ESPIRONOLACTONA ACCORD 100 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Espironolactona Accord 100mg film-coated tablets EFG

espironolactone

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

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

Contents of the leaflet:

1. What is Espironolactona Accord and what is it used for
2. What you need to know before taking Espironolactona Accord
3. How to take Espironolactona Accord
4. Possible side effects
   1. Storage of Espironolactona Accord

1. Contents of the pack and further information

1. What is Espironolactona Accord and what is it used for

The active substance of the tablets is spironolactone. Spironolactone belongs to a specific group of medicines, known as aldosterone antagonists, which inhibit the action of the aldosterone hormone. One of the functions of aldosterone is to ensure that the body retains sodium. It is part of a system that regulates the balance of fluids and salts in the body (renin-angiotensin-aldosterone system, "RAAS"). Spironolactone promotes the excretion of urine in patients with fluid accumulation in the tissues (edema) or in the abdominal cavity (ascites) by increasing the sodium (salt) excreted in the urine. The loss of potassium is reduced as a possible consequence of the use of certain diuretics. The antihypertensive effect depends on the excretion of water and salt.

Your doctor may prescribe Espironolactona Accord for the treatment of:

• fluid accumulation in the tissues as a result of heart disorders;
• severe heart failure (NYHA functional classes III-IV);
• high blood pressure as a complement to a salt-free diet and diuretics;
• certain kidney disorders;
• fluid accumulation in the tissues of the abdominal cavity.

Espironolactona Accord can also be used:

during medical examinations (diagnostics) to confirm the presence of disorders in which there is an excessively high level of aldosterone in the adrenal cortex (known as Conn's disease) and its treatment.

Children should only receive treatment with the guidance of a pediatrician.

2. What you need to know before taking Espironolactona Accord

Do not take Espironolactona Accord

• If you are allergic to spironolactone or any of the other components of this medicine (listed in section 6).
• If you have severe kidney failure or sudden or rapidly worsening kidney disease, including cases where no urine is produced or very little is produced.
• If you have low sodium levels (hyponatremia).
• if you have Addison's disease (a hormonal deficiency characterized by extreme weakness, weight loss, and low blood pressure)
• If you have hyperkalemia (elevated potassium levels in the blood) or any other disease associated with hyperkalemia.
• If you are taking potassium-sparing diuretics (including eplerenone) or potassium supplements, or dual blockade of RAAS with the combination of an angiotensin-converting enzyme inhibitor (ACE) and an angiotensin receptor antagonist (ARA).

Children with moderate to severe kidney disease should not take Espironolactona Accord.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Espironolactona Accord.

• Patient's on spironolactone therapy require regular monitoring with control of fluid and electrolyte status, especially in the elderly and/or in patients with pre-existing renal or hepatic impairment.
• If you have difficulty urinating.
• If you have a liver disorder, your doctor should exercise caution when treating you.
• If you have a kidney disorder, your doctor should exercise caution when treating you.
• If you have high potassium levels in the blood or kidney function impairment, it is not recommended to administer Espironolactona Accord (see also "Do not take Espironolactona Accord").
• If you have severe kidney impairment being treated simultaneously with potassium supplements, as hyperkalemia may occur, which can lead to cardiac arrest (sometimes fatal).
• In the case of long-term treatment of young patients with Espironolactona Accord, your doctor should carefully weigh the benefits against the long-term disadvantages.
• If you have a disease that can alter the electrolyte balance (minerals in the blood such as potassium and sodium) in the blood.
• If you have an increase or decrease in electrolytes in the blood, such as potassium or sodium
• If you have severe heart failure
• If you are taking another diuretic in combination with Espironolactona Accord that may cause low sodium levels (hyponatremia) in the blood.
• The concomitant administration of Espironolactona Accord with certain medications, potassium supplements, and potassium-rich foods could cause severe hyperkalemia (elevated potassium levels in the blood). Symptoms of severe hyperkalemia can produce muscle cramps, arrhythmias, diarrhea, nausea, dizziness, or headache.

