aldactone 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 Aldactone than you should
If you accidentally take too many tablets, contact your doctor or nearest hospital accident
department immediately. The symptoms of an overdose are feeling drowsy and dizzy. You
may also feel or be sick or may suffer from diarrhoea.
If you forget to take Aldactone
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 missed dose.
If you stop taking Aldactone
It is important to keep taking Aldactone 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
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
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 (StevensJohnson 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), Aldactone can cause impairment of liver function
● Irregular heartbeat, tingling sensation, paralysis 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. He or she may stop your
treatment if necessary.
Other side effects of Aldactone
● Nausea, stomach upset
● Confusion, dizziness
● Menstrual problems in women
● Change in sex drive for both men and women (libido)
● Disturbances in body electrolytes
● Reduced number of cells that fight infection - white cells (leukopenia), reduced number
of cells that help with clotting (thrombocytopenia)
● Excessive growth of breast tissue in men (gynaecomastia), this goes away when
treatment is stopped, breast lumps, breast pain
● Skin rash, generalised itchiness
● Skin allergy with development of itchiness and weals (urticaria), excessive hair growth
● Hair loss
● General weakness, muscle cramps
● Sudden kidney failure
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 (see
details below). By reporting side effects you can help provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme website:
ADR Reporting
5. How to store Aldactone
● Keep this medicine out of the sight and reach of children
● Keep your tablets in a dry place, below 30°C
● Do not use this medicine after the expiry date which is stated on the carton 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 to
protect the environment.
6. Contents of the pack and other information
What Aldactone contains
The active substance is spironolactone. Each Aldactone 25mg tablet contains 25mg of
spironolactone. Aldactone 50mg tablets contain 50mg of spironolactone and Aldactone
100mg tablets contain 100mg spironolactone.
The other ingredients are calcium sulfate dihydrate, corn starch, polyvinylpyrrolidone,
magnesium stearate, felcofix peppermint, hypromellose, polyethylene glycol and
opaspray yellow (E171 and E172).
Aldactone 50mg contains opaspray white (E171) instead of opaspray yellow.
What Aldactone looks like and the contents of the pack
The name of your medicine is Aldactone.
The Aldactone 25 mg tablets are buff, film coated tablets engraved “SEARLE 39” on one side.
The Aldactone 50mg tablets are white, film-coated tablets engraved “SEARLE 916” on one side.
The Aldactone 100mg tablets are buff, film coated tablets engraved “SEARLE 134” on one side.
Aldactone 25mg tablets come in packs of 50, 100,
500 and 1000 tablets.
Aldactone 50mg tablets come in packs of 50, 100 and 500 tablets.
Aldactone 100mg tablets come in packs of 50, 100, 500, 1000 and calendar packs of
28 tablets.
All pack sizes may not be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Limited,
Ramsgate Road,
CT13 9NJ,
United Kingdom
Piramal Healthcare UK Limited,
NE61 3YA
This leaflet was last revised in 10/2015
Ref: AN 10 0

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.