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Active substance(s): SPIRONOLACTONE

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Package leaflet: Information for the patient

Aldactone®(spironolactone) 25mg Tablets
100mg, 50mg and
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.
●  you have any further questions, ask your doctor or pharmacist.
●  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.
●  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.  hat 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
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
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.
2. What you need to know before you take Aldactone
Do not take Aldactone if:
●  are allergic to spironolactone or any of the other
ingredients of this medicine (listed in section 6)
●  have Addison’s disease; (a hormone deficiency
characterised by extreme weakness, loss of weight
and low blood pressure)
●  have hyperkalaemia (raised blood potassium
● you cannot pass urine
● you have severe kidney disease
● you are breast-feeding
●  are taking water tablets (potassium sparing
diuretics) or any potassium supplements
●  are taking eplerenone (a medicine for high blood
Warnings and precautions
Talk to your doctor or pharmacist before taking Aldactone if:
●  suffer from kidney or liver disease. Your doctor will
routinely assess you.

● you are pregnant
●  are taking any other water tablets (diuretics) in
combination with Aldactone which may cause low
sodium levels (hyponatraemia) in the blood
●  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) inhibitors
● 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.
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 pharmacist.
4. 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
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 (hypertrichosis)
● 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 via
the Yellow Card Scheme website:
yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Aldactone
Keep this medicine out of the sight and reach of
Keep your tablets in a dry place, below 30°C
●  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 sulphate 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 01/2015
Ref: AN 9_1

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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.