Inform your doctor if any of the above warnings apply to your current or past situation.

Children

Spironolactone should be used with caution in children with arterial hypertension and mild kidney disease. Your doctor will evaluate them on a routine basis. (Children with moderate to severe kidney disease should not take spironolactone).

Other medicines and Espironolactona Accord

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription. Your doctor may want to change your dose of Espironolactona Accord if you are taking any of the following:

• medicines for hypertension, including ACE inhibitors and ganglion-blocking drugs
• other diuretics
• non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (aspirin), ibuprofen, or mefenamic acid
• potassium supplements
• heparin or low molecular weight heparin (medicines used to prevent blood clot formation)
• medicines that inhibit blood coagulation (anticoagulants),
• lithium (used to treat depression)
• digoxin (used in the treatment of various heart diseases)
• alcohol, barbiturates, or opioids
• medicines known to cause hyperkalemia (elevated potassium levels in the blood)
• cholestyramine (used to reduce cholesterol levels in the blood)
• corticosteroids, ACTH (prescribed for various epileptic conditions)
• ammonium chloride (e.g., in licorice)
• cyclosporine
• carbenoxolone, used for the treatment of gastroesophageal reflux disease
• noradrenaline, used for the treatment of acute hypotension
• cardiac glycosides, used in the treatment of heart failure
• medicines for local or general anesthesia
• trimethoprim and trimethoprim-sulfamethoxazole

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

If you are going to undergo surgery in which you will be administered anesthesia, inform the responsible doctor that you are taking spironolactone.

Espironolactona Accord with food

This medicine should be taken with food.

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.

Spironolactone should not be used during pregnancy unless your doctor considers it necessary.

Spironolactone should not be used during breastfeeding. You should discuss the use of spironolactone with your doctor, who will advise you to consider an alternative method for feeding your baby while taking this medicine.

Spironolactone may impair fertility and induce impotence and menstrual irregularities.

Driving and using machines

Occasional side effects such as dizziness, headache, and confusion may occur while taking Espironolactona Accord. In this case, do not drive a vehicle or use machines.

Espironolactona Accord contains lactose

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

3. How to take Espironolactona Accord

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

The recommended dose is:

Adults

The recommended dose is 100 mg per day, administered in one or several doses. The dose for adults ranges from 25 mg to 400 mg of spironolactone per day. If you are unsure of the amount you should take, consult your doctor or pharmacist.

You should take the tablets with meals. If the total dose is more than 100 mg per day, it should be administered in several doses throughout the day.

Use in children

The recommended dose is 3 mg per kilogram of body weight per day, divided into several doses. The tablets can be crushed or ground and then suspended in a glass of water to facilitate administration to children.

Elderly patients

It is recommended that elderly patients start with the lowest possible dose and gradually increase it until the desired effect is achieved. Caution and regular medical check-ups are recommended, especially in case of kidney failure.

Do not forget to take your medication. Try to take the tablets at the same time of day to achieve the best effect. This will also help you remember when to take the tablets.

If you take more Espironolactona Accord than you should

If you have ingested too much Espironolactona Accord, contact your doctor or pharmacist immediately. Keep the package so that the doctor can see what medicine you have taken.

Symptoms of overdose may be nausea and vomiting and (less frequently) drowsiness, confusion, diarrhea, or skin rash that appears as flat red patches on the skin with small elevated bumps superimposed. Fluid and salt imbalance and dehydration may occur.

Changes in sodium and potassium levels in the blood can cause you to feel weak and experience tingling, pricking, or numbness of the skin and/or muscle spasms, but it is unlikely that these symptoms will be associated with severe overdose.

If you forget to take Espironolactona Accord

If you have forgotten to take a dose, take it as soon as possible unless it is almost time to take the next dose, in which case you should not take the missed dose, but continue according to the prescribed schedule. Do not take a double dose to make up for missed doses. Ask your doctor or pharmacist if you are unsure.

