Spironolactone Accord 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Espironolactone Accord 100 mg film-coated tablets EFG

spironolactone

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of this leaflet:

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

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

The active substance in the tablets is spironolactone. Spironolactone belongs to a specific group of medicines known as aldosterone antagonists, which block the action of the hormone aldosterone. 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 urine excretion in patients who have fluid accumulation in the tissues (edema) or in the abdominal cavity (ascites), by increasing the amount of sodium (salt) excreted in the urine. It reduces potassium loss, which may otherwise occur as a consequence of using certain diuretics. The antihypertensive effect depends on the excretion of water and salt.

Your doctor may prescribe Espironolactone Accord for the treatment of:

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

Espironolactone Accord may also be used:

during medical examinations (diagnostics) to confirm the presence of disorders involving excessively high levels of aldosterone produced in the adrenal cortex (known as Conn's syndrome), and for its treatment.

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

2. What you need to know before starting to take Spironolactone Accord

Do not take Spironolactone Accord

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

Children with moderate to severe kidney disease must not take Spironolactone Accord.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Spironolactone Accord.

• Patients receiving spironolactone require regular monitoring of fluid and electrolyte status, especially in elderly patients and/or those with pre-existing impaired renal or hepatic function.
• 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 impaired kidney function, administration of Spironolactone Accord is not recommended (see also "Do not take Spironolactone Accord").
• If you have severe renal dysfunction and are simultaneously being treated with potassium supplements, hyperkalemia may occur, which could lead to cardiac arrest (sometimes fatal).
• In cases of long-term treatment of young patients with Spironolactone Accord, your doctor should carefully weigh the benefits against the potential long-term risks.
• If you have a disease that may alter the electrolyte balance (blood minerals such as potassium and sodium).
• If you have any increase or decrease in blood electrolytes, such as potassium or sodium.
• If you have severe heart failure.
• If you are taking another diuretic in combination with Spironolactone Accord that may cause low sodium levels (hyponatremia) in the blood.
• Concomitant use of Spironolactone Accord with certain medications, potassium supplements, and potassium-rich foods may lead to severe hyperkalemia (increased potassium levels in the blood). Symptoms of severe hyperkalemia may include muscle cramps, arrhythmias, diarrhea, nausea, dizziness, or headache.

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

Children

Spironolactone should be used with caution in children with hypertension and mild kidney disease. Your doctor will routinely monitor them. (Children with moderate to severe kidney disease must not take spironolactone.)

Other medicines and Spironolactone Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Your doctor may need to adjust your dose of Spironolactone Accord if you are taking any of the following:

• Medications for high blood pressure, including ACE inhibitors and ganglionic blocking agents.
• 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 clots).
• Drugs that inhibit blood clotting (anticoagulants).
• Lithium (used to treat depression).
• Digoxin (used in the treatment of various heart conditions).
• Alcohol, barbiturates, or opioids.
• Medicines known to cause hyperkalemia (high potassium levels in the blood).
• Cholestyramine (used to lower blood cholesterol levels).
• Corticosteroids, ACTH (prescribed for various epileptic conditions).
• Ammonium chloride (e.g., in licorice).
• Cyclosporine.
• Carbenoxolone, used to treat gastroesophageal reflux disease.
• Norepinephrine, used to treat acute hypotension.
• Cardiac glycosides, used in the treatment of heart failure.
• Medications for local or general anesthesia.
• Trimethoprim and trimethoprim-sulfamethoxazole.
• 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.

If you are undergoing surgery where you will receive anesthesia, inform the responsible physician that you are taking spironolactone.

Spironolactone Accord with food

This medicine should be taken with food.

Pregnancy, breastfeeding, and fertility

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

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

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

Spironolactone may impair fertility and cause impotence and menstrual irregularities.

Driving and using machines

Occasionally, side effects such as dizziness, headache, and confusion may occur while taking Spironolactone Accord. In such cases, do not drive or operate machinery.

Spironolactone Accord contains lactose

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

3. How to take Spironolactone Accord

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults

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

You should take the tablets with food. If the total daily dose exceeds 100 mg, it should be administered in several divided doses throughout the day.

Use in children

The recommended dose is 3 mg per kg of body weight per day, divided into several doses. The tablets may 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 advised, especially in cases of renal impairment.

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

If you take more Spironolactone Accord than you should

If you have taken too much Spironolactone Accord, contact your doctor or pharmacist immediately. Keep the packaging so the doctor can see which medicine you have taken.

Symptoms of overdose may include nausea and vomiting, and (less frequently) drowsiness, confusion, diarrhoea, or a skin rash appearing as flat red areas of skin with small raised bumps. Disturbances in fluid and electrolyte balance and dehydration may occur.

Changes in blood levels of sodium and potassium may cause weakness and tingling, pricking or numbness of the skin and/or muscle spasms, but these symptoms are unlikely to be associated with severe overdose.

If you forget to take Spironolactone Accord

If you forget to take a dose, take it as soon as possible unless it is almost time for your next dose. In that case, do not take the missed dose but continue with your regular schedule. Do not take a double dose to make up for forgotten doses. Ask your doctor or pharmacist if you are not sure.

If you stop taking Spironolactone Accord

If you stop treatment with Spironolactone Accord, your initial symptoms may return. Always consult your doctor if you wish to discontinue treatment with this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms may be serious.

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

Your doctor will carry out periodic blood tests to monitor your potassium and other electrolyte levels. Your doctor may stop treatment if necessary.

Other adverse 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
• skin itching
• skin rash
• muscle or leg cramps
• kidney failure or abnormal kidney function
• breast enlargement in men
• breast pain (in men)
• general malaise

Uncommon: may affect up to 1 in 100 people

• changes in breast glands, such as lumps
• disturbances in body electrolytes, such as hypercalcemia
• abnormal liver function
• skin allergy with itching and hives, rash resembling nettle 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 cells that fight infections (white blood cells, increasing the likelihood of infections)
• decrease in cells that carry oxygen (anaemia)
• decrease in cells that help blood clotting or increase in eosinophils in the blood (eosinophilia), increasing the risk of bleeding or bruising or causing 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 (bullous pemphigoid)
• hair loss
• excessive hair growth
• headache
• drowsiness
• general weakness or lethargy and problems with muscular coordination (ataxia)
• • fever

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if these are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Spironolactone 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 expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Spironolactone Accord

The active substance is spironolactone. Spironolactone Accord contains 100 mg of spironolactone.

The other components are:

Tablet core

Monohydrate lactose, pregelatinized maize 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 medicine and contents of the pack

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

Spironolactone Accord tablets are packed in PVC-aluminum blisters or in HDPE bottles.

Pack sizes:

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 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,

The Netherlands

Or

Accord Healthcare Single Member S.A.,

64th Km National Road Athens Lamia,

Schimatari, 32009, Greece

Date of the most recent revision of this leaflet: April 2025

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