Aldactone 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aldactone 100 mg film-coated tablets

Spironolactone

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Aldactone 100 mg is and what it is used for
2. What you need to know before taking Aldactone 100 mg
3. How to take Aldactone 100 mg
4. Possible adverse effects
5. How to store Aldactone 100 mg
6. Contents of the pack and other information

1. What Aldactone 100 mg is and what it is used for

This medicine contains spironolactone, which belongs to a group of medicines called diuretics. These are medicines that increase the removal of fluid from the body.

Aldactone is used to reduce high blood pressure (hypertension), swelling due to fluid accumulation (oedema) caused by certain kidney, liver, or heart diseases, and in the treatment of heart failure in combination with other medicines.

It is also used in the diagnosis and treatment of diseases caused by abnormally high production of a natural hormone (aldosterone).

Children should only be treated under the supervision of a paediatrician.

2. What you need to know before taking Aldactone 100 mg

Children with severe renal impairment must not take Aldactone.

Do not take Aldactone 100 mg

• If you are allergic to spironolactone or to any other similar medicine or to any of the other ingredients of this medicine (listed in section 6).
• If you have certain kidney function disorders (acute renal failure, severely impaired kidney function, lack of urine flow to the bladder, or anuria).
• If you have high levels of potassium in your blood.
• If you have a disease called Addison's disease, which causes damage to the adrenal cortex leading to hormonal deficiency.
• If you are being treated with eplerenone (a medicine used to help prevent worsening of heart failure after a myocardial infarction).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Aldactone 100 mg

• If you have severe liver problems, including hepatic cirrhosis.
• If you have diabetes.
• If you have kidney problems, especially children with hypertension, liver problems, severe heart failure, or if you are elderly, the use of spironolactone may alter your blood levels of certain electrolytes; therefore, your doctor will perform periodic monitoring.
• If you are being treated with other medicines used to treat high blood pressure or heart failure (potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II antagonists, aldosterone blockers), or with medicines to prevent blood clotting (heparins), since using these medicines together with Aldactone may lead to increased potassium levels in your blood, which can cause serious problems.
• If you are being treated with non-steroidal anti-inflammatory drugs (for pain and inflammation) or beta-blockers (for treating high blood pressure and other heart problems), since using Aldactone together with these medicines may lead to increased potassium levels in your blood.
• The use of spironolactone with salt substitutes (potassium-containing salt substitutes), potassium-rich diets, or potassium supplements is not recommended, as this may lead to severe poisoning due to increased potassium levels in the blood.
• If you have mild or moderate heart failure, as this medicine may increase your blood potassium levels.
• If you are over 80 years old, your doctor will assess how well your kidneys are functioning.
• Concomitant administration of Aldactone with certain medicines, potassium supplements, and potassium-rich foods may cause severe hyperkalaemia (increased potassium levels in blood). Symptoms of severe hyperkalaemia may include muscle cramps, irregular heartbeat, diarrhoea, nausea, dizziness, or headache.

During treatment with Aldactone, your doctor may carry out periodic tests to monitor your blood electrolyte levels and thereby predict the risk of adverse effects. If you have severe heart failure, your doctor will especially monitor your blood potassium and creatinine levels.

Taking Aldactone 100 mg with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may interact with Aldactone:

• Medicines that may alter potassium levels in blood (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, and potassium supplements).
• The concomitant use of Aldactone with medicines known to increase blood potassium levels may lead to a serious condition of elevated blood potassium.
• Carbenoxolone (used to treat stomach or intestinal ulcers).
• Non-steroidal anti-inflammatory drugs for pain and fever (e.g., aspirin, phenazone, indomethacin, and mefenamic acid).
• Medicines that may alter the body's electrolyte balance (e.g., ammonium chloride, cholestyramine).
• Certain anti-inflammatory medicines (corticosteroids).
• Other medicines that lower blood pressure (antihypertensives).
• Alcohol, barbiturates, narcotics.
• Norepinephrine (noradrenaline), a medicine used in emergency situations to raise blood pressure.
• Digoxin (a medicine to regulate heart rhythm).
• Medicines that reduce blood clotting ability (dicoumarols).
• Lithium: the use of spironolactone may increase lithium blood concentration. If both medicines are administered concomitantly, your doctor must regularly monitor lithium blood levels.
• Trimethoprim and trimethoprim/sulfamethoxazole.

Inform your doctor if you are taking abiraterone for the treatment of prostate cancer.

Inform your doctor if you are taking mitotane for the treatment of malignant adrenal gland tumours. This medicine must not be used together with mitotane.

Interference with diagnostic tests

Aldactone may interfere with the results of certain diagnostic tests. If you are to undergo any diagnostic test to assess digoxin levels, inform your doctor that you are being treated with Aldactone, as it may alter the results.

Taking Aldactone 100 mg with food, drinks, and alcohol

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine, as it may enhance the hypotensive effect of Aldactone.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There is limited data on the use of Aldactone in pregnant women. Your doctor will prescribe Aldactone only if the potential benefit outweighs the potential risk.

Breastfeeding

Aldactone must not be used if you are breastfeeding your child. You should discuss the use of Aldactone with your doctor, who will advise you to consider an alternative method of feeding your baby while taking this medicine.

Fertility

Women of childbearing potential should use appropriate contraceptive measures.

Use in athletes

This medicine contains spironolactone, which may result in a positive test in doping controls.

Driving and using machines

Aldactone may cause drowsiness and dizziness, especially at the beginning of treatment. If you experience these effects, consult your doctor before performing such activities. Do not operate tools or machinery if your ability to do so is affected by this medicine.

3. How to take Aldactone 100 mg

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended initial dose of Aldactone in the treatment of high blood pressure is 50 to 100 mg daily. Your doctor will adjust the dose at intervals of 2 weeks or more, and may increase it up to 200 mg daily.

In the case of heart failure, the usual initial dose is 25 mg daily. Your doctor may increase or decrease the dose as necessary to reach the dose appropriate for you. The dose should not exceed 50 mg daily.

The maximum dose of Aldactone is 400 mg daily.

Use in children

In children, the dose may be administered only if the child is able to swallow the tablets.

Aldactone tablets may be taken at any time of day, with or without food. However, try to take your tablet at the same time every day.

Your doctor will decide the duration of treatment with Aldactone 100 mg.

Ask your doctor if you think that the effect of Aldactone 100 mg is too strong or too weak.

If you take more Aldactone 100 mg than you should

An overdose of Aldactone may cause drowsiness, mental confusion, low blood pressure, changes in heart rhythm, nausea, vomiting, diarrhoea, skin rash, dehydration, and disturbances in electrolyte levels.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Aldactone 100 mg

If you forget to take a dose, take the next scheduled dose at the correct time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Aldactone 100 mg

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects are important and, if you experience any of them, immediate action will be required:

• Occasionally, patients have developed disturbances in blood electrolytes, and very rarely this has led to a serious, potentially life-threatening condition (called hyperkalemia). If you experience disturbances in heart rhythm, tingling sensation, muscle weakness, flaccid paralysis, or muscle spasms, stop taking Aldactone immediately and contact your doctor without delay.

Very common adverse effects (may affect more than 1 in 10 patients):

• Increased potassium levels in the blood (hyperkalemia)

Common adverse effects (may affect up to 1 in 10 patients):

• Confusion
• Dizziness, headache, drowsiness
• Diarrhea, nausea
• Itching, skin rash, redness
• Leg cramps
• Acute kidney injury
• Excessive breast development in men (gynecomastia), menstrual disturbances (irregularities, amenorrhea, postmenopausal bleeding), impotence, breast pain in men
• Malaise, fatigue

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Benign breast tumors in men
• Disturbances in blood electrolytes, decreased sodium levels
• Tingling sensation (paresthesia)
• Liver function abnormalities
• Urticaria (hives)
• Increased blood creatinine concentration
• Breast pain in women

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Decreased number of neutrophils in the blood (agranulocytosis), decreased number of white blood cells (leukopenia), decreased number of platelets in the blood (thrombocytopenia)
• Acute kidney failure

Very rare adverse effects (may affect up to 1 in 10,000 patients):

• Benign breast tumors
• Changes in libido
• Lack of coordination of movement (ataxia)
• Hair loss (alopecia), excessive hair growth (hypertrichosis)

Adverse effects with unknown frequency (cannot be estimated from available data):

• Gastrointestinal disorders
• Serious skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms)
• Pemphigoid (a disease causing fluid-filled blisters on the skin)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aldactone 100 mg

Keep this medicine out of the sight and reach of children.

This medicine requires no special storage conditions.

Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aldactone 100 mg

The active substance in Aldactone is spironolactone. Each tablet contains 100 mg of spironolactone.

The other components are: calcium sulfate dihydrate, corn starch, povidone K-30, peppermint flavor, and magnesium stearate.

The coating of Aldactone contains: hydroxypropylmethylcellulose 2910, polyethylene glycol 400, and Opadry 06B280002 (white).

Appearance of the product and contents of the pack

Aldactone 100 mg film-coated tablets are white, round, and scored.

Aldactone 100 mg is available in cartons with blisters containing 20 film-coated tablets and in hospital packs containing 500 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Manufacturer:

Farmasierra Manufacturing, S.L.

Carretera de Irún, Km. 26,200

28709 San Sebastián de los Reyes (Madrid).

Date of the most recent revision of this leaflet: November 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es