SPIRONOLACTONE 25 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - SPIRONOLACTONE 25 MG TABLETS

Spironolactone 25mg and lOOmg Tablets

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 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

1. What Spironolactone Tablets are and what they are used for

Spironolactone belongs to a group of medicines called potassium-sparing diuretics (‘water tablets’). They are used to help reduce the build up of too much fluid in the body (oedema) in the following conditions:

Nephrotic syndrome — a kidney disorder that causes too much fluid in your body
Heart failure
Ascites — too much fluid in your abdomen, 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 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.

2. what you need to know before you take spironolactone tablets

Children with moderate to severe kidney disease must not take Spironolactone Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Spironolactone Tablets:

if you suffer from kidney disease especially children with hypertension if you have difficulty passing urine
or liver disease. Your doctor will routinely assess you particularly if you have disease that can result in electrolyte balance disturbance in

if you are elderly your blood such as potassium or sodium

if you are pregnant if you have severe heart failure

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 Tablets 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 Tablets

Please 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 Tablets if you are taking any of the following:

digoxin or carbenoxolone
medicines for high blood pressure especially 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)
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 your doctor or surgeon that you are taking Spironolactone Tablets.

Spironolactone Tablets with food and drink

This medicine should be taken with food (see section 3 ‘How to take Spironolactone Tablets’).

Pregnancy and breast-feeding

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 Tablets with your doctor, who will advise you to consider an alternative method of feeding your baby while taking this medicine.

Driving and using machines

Take care if you drive or operate machinery. Drowsiness and dizziness have been associated with spironolactone treatment and may affect your ability to drive or operate machinery safely.

3. how to take spironolactone tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You will be prescribed the lowest dose needed to control your symptoms. Do not stop taking the medicine or change the dose unless your doctor tells you to. If you stop taking the tablets too soon your condition may get worse.

Swallow the tablets with a glass of water.

Adults:

Congestive heart failure: The usual dose is lOOmg per day. In severe cases, your doctor may increase the dose gradually to 400mg per day When swelling and puffiness of the legs is controlled then a maintenance dose of 25mg to 200mg per day may be prescribed.

Cirrhosis of the liver: The usual dose is between lOOmg and 400mg per day.

Nephrotic syndrome: The usual dose is lOOmg to 200mg per day. Use of spironolactone is only advised if other medicines by themselves are not effective.

Primary aldosteronism: Your doctor may use spironolactone to diagnose this condition. If a diagnosis is made, then the doctor may decide to treat the condition by surgery, in which case the usual dose is from lOOmg to 400mg daily. For patients who are unsuitable for surgery, spironolactone may be used for longer term treatment at the lowest effective dose.

Adults over 60 years: Your doctor will start you on a low starting dose and gradually increase the dosage as needed to obtain the desired effect, which may be less than the recommended adult dose.

Use in Children: 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 you should give.

If you take more Spironolactone Tablets than you should

If you accidentally take too many tablets, contact your doctor or go to your nearest hospital casualty department. Take any remaining tablets with you and the container or packaging, so they can be identified. 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 Tablets

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 Spironolactone Tablets

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.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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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)
Skin rash, fever and swelling (which could be symptoms of something more serious, drug rash with eosinophilia and systemic symptoms)
Yellow skin and eyes (jaundice), Spironolactone Tablets 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.

List of other side effects of Spironolactone Tablets by frequency:

Very Common: may affect more than 1 in 10 people

Raised potassium in the blood

Common: may affect up to 1 in 10 people

Confusion, Dizziness
Vomiting or feeling sick
Itching of the skin, Rash
Muscle or leg cramps
Kidney failure or abnormal function
Breast enlargement in men, Breast pain (in men)
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

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
Change in sex drive for both men and women
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 Ha the Yellow Card Scheme at: wwwmhra.govuk/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.

5. how to store spironolactone tablets

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Keep the container tightly closed (for containers). Store in the original package (for blisters). Do not use this medicine after the expiry date which is stated on the packaging 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.

6. contents of the pack and other informationwhat spironolactone tablets containthe active ingredient (which makes the tablets work) is spironolactone. the 25mg tablets contain 25mg of spironolactone. the loomg tablets contain loomg of spironolactone. the tablets also contain: calcium sulphate dihydrate, povidone, maize starch, crospovidone, pregelatinised maize starch, magnesium stearate, peppermint flavour and quinoline yellow el04.

What Spironolactone Tablets look like and contents of the pack

Spironolactone 25mg Tablets are pale yellow, bi-convex tablets engraved with SPR25. Spironolactone lOOmg Tablets are pale yellow, bi-convex tablets engraved with SPR100. Both 25mg and lOOmg strengths are available in pack sizes of 28, 30, 50, 56, 60, 84,100, 250, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Spironolactone 25mg Tablets: PL 20395/0309

Spironolactone lOOmg Tablets: PL 20395/0310

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, United Kingdom.

Leaflet last revised in November 2021.

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