Patient leaflet - Spironolactone 25 mg tablets
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
Do not take Spironolactone Tablets:
- if you are allergic to spironolactone, other diuretics or to any of the • if you have severe kidney disease other ingredients in this medicine (listed in section 6) • if you are breast-feeding
- if you have Addison’s disease; (a hormone deficiency characterised by • if you are taking water tablets (potassium sparing diuretics) or any extreme weakness, loss of weight and low blood pressure) potassium supplements
- you have hyperkalaemia (raised blood potassium levels) • if you are taking eplerenone (a medicine for high blood pressure).
- you cannot pass urine
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 • heparin or low molecular weight heparin (medicines used to prevent
- medicines for high blood pressure especially ACE inhibitors blood clots)
- other diuretics • antipyrine
non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, • noradrenaline
indometacin, mefenamic acid or ibuprofen • medicines known to cause hyperkalaemia (raised blood potassium levels)
- potassium supplements • 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 100mg 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 100mg and 400mg per day.
Nephrotic syndrome: The usual dose is 100mg 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 100mg 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.
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
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 at: 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.
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 information What Spironolactone Tablets contain
The active ingredient (which makes the tablets work) is spironolactone. The 25mg tablets contain 25mg of spironolactone. The 100mg tablets contain 100mg of spironolactone. The tablets also contain: calcium sulphate dihydrate, povidone, maize starch, crospovidone, pregelatinised maize starch, magnesium stearate, peppermint flavour and quinoline yellow E104.
What Spironolactone Tablets look like and contents of the pack
Spironolactone 25mg Tablets are pale yellow, bi-convex tablets engraved with SPR25. Spironolactone 100mg Tablets are pale yellow, bi-convex tablets engraved with SPR100. Both 25mg and 100mg 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:
Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, United Kingdom.
Leaflet last revised in November 2021.
Spironolactone 25mg Tablets: PL 20395/0309 Spironolactone 100mg Tablets: PL 20395/0310
PRODUCT NAME
PRODUCT LICENCE NO.
STRENGTH
PACK SIZE
FONT & SIZE
REMARKS
REASON FOR CHANGE
COUNTRY MANUFACTURER
SOFTWARE
ARTIST Spironolactone Tablets
20395-0309, 0310
PIL
210 x 300 mm
25 mg & 100 mg
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Garamond (12 pt, 9pt)
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“75mg to 200 mg” replaced with “25mg to 200mg” under Adults
UK (English)
Steril Gene
Adobe illustrator CC
Santosh
NO. OF COLORS 01
██ Black
1.4
VERSION XXXXXXX DATE 11.11.2021