Patient Leaflet Updated 12-Feb-2024 | ADVANZ Pharma
Spironolactone 12.5 Film-coated Tablets
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
(spironolactone)
Your medicine is called spironolactone 12.5, 25, 50, 100 mg film-coated tablets, but it will be referred to as spironolactone tablets throughout this leaflet.
1. What spironolactone tablets are and what they are used for
2. What you need to know before you take spironolactone tablets
3. How to take spironolactone tablets
4. Possible side effects
5. How to store spironolactone tablets
6. Contents of the pack and other information
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:
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.
Children with moderate to severe kidney disease must not take spironolactone.
Talk to your doctor or pharmacist before taking Spironolactone tablets
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.
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:
Tell your doctor, if you are using abiraterone for treatment of prostate cancer
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.
See section 3 “How to take spironolactone tablets”
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.
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.
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.
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.
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.
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 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 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.
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.
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
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Not known: frequency cannot be estimated from the available data
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.
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.
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
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.
This leaflet was last revised in January 2024.
PL 12762/0544
PL 12762/0545
PL 12762/0546
PL 12762/0547
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+44 (0)208 588 9131
www.advanzpharma.com
+44 (0)208 588 9131
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