EPLERENONE VIR 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eplerenone Vir 50 mg film-coated tablets EFG

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Eplerenone Vir and what is it used for

Eplerenone Vir contains the active substance eplerenone.

Eplerenone belongs to a group of medicines known as selective aldosterone blockers. These blockers inhibit the action of aldosterone, a substance produced by the body that controls blood pressure and cardiac function. High levels of aldosterone can cause changes in your body that lead to heart failure.

Eplerenone is used to treat heart failure to prevent worsening and reduce hospitalization if you have:

1. a recent myocardial infarction, in combination with other medicines used to treat your heart failure or
2. mild persistent symptoms, despite the treatment you have been receiving so far.

2. What you need to know before you take Eplerenone Vir

Do not take Eplerenone Vir

• if you are allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6)
• if you have high levels of potassium in your blood (hyperkalemia).
• if you are taking medicines that help your body get rid of excess fluid (potassium-sparing diuretics)
• if you have severe kidney problems.
• if you have severe liver problems.
• if you are taking medicines used to treat fungal infections (ketoconazole or itraconazole).
• if you are taking antiviral medicines for the treatment of HIV (nelfinavir or ritonavir).
• if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin)
• if you are taking nefazodone for the treatment of depression.
• if you are taking medicines used to treat certain heart diseases or high blood pressure, such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARBs) at the same time.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Eplerenone Vir

• if you have kidney or liver disease (see also “Do not take Eplerenone Vir”)
• if you are taking lithium (used to treat manic-depressive illness, also known as bipolar disorder)
• if you are taking tacrolimus or cyclosporin (used to treat skin diseases such as psoriasis or eczema, and to prevent organ rejection in transplant patients).

Children and adolescents

The safety and efficacy of eplerenone in children and adolescents have not been established.

Other medicines and Eplerenone Vir

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines.

• Itraconazole or ketoconazole(used to treat fungal infections), ritonavir, nelfinavir(antiviral medicines for the treatment of HIV), clarithromycin, telithromycin(used to treat bacterial infections) or nefazodone(used to treat depression), as these medicines reduce the metabolism of eplerenone, and thus prolong its effect in the body.
• Potassium-sparing diuretics(medicines that help your body get rid of excess fluid) or potassium supplements(salt tablets), as these medicines increase the risk of high levels of potassium in your blood.
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARBs)at the same time (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medicines may increase the risk of high levels of potassium in the blood.

• Lithium(used to treat manic-depressive illness, also known as bipolar disorder). The use of lithium with diuretics and ACE inhibitors has been shown to cause high levels of lithium in the blood, which can cause the following side effects: loss of appetite; vision changes; fatigue; muscle weakness; muscle cramps.
• Cyclosporin or tacrolimus(used to treat skin diseases such as psoriasis or eczema, and to prevent organ rejection in transplant patients). These medicines can cause kidney problems and thus increase the risk of high levels of potassium in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs)(certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines can cause kidney problems and thus increase the risk of high levels of potassium in your blood.
• Trimethoprim(used to treat bacterial infections) may increase the risk of high levels of potassium in the blood.
• Alpha-1 blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate diseases), may cause a decrease in blood pressure and dizziness when standing up.
• Tricyclic antidepressants(such as amitriptyline or amoxapine) (for the treatment of depression), antipsychotics(also known as neuroleptics) (such as chlorpromazine or haloperidol) (for the treatment of psychiatric disorders), amifostine(used during cancer chemotherapy) and baclofen(used to treat muscle spasms). These medicines may cause a decrease in blood pressure and dizziness when standing up.
• Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin diseases) and tetracosactide(used primarily to diagnose and treat adrenal cortex diseases) may reduce the blood pressure-lowering effect of eplerenone.
• Digoxin(used in the treatment of heart diseases). Blood levels of digoxin may increase when taken with eplerenone.
• Warfarin(an anticoagulant medicine): caution is required when taking warfarin because high levels of warfarin in the blood may cause changes in the effect of eplerenone in the body.
• Erythromycin(used to treat bacterial infections), saquinavir(an antiviral medicine for the treatment of HIV), fluconazole(used to treat fungal infections), amiodarone, diltiazem, and verapamil(for the treatment of heart problems and high blood pressure) reduce the metabolism of eplerenone, thus prolonging its effect in the body.
• Hypericum perforatumor St. John's Wort(a herbal medicine), rifampicin(used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital(used, among other things, to treat epilepsy) may increase the metabolism of eplerenone and thus reduce its effect.

Taking Eplerenone Vir with food and drinks

Eplerenone can be taken with or without food.

Pregnancy and breast-feeding

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

The effect of eplerenone during pregnancy in humans has not been evaluated.

It is not known whether eplerenone is excreted in breast milk. Your doctor will decide with you whether to stop treatment or breast-feeding (see also “Do not take Eplerenone Vir”).

Driving and using machines

After taking eplerenone, you may feel dizzy. If this happens, do not drive or use machines.

Eplerenone Vir contains lactose

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Eplerenone Vir contains sodium

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

3. How to take Eplerenone Vir

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Eplerenone tablets can be taken with or without food. Swallow the tablets whole with plenty of water.

Eplerenone is usually given together with other medicines for heart failure, such as beta-blockers. The initial doseis usually one 25 mg tablet once a day, increasinglater after about 4 weeks to 50 mg daily(one 50 mg tablet or two 25 mg tablets). The maximum daily dose is 50 mg.

Potassium blood tests should be performed before starting treatment with eplerenone, during the first week, and one month after starting treatment or after a dose change. Your doctor may adjust the dose based on your potassium blood levels.

Kidney and liver problems

If you have mild kidney problems, you should start treatment with a 25 mg tablet per day. If you have moderate kidney problems, you should start treatment with a 25 mg tablet every other day. These doses may be adjusted if your doctor tells you to, and according to your potassium blood levels.

In patients with severe kidney disease, eplerenone is not recommended.

No initial dose adjustment is necessary in patients with mild to moderate liver problems. If you have any liver or kidney disease, you may need to have potassium blood tests more frequently (see also “Do not take Eplerenone Vir”).

Elderly patients

No initial dose adjustment is necessary.

Use in children and adolescents

Eplerenone is not recommended.

If you take more Eplerenone Vir than you should

If you take more eplerenone than you should, tell your doctor or pharmacist immediately. If you have taken too much medicine, the most likely symptoms will be low blood pressure (manifested as dizziness, blurred vision, weakness, sudden loss of consciousness) or hyperkalemia, high levels of potassium in the blood (manifested by muscle cramps, diarrhea, nausea, dizziness, or headache). You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Eplerenone Vir

If it is almost time for your next dose, skip the dose you missed and take the next dose at the right time.

Otherwise, take the dose as soon as you remember, provided that it is more than 12 hours until the time of your next dose. Then, take your medicine as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Eplerenone Vir

It is important to keep taking eplerenone as your doctor has told you, unless your doctor tells you to stop.

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.

If you experience any of the following side effects:

Seek medical attention immediately

• swelling of the face, tongue, or throat
• difficulty swallowing
• blisters and difficulty