Patient leaflet - ALDACTONE 100 MG FILM-COATED TABLETS
^™^^R1. What Aldactone is and what it is used for
Aldactone contains the active substance spironolactone. Aldactone 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 Aldactone 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 Aldactone.
You can also take Aldactone for the following illnesses:
- ‘ Nephrotic syndrome’ – a kidney disorder that causes too much fluid in your body
- Ascites’ – too much fluid in your abdomen and ‘oedema’ -accumulation of fluid beneath skin or in one or more cavities of the body that produces swelling, 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, Aldactone 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 Aldactone
Do not take Aldactone if:
- you are allergic to spironolactone or any of the other ingredients of this medicine (listed in section 6)
- you cannot pass urine
- you have severe kidney disease
- 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 are breast-feeding
- you 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 Aldactone.
Warnings and precautions
Talk to your doctor or pharmacist before taking Aldactone if:
- you suffer from kidney disease especially children with hypertension or liver disease. Your doctor will routinely assess you particularly if you are elderly
- you have difficulty passing urine
- you have a disease that can result in electrolyte balance disturbance in your blood such as potassium or sodium
- you have severe heart failure
- you are pregnant
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 Aldactone 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 Aldactone
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 Aldactone if you are taking any of the following:
- digoxin or carbenoxolone
- medicines for high blood pressure including angiotensinconverting enzyme (ACE) inhibitors
- other diuretics
- non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, indomethacin, mefenamic acid or ibuprofen
- potassium supplements
- heparin or low molecular weight heparin (medicines used to prevent blood clots)
- antipyrine
- medicines known to cause hyperkalaemia (raised blood potassium levels)
- t rimethoprim and trimethoprim-sulfamethoxazole Aldactone 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 Aldactone.
Tell your doctor, if you are using abiraterone for treatment of prostate cancer.
Aldactone with food, drink and alcohol
See section 3 ‘How to take Aldactone’.
Pregnancy, breast-feeding and fertility
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. Aldactone should not be used if you are breastfeeding. You should discuss the use of Aldactone with your doctor, who will advise you to consider an alternative method of feeding your baby while you are taking this medicine.
Driving and using machines
Take care if you drive or operate machinery. Drowsiness and dizziness have been associated with Aldactone treatment and this may affect your ability to drive or operate machinery safely.
3. How to take Aldactone
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.
Recommended dose
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.
Use in 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
- Hair loss
- Excessive hair growth
5. how to store aldactone
Keep this medicine out of the sight and reach of children.
Do not store your tablets above 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 sulfate 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 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
UK
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
Malta
Pfizer Hellas S.A., 243 Messoghion Ave, N. Psychiko, Greece.
Manufacturer
Piramal Healthcare UK Limited
Morpeth
Northumberland
NE61 3YA
This leaflet was last revised in 02/2022
Ref: AN 19_0
20769067