Prospecto: information for the user

Aldactone 100 mg film-coated tablets

Espironolactona

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

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

2.What you need to know before starting to take Aldactone 100 mg

3.How to take Aldactone 100 mg

4.Possible adverse effects

5.Storage of Aldactone 100 mg

6.Contents of the package and additional information

This medication contains spironolactone which belongs to a group of medicines called diuretics. These are medicines that increase the elimination of liquids from the body.

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

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

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

Children with severe kidney failure should not take Aldactone.

Do not take Aldactone 100 mg

• If you are allergic to spironolactone or any other similar medication or to any of the other components of this medication (listed in section 6).
• If you have certain kidney function disorders (acute kidney failure, severely impaired kidney function, inability to urinate, or anuria).
• If you have high levels of potassium in your blood.
• If you have a condition called Addison's disease, which causes damage to the adrenal cortex resulting in hormonal deficiency.
• If you are being treated with eplerenone (a medication used to help prevent the worsening of heart failure after a heart attack).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Aldactone 100 mg.

• If you have severe liver problems, including cirrhosis.
• If you are diabetic.
• 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, so your doctor will perform regular checks.
• If you are being treated with other medications used to treat high blood pressure or heart failure (diuretics that retain potassium, angiotensin-converting enzyme inhibitors (ACE inhibitors)), angiotensin II antagonists, or beta-blockers), as the concurrent use of these medications with Aldactone may lead to an increase in your blood potassium levels that can cause serious problems.
• If you are being treated with anti-inflammatory non-steroidal medications (for pain and inflammation) or beta-blockers (for the treatment of high blood pressure and other heart problems), as the concurrent use of Aldactone with these medications may lead to an increase in your blood potassium levels.
• Do not recommend the use of spironolactone with salt substitutes (potassium-containing salt substitutes), with high-potassium diets or with potassium supplements, as this may lead to a severe potassium intoxication by increasing your blood potassium levels.
• If you have mild or moderate heart failure, as this medication may increase your blood potassium levels.
• If you are over 80 years old, your doctor will assess how well your kidneys are functioning.
• The concurrent administration of Aldactone with certain medications, potassium supplements, and high-potassium foods may cause severe hyperkalemia (elevated potassium levels in the blood). Symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.

During treatment with Aldactone, your doctor may perform regular blood tests to monitor your electrolyte levels and predict the risk of adverse effects. If you have severe heart failure, your doctor will closely monitor your potassium and creatinine levels in the blood.

Use of Aldactone 100 mg with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

There are some medications that may interact with Aldactone:

• Medications that may alter potassium levels in the blood (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, and potassium supplements).
• The concurrent administration of Aldactone with medications known to increase potassium levels in the blood may lead to a severe increase in potassium levels in the blood.
• Carbenoxolone (for the treatment of stomach or intestinal ulcers).
• Non-steroidal anti-inflammatory medications for pain and fever (e.g., aspirin, phenazone, indomethacin, and mefenamic acid).
• Medications that may alter the balance of electrolytes in the body (e.g., ammonium chloride, cholestyramine).
• Certain anti-inflammatory medications (corticosteroids).
• Other medications that lower blood pressure (anti-hypertensives).
• Alcohol, barbiturates, narcotics.
• Norepinephrine (noradrenaline), a medication used in emergency situations to raise blood pressure.
• Digoxin (a medication to regulate heart rhythm).
• Medications that decrease blood clotting (dicumarol).
• Lithium.
• Trimethoprim and trimethoprim/sulfamethoxazole.

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

Inform your doctor if you are using mitotane for the treatment of malignant tumors of the adrenal glands. This medication should not be used with mitotane.

Interference with diagnostic tests

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

Taking Aldactone 100 mg with food, drinks, and alcohol

Alcohol

Avoid drinking excessive amounts of alcohol while taking this medication, as it may potentiate the hypotensive effect of Aldactone.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

There is limited data on the use of Aldactone in pregnant women. Your doctor will only prescribe Aldactone if the potential benefits outweigh the potential risks.

Breastfeeding

Aldactone should not be used if you are breastfeeding your child. Discuss the use of Aldactone with your doctor, who will recommend an alternative method of feeding your baby while taking this medication.

Fertility

Women of childbearing age should take adequate contraceptive measures.

Use in athletes

This medication contains spironolactone, which may produce a positive result in doping control tests.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

In the case of heart failure, the usual initial dose is 25 mg per day. Your doctor may increase or decrease it as needed to reach the dose you need. The dose should not exceed 50 mg per day.

The maximum dose of Aldactone is 400 mg per day.

Use in children

In children, the dose can be administered as long as the child is able to swallow the tablets.

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

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

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

If you take more Aldactone 100 mg than you should

Aldactone overdose may cause drowsiness, mental confusion, low blood pressure, irregular heart rhythm, nausea, vomiting, diarrhea, skin rash, dehydration, and electrolyte imbalance.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication 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 the missed doses.

If you interrupt treatment with Aldactone 100 mg

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects are serious and if you experience one of them, you will need immediate action:

• In some cases, patients have presented alterations in blood electrolytes, and very rarely this has led to a potentially life-threatening situation (called hyperkalemia). If you have heart rhythm alterations, tingling sensation, muscle weakness, flaccid paralysis, or muscle spasms, stop taking Aldactone and inform your doctor immediately.

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

• Increased potassium in the blood (hyperkalemia)

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

• Confusion
• Dizziness, headaches, drowsiness
• Diarrhea, nausea
• Itching, skin rash, redness

• Leg cramps

• Acute kidney injury

• Excessive breast development in men (gynecomastia), menstrual irregularities (amenorrhea, postmenopausal bleeding), impotence, breast pain in men

• Discomfort, fatigue

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

• Benign tumors in the breast in men
• Blood electrolyte alterations, decreased sodium

• Tingling sensation (paresthesias)

• Liver function alterations
• Urticaria
• Elevated creatinine concentration in the blood
• Breast pain in women

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

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

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

• Benign tumors in the chest
• Changes in libido
• Coordination disorder (ataxia)
• Hair loss (alopecia), excessive hair growth (hypertrichosis)

Side effects of unknown frequency (cannot be estimated from available data):

• Gastrointestinal disorders
• Severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms)
• Pemphigoid (a disease that produces blisters filled with fluid on the skin).

Reporting side effects

If you experience any type ofside effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require any special storage conditions.

Do not use this medication after the expiration date (EXP) that appears on the packaging. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications.This will help protect the environment.

Composition of Aldactone 100 mg

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

The other components are: calcium dihydrate sulfate, cornstarch, polividone K-30, peppermint aroma, 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 packaging

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

Aldactone 100 mg is presented in blister packs containing 20 film-coated tablets and in clinical packs containing 500 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Responsible for manufacturing:

Farmasierra Manufacturing, S.L.

Carretera de Irún, Km. 26,200

28709 San Sebastián de los Reyes (Madrid).

Last review date of this leaflet: February 2025

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es