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ALDACTONE 100MG TABLETS

Active substance(s): SPIRONOLACTONE

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Package leaflet: Information for the
patient

• y ou 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
25mg, 50mg and Aldactone.
Warnings and precautions
Talk to your doctor or pharmacist before taking Aldactone if:
100mg
• you suffer from kidney disease especially children with
(spironolactone)
hypertension or liver disease. Your doctor will routinely assess
you particularly if you are elderly
Read all of this leaflet carefully before you start
taking this medicine because it contains important • you have difficulty passing urine
• you have a disease that can result in electrolyte balance
information for you.
disturbance in your blood such as potassium or sodium
• Keep this leaflet. You may need to read it again.
• you have severe heart failure
• If you have any further questions, ask your doctor or
• you are pregnant
pharmacist.
• This medicine has been prescribed for you only. Do not pass If you experience reduced kidney function or kidney failure you may
have severe increases in the levels of potassium in your blood. This
it on to others. It may harm them, even if their signs of illness
can affect the way your heart functions and in extreme cases this
are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. can be fatal.
Concomitant administration of Aldactone with certain medicines,
This includes any possible side effects not listed in this leaflet.
potassium supplements and food rich in potassium may lead
See section 4.
to severe hyperkalaemia (increased potassium blood level). The
What is in this leaflet:
symptoms of severe hyperkalaemia might include muscle cramps,
1. What Aldactone is and what it is used for
irregular heart rhythm, diarrhoea, nausea, dizziness or headache.
2. What you need to know before you take Aldactone
Other medicines and Aldactone
3. How to take Aldactone
Tell your doctor or pharmacist if you are taking, have recently
4. Possible side effects
taken or might take any other medicines, including medicines
5. How to store Aldactone
obtained without prescription. Your doctor may wish to alter your
6. Contents of the pack and other information
dose of Aldactone if you are taking any of the following:
1. What Aldactone is and what it is used for
• digoxin or carbenoxolone
Aldactone contains the active substance spironolactone. Aldactone • medicines for high blood pressure including angiotensinconverting enzyme (ACE) inhibitors
belongs to a group of medicines called ‘diuretics’ – you may know
these as ‘water’ tablets. You may have gone to your doctor because • other diuretics
• non-steroidal anti-inflammatory drugs (NSAIDs) such as
you had swollen ankles or were short of breath. This can happen
aspirin, indomethacin, mefenamic acid or ibuprofen
when your heart’s pumping action has become weak because of
too much fluid in your body. This is called ‘congestive heart failure’. • potassium supplements
Pushing extra fluid around your body means your heart has to work • heparin or low molecular weight heparin (medicines used to
prevent blood clots)
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 • antipyrine
work. You lose the extra fluid as urine, so you may need to go to the • medicines known to cause hyperkalaemia (raised blood
potassium levels)
toilet more often while you are taking Aldactone.
• trimethoprim and trimethoprim-sulfamethoxazole
You can also take Aldactone for the following illnesses:
Aldactone reduces your responsiveness to noradrenaline. If you are
• ‘Nephrotic syndrome’ - a kidney disorder that causes too
going to have an operation where you will be given an anaesthetic,
much fluid in your body
tell the doctor in charge that you are taking Aldactone.
• ‘Ascites’ - too much fluid in your abdomen and ‘oedema’ Aldactone with food, drink and alcohol
accumulation of fluid beneath skin or in one or more cavities
See section 3 ‘How to take Aldactone’.
of the body that produces swelling, for example caused by
Pregnancy, breast-feeding and fertility
cirrhosis of the liver
• ‘Malignant ascites’- fluid containing cancer cells that collect 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
in the abdomen
• ‘Primary aldosteronism’ - extra fluid in your body caused by this medicine. Aldactone should not be used if you are breastfeeding. You should discuss the use of Aldactone with your doctor,
too much of a hormone called ‘aldosterone’.
If you have these illnesses, Aldactone will help your body to get who will advise you to consider an alternative method of feeding
your baby while you are taking this medicine.
rid of the extra fluid. You must talk to a doctor if you do not feel
Driving and using machines
better or if you feel worse.
Take care if you drive or operate machinery. Drowsiness and
Children should only be treated under guidance of a paediatric
dizziness have been associated with Aldactone treatment and this
specialist.
2. What you need to know before you take Aldactone may affect your ability to drive or operate machinery safely.
3. How to take Aldactone
Do not take Aldactone if:
Always take this medicine exactly as your doctor or pharmacist
• you are allergic to spironolactone or any of the other
has told you. Check with your doctor or pharmacist if you are
ingredients of this medicine (listed in section 6)
not sure. The pharmacist’s label on the pack also gives this
• you cannot pass urine
information. The number of tablets you need to take depends on
• you have severe kidney disease
your illness. This medicine should be taken once a day with food.
• you have Addison’s disease; (a hormone deficiency
characterised by extreme weakness, loss of weight and low Adults
The adult dose varies from 25mg to 400mg spironolactone a
blood pressure)
day, depending on the condition being treated. If you are not
• you have hyperkalaemia (raised blood potassium levels)
sure how much to take, ask your doctor or pharmacist.
• you are breast-feeding

Aldactone®
Tablets

Elderly
Your doctor will start you on a low starting dose and gradually
increase the dosage as needed to obtain the desired effect.
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 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 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 forgotten 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 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 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 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), skin
condition presenting with fluid-filled blisters (pemphigoid)
• Hair loss
• General weakness, muscle or leg cramps
• Sudden kidney failure or abnormal liver function
• Raised potassium in the blood (hyperkalaemia)

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: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
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 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 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. Each Aldactone 50mg
tablet contains 50mg of spironolactone and each Aldactone
100mg tablet contains 100mg spironolactone.
The other ingredients are calcium sulphate dihydrate, corn
starch, polyvinyl pyrrolidone, magnesium stearate, felcofix
peppermint, hypromellose, polyethylene glycol. Aldactone 25mg
and Aldactone 100mg tablets contain Opaspray yellow (E171 and
E172). Aldactone 50mg tablets contain Opaspray white (E171).
What Aldactone looks like and the contents of the pack
Aldactone 25mg tablets are buff, film coated tablets engraved
“SEARLE 39” on one side.
Aldactone 50mg tablets are white, film-coated tablets engraved
“SEARLE 916” on one side.
Aldactone 100mg tablets are buff, film coated tablets engraved
“SEARLE 134” on one side.
Aldactone 25mg tablets come in amber glass or plastic bottles
and PVC/foil blister packs containing 100 or 500 tablets; HDPE
containers of 50 or 1,000 tablets and PVC/foil calendar packs
of 28 tablets.
Aldactone 50mg tablets come in amber glass or plastic bottles
and PVC/foil blister packs of 50, 100 or HDPE containers of 50,
100 or 500 tablets.
Aldactone 100mg tablets come in amber glass or plastic bottles
and PVC/foil blister packs containing 100 or 500 tablets; HDPE
containers of 50 or 1,000 tablets and PVC/foil calendar packs of
28 tablets. All pack sizes may not be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
Manufacturer
Piramal Healthcare UK Limited
Morpeth
Northumberland
NE61 3YA
This leaflet was last revised in 04/2016
Ref: AN 16_0
20716023

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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.

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