If you stop taking Espironolactona Accord

If you stop taking Espironolactona Accord, the initial symptoms may return. Always consult your doctor if you want to stop treatment with the medicine.

If you have any other doubts about 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 everyone gets them.

Tell your doctor immediatelyif you experience any of the following symptoms after taking this medicine. Although they are very rare, the symptoms can be serious.

• itching and blistering of the skin around the lips and on the rest of the body,
• red or purple rash that spreads and forms blisters (Stevens-Johnson syndrome)
• shedding of the top layer of the skin from the underlying layers, all over the body (toxic epidermal necrolysis - TEN)
• skin rash, fever, and swelling (which could be symptoms of something more serious, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• yellowing of the skin and eyes (jaundice; spironolactone may cause liver function disorders)
• irregular heartbeat that can be fatal, sensation of tingling, paralysis (loss of muscle function), or difficulty breathing; which can be symptoms of high potassium levels in your blood.

Your doctor will perform periodic blood tests to monitor potassium and other electrolyte levels. Your doctor may interrupt treatment if necessary.

Other side effects

Very common: may affect more than 1 in 10 people

• Increased potassium in the blood

Common: may affect up to 1 in 10 people

• confusion
• dizziness
• discomfort
• itching of the skin
• skin rash
• muscle cramps or leg cramps
• kidney failure or abnormal function
• breast enlargement in men
• breast pain (in men)
• general discomfort

Uncommon: may affect up to 1 in 100 people

• breast disorders, such as lumps
• electrolyte disturbances, such as hypercalcemia
• abnormal liver function
• skin allergy with itching and hives, urticaria-like rash
• menstrual problems in women
• chest pain (in women)

Frequency not known: cannot be estimated from available data

• decrease in the number of white blood cells in the blood
• decrease in the number of cells that fight infections (white blood cells that increase the likelihood of infections)
• decrease in the number of cells that carry oxygen (anemia)
• decrease in the number of cells that help blood clot or increase in the number of eosinophils in the blood (eosinophilia) that increases the risk of bleeding or bruising or causes purple spots on the skin (purpura)
• change in sexual desire in both men and women
• temporary impotence in men
• digestive problems, gastrointestinal discomfort
• skin condition with fluid-filled blisters (pemphigoid)
• hair loss
• excessive hair growth
• headache
• drowsiness
• general weakness or lethargy and coordination problems (ataxia)
• fever

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them 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 Espironolactona Accord

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special storage temperature. Store in the original packaging to protect it from light.
• Do not use this medicine after the expiration date stated on the packaging, after EXP. The expiration date is the last day of the month indicated.
• Medicines should not be disposed of through wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Espironolactona Accord

The active ingredient is spironolactone. Espironolactona Accord contains 100 mg of spironolactone.

The other components are:

Core of the tablet

Lactose monohydrate, pregelatinized corn starch, anhydrous calcium hydrogen phosphate, povidone K25, peppermint oil, purified talc, anhydrous colloidal silica, magnesium stearate (E470b).

Film coating

Hypromellose, macrogol, titanium dioxide (E171)

Appearance of the Product and Container Content

Espironolactona Accord 100 mg film-coated tablets consist of round, biconvex tablets of white or pale white color, which are printed with "AF" on one side and no mark on the other. The diameter of the 100 mg tablet is approximately 11.2 mm.

The tablets of Espironolactona Accord are packaged in PVC-aluminum blisters or HDPE bottles.

Container sizes:

Blister pack: 20, 28, 30, 50, 60, 90 or 100 tablets in blister.

HDPE bottle: 250, 500 and 1000 tablets (for hospital use or dose dispenser only).

Only some container sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Est Building, 6th floor

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,

95-200 Pabianice

Poland

Or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Or

Accord Healthcare Single Member S.A.,

64th Km National Road Athens Lamia,

Schimatari, 32009, Greece

Date of the Last Revision of this Leaflet: April 2025

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