ALDACTONE 100 mg FILM-COATED TABLETS

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

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 medicine or any of the other ingredients of this medicine (listed in section 6).
• If you have certain kidney function disorders (acute kidney failure, severely altered kidney function, lack of urine arrival in the bladder, or anuria).
• If you have high levels of potassium in the blood.
• If you suffer from a disease called Addison's disease, which damages the adrenal cortex and leads to a hormonal deficiency.
• If you are being treated with eplerenone (a medicine 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 liver 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 periodic checks.
• If you are being treated with other medicines used for high blood pressure or heart failure (potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, or aldosterone blockers) or with medicines to prevent blood clotting (heparins), as the combined use of these medicines with Aldactone may lead to an increase in potassium levels in the blood, which can cause serious problems.
• If you are being treated with non-steroidal anti-inflammatory medicines (for pain and inflammation) or beta-blockers (for high blood pressure and other heart problems), as the combined use of Aldactone with these medicines may lead to an increase in potassium levels in the blood.
• It is not recommended to use spironolactone with salt substitutes (potassium-containing salt substitutes), potassium-rich diets, or potassium supplements, as this can lead to severe poisoning by increasing potassium levels in the blood.
• If you have mild or moderate heart failure, as this medicine may increase your potassium levels in the blood.
• If you are over 80 years old, your doctor will assess your kidney function.
• The concomitant administration of Aldactone with certain medicines, potassium supplements, and potassium-rich foods may cause severe hyperkalemia (increased potassium levels in the blood). The symptoms of severe hyperkalemia could include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.

During treatment with Aldactone, your doctor may perform periodic tests to check your blood electrolyte levels and predict the risk of side 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 medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

There are some medicines that may interact with Aldactone:

• Medicines that may alter potassium levels in the blood (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, and potassium supplements).
• The concomitant administration of Aldactone with medicines known to increase potassium levels in the blood may lead to a serious increase in potassium levels in the blood.
• Carbenoxolone (for the treatment of stomach or intestinal ulcers).
• Non-steroidal anti-inflammatory medicines for pain and fever (e.g., aspirin, phenazone, indomethacin, and mefenamic acid).
• Medicines that may alter the balance of electrolytes in the body (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 decrease blood clotting (dicumarolics).
• Lithium.
• Trimethoprim and trimethoprim/sulfamethoxazole.

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

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

Interference with diagnostic tests

Aldactone may interfere with the results of some diagnostic tests. If you are to undergo any diagnostic test to assess digoxin levels, tell 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 too much 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

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

Fertility

Women of childbearing age should take adequate contraceptive measures.

Use in athletes

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

Driving and using machines

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

3. How to take Aldactone 100 mg

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended initial dose of Aldactone for the treatment of arterial hypertension 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 if necessary until you 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 may 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 at the same time every day.

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

An overdose of Aldactone may cause drowsiness, mental confusion, low blood pressure, alteration of heart rhythm, nausea, vomiting, diarrhea, skin rash, dehydration, and alteration of electrolytes.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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 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.

The following side effects are important and if you experience one of them, you will need to take 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 experience alterations in heart rhythm, 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 levels in the blood (hyperkalemia)

Common side 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 irregularities (irregularities, amenorrhea, post-menopausal bleeding), impotence, breast pain in men

• Discomfort, fatigue

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

• Benign breast tumors in men
• Alterations in blood electrolytes, decreased sodium

• Tingling sensation (paresthesia)

• Liver function disorders
• Hives
• Elevated creatinine levels in the blood
• Breast pain in women

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

• Decreased neutrophil count in the blood (agranulocytosis), decreased white blood cell count in the blood (leukopenia), decreased platelet count in the blood (thrombocytopenia)
• Acute kidney failure

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

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

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side 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 does not require any special storage conditions.

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

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Contents of the pack and further information

Composition of Aldactone 100 mg

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

The other ingredients are: calcium sulfate dihydrate, cornstarch, povidone K-30, peppermint flavor, and magnesium stearate.

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

Appearance of the product and pack contents

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

Aldactone 100 mg is available in packs with blisters containing 20 film-coated tablets and in clinical 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 last revision of this leaflet: February 2025

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