SPIRONOLACTONE ALTER 100 mg FILM-COATED TABLETS

2. What you need to know before you take Espironolactona Alter 100 mg

Children with severe kidney failure should not take spironolactone.

Do not take Espironolactona Alter

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Espironolactona Alter 100 mg.

• If you have severe liver problems, including liver cirrhosis.
• If you are diabetic.
• If you have kidney, liver, or severe heart failure problems, or if you are an elderly patient, the use of spironolactone may alter your blood levels of certain electrolytes, so your doctor will perform periodic checks.
• If you are taking other medications used to treat high blood pressure or heart failure (potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, or blood thinners) or medications to prevent blood clotting (heparins), as the combined use of these medications with Espironolactona Alter may lead to an increase in potassium levels in the blood, which can cause serious problems.
• If you are taking non-steroidal anti-inflammatory medications (for pain and inflammation) or beta-blockers (for high blood pressure and other heart problems), as the combined use of Espironolactona Alter with these medications 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 potassium intoxication.
• 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 Espironolactona Alter 100 mg with certain medications, potassium supplements, and potassium-rich 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 Espironolactona Alter, 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.

Taking Espironolactona Alter 100 mg with other medicines

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

There are some medicines that may interact with Espironolactona Alter 100 mg:

• Medicines that may alter potassium levels in the blood (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, and potassium supplements).
• The combined administration of spironolactone with medications known to increase potassium levels in the blood may lead to a serious increase in potassium levels in the blood.
• Non-steroidal anti-inflammatory medications for pain and fever (e.g., acetylsalicylic acid, phenazone, indomethacin, mefenamic acid).
• Carbenoxolone (for the treatment of stomach or intestinal ulcers).
• Medicines 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 (antihypertensives).
• Alcohol, barbiturates, narcotics.
• Norepinephrine (noradrenaline), a medication used in emergency situations to raise blood pressure.
• Digoxin (a medication to regulate heart rhythm).
• Medicines that reduce 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

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

Taking Espironolactona Alter 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 Espironolactona Alter.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Espironolactona Alter if you are pregnant, think you may be pregnant, or are trying to become pregnant.

Breastfeeding

Do not take Espironolactona Alter if you are breastfeeding.

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

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

Espironolactona Alter contains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

Espironolactona Alter contains sodium.This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Espironolactona Alter 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 starting dose of spironolactone 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, up to a maximum dose of 50 mg per day.

The maximum dose of spironolactone 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.

The tablets of spironolactone 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 this medicine.

Ask your doctor if you think the effect of spironolactone is too strong or too weak.

If you take more Espironolactona Alter than you should

An overdose of spironolactone can cause drowsiness, mental confusion, low blood pressure, irregular heartbeat, nausea, vomiting, diarrhea, skin rash, dehydration, and electrolyte disturbances.

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 Espironolactona Alter

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 Espironolactona Alter

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

4. Possible side effects

Like all medicines, Espironolactona Alter 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 with alterations in blood electrolytes, and very rarely this has led to a potentially life-threatening situation (called hyperkalemia). If you experience irregular heartbeat, tingling sensation, muscle weakness, flaccid paralysis, or muscle spasms, stop taking Espironolactona Alter and consult 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.
• Discomfort, fatigue, dizziness, headache, drowsiness.
• Itching, skin rash, redness.
• Excessive breast development in men (gynecomastia), menstrual irregularities (irregularities, amenorrhea, post-menopausal bleeding), impotence, breast pain in men.
• Diarrhea, nausea.
• Acute kidney injury.

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

• Benign breast tumors in men.
• Itching.
• Electrolyte disturbances in the blood (decreased sodium levels).
• 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):

• Acute kidney failure.
• Agranulocytosis (decreased neutrophil count in the blood), leukopenia (decreased white blood cell count in the blood), thrombocytopenia (decreased platelet count in the blood).
• Liver function disorders.

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

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

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

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Espironolactona Alter 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 Espironolactona Alter after the expiration date stated on the packaging after the abbreviation EXP. The expiration 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. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

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

The other ingredients (excipients) are: lactose, sodium carboxymethyl starch, magnesium stearate, hypromellose (E464), povidone, titanium dioxide (E171), and hydroxypropyl cellulose.

Appearance of the product and packaging contents

The film-coated tablets are white, lenticular, and scored on one side.

They are available in packs of 20 and 30 film-coated tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

or

Laboratorios Alter, S.A.

C/ Zeus 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Date of the last revision of this leaflet:February 2025

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