Spironolactone Alter 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Espironolactone Alter 100 mg film-coated tablets

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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Espironolactone Alter 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.

Spironolactone is used to reduce high blood pressure (hypertension), swelling due to fluid accumulation (edema) 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 conditions caused by abnormally high production of a natural hormone (aldosterone).

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

2. What you need to know before taking Espironolactone Alter 100 mg

Children with severe renal impairment must not take spironolactone.

Do not take Espironolactone Alter

• If you are allergic to spironolactone or to 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 renal failure, severely impaired renal 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 causes damage to the adrenal cortex, resulting in hormonal deficiency.
• If you are being treated with eplerenone (a medicine used to help prevent worsening heart failure after a myocardial infarction).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Espironolactone Alter 100 mg.

• If you have severe liver problems, including hepatic cirrhosis.
• If you are diabetic.
• If you have kidney or liver problems, severe heart failure, or if you are elderly, the use of spironolactone may alter your blood levels of certain electrolytes, and 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, ACE inhibitors, angiotensin II antagonists, aldosterone blockers) or with medicines to prevent blood clotting (heparins), since concomitant use of these medicines with Espironolactone Alter may lead to increased potassium levels in the 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 treatment of high blood pressure and other heart conditions), since concomitant use of Espironolactone Alter with these medicines may increase your blood potassium levels.
• The use of spironolactone together with salt substitutes (potassium-containing salt replacements), potassium-rich diets, or potassium supplements is not recommended, as this may lead to severe intoxication due to increased blood potassium levels.
• If you have mild or moderate heart failure, since 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 Espironolactone Alter 100 mg with certain medicines, potassium supplements, and potassium-rich foods may cause severe hyperkalemia (increased potassium levels in blood). Symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.

During treatment with Espironolactone Alter, your doctor may periodically perform tests to monitor your blood electrolyte levels and thus predict the risk of adverse effects. If you have severe heart failure, your doctor will especially monitor your blood potassium and creatinine levels.

Taking Espironolactone Alter 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 Espironolactone Alter 100 mg:

• Medicines that may alter potassium levels in blood (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, and potassium supplements).
• Concomitant administration of spironolactone with medicines known to increase blood potassium levels may lead to a serious increase in blood potassium levels.
• Non-steroidal anti-inflammatory drugs for pain and fever (e.g., acetylsalicylic acid, phenazone, indomethacin, mefenamic acid).
• Carbenoxolone (used to treat stomach or intestinal ulcers).
• 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 capacity (dicoumarols).
• 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 taking mitotane for the treatment of malignant adrenal gland tumors. This medicine must not be used together with mitotane.

Interference with diagnostic tests

Espironolactone Alter 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 Espironolactone Alter, as it may alter the results.

Taking Espironolactone Alter 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 Espironolactone Alter.

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

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

Breastfeeding

Do not take Espironolactone Alter if you are breastfeeding.

Fertility

Women of childbearing age should use appropriate contraceptive measures.

Use in athletes

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

Driving and using machines

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

Espironolactone Alter contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Espironolactone Alter contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Espironolactone Alter 100 mg

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

The recommended starting dose of spironolactone for 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, possibly increasing it up to 200 mg daily.

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

The maximum dose of spironolactone is 400 mg daily.

Use in children

Spironolactone may be administered to children only if the child is able to swallow the tablets.

Spironolactone 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 this medicine.

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

If you take more Espironolactone Alter than you should

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

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 Espironolactone 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 Espironolactone Alter

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

4. Possible adverse effects

Like all medicines, Espironolactona Alter can produce adverse effects, although not everyone experiences them.

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

• Occasionally, patients have experienced disturbances in blood electrolytes, and very rarely this has led to a serious, potentially life-threatening condition (called hyperkalemia). If you experience irregular heartbeat, tingling sensation, muscle weakness, flaccid paralysis, or muscle spasms, stop taking Espironolactona Alter and contact your doctor immediately.

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

• Increased potassium in the blood (hyperkalemia)

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

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

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

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

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

• Acute kidney failure
• Agranulocytosis (reduced number of neutrophils in blood), leukopenia (reduced number of white blood cells), thrombocytopenia (reduced number of platelets)
• Liver function disturbances

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

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

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

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

Reporting of adverse effects:

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

5. Storage of Spironolactone 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 Spironolactone Alter after the expiry date stated on the packaging after the abbreviation EXP. 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 containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

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

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

Nature of the product and pack contents

The film-coated tablets are white, biconvex 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 most recent review of this leaflet: February 2025

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