Package leaflet: Information for the user
Spironolactone 25mg and 100mg 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
• 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.
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 other ingredients in this medicine (listed in section 6)
if you have Addison’s disease; (a hormone deficiency
characterised by extreme weakness, loss of weight and low
blood pressure)
you have hyperkalaemia (raised blood potassium levels)
you cannot pass urine
• if you have severe kidney disease
• if you are breast-feeding
• if you are taking water tablets (potassium sparing diuretics) or any
potassium supplements
• if you are taking eplerenone (a medicine for high blood pressure).
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 or liver disease. Your doctor will
•
routinely assess you
• if you are pregnant
if you are taking any other water tablets (diuretics) in
combination with Spironolactone Tablets which may cause
low sodium levels (hyponatraemia) in the blood
• if you 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.
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 blood clots)
• medicines for high blood pressure especially ACE inhibitors
•
antipyrine
• other diuretics
•
noradrenaline
• non-steroidal anti-inflammatory drugs (NSAIDs) such as
• medicines known to cause hyperkalaemia (raised blood
aspirin, indometacin, mefenamic acid or ibuprofen
potassium levels)
• potassium supplements
• trimethoprim and trimethoprim-sulfamethoxazole.
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 100 mg per day. In severe cases, Adults over 60 years:
your doctor may increase the dose gradually to 400mg per day. When swelling Your doctor will start you on a low starting dose and
and puffiness of the legs is controlled then a maintenance dose of 75mg to gradually increase the dosage as needed to obtain the
200mg per day may be prescribed.
desired effect, which may be less than the
recommended adult dose.
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 long term treatment at the lowest effective 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 a doctor or go to your nearest hospital casualty department at once. Take any remaining tablets with you and
the container or packaging, so they can be identified. Some signs of overdose are drowsiness, confusion, nausea, vomiting, dizziness and diarrhoea.
If you forget to take Spironolactone Tablets
If you miss a dose, skip it and go back to your regular schedule. Do not take a double dose to make up for a forgotten dose.
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.
Contact your doctor at once if you develop any of the following serious side effects after taking this medicine:
•
Itchiness and blistering of the skin around the lips and rest
of the body (Stevens-Johnson syndrome)
•
Irregular heartbeat, tingling sensation, paralysis or difficulty in
•
Detachment of the top layer of skin from the lower layers of
breathing; which may be symptoms of raised potassium levels
skin, all over the body (toxic epidermal necrolysis)
in your blood. Your doctor will conduct regular blood tests to
•
Skin rash, fever and swelling (which could be symptoms of
monitor potassium and other electrolyte levels. He or she may
something more serious, drug rash and eosinophilia and
stop your treatment if necessary
systemic symptoms)
•
Yellow skin and eyes, itching, abnormal pain and/or
tenderness (jaundice), Spironolactone Tablets can cause
impairment of liver function
Other side effects
•
nausea, stomach upset
• excessive growth of breast tissue in men (gynaecomastia), this
goes away when treatment is stopped, breast lumps, breast pain
•
confusion, dizziness
• skin rashes, generalised itchiness
•
menstrual problems in women
• skin allergy with development of itchiness and weals (urticaria),
•
change in sex drive for both men and women (libido)
excessive hair growth (hypertrichosis), skin condition
•
disturbances in body electrolytes
presenting with fluid-filled blisters (pemphigoid)
•
reduced number of cells that fight infection - white cells
•
hair loss
(leukopenia), reduced number of cells that help with clotting
• general weakness, muscle cramps, tiredness
(thrombocytopenia)
• 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 at: www.mhra.gov.uk/yellowcard. 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
Aver Healthcare Ltd, Unit 6, Salbrook Road Industrial Estate,
Salbrook Road, Salfords, Redhill, RH1 5GJ, United Kingdom
Manufacturer
6 Riverview Road, Beverley, HU17 0LD, U.K
Leaflet last revised April 2017
Spironolactone 100mg Tablets PL 43683/0023
Spironolactone 25mg Tablets PL 43683/0022
SL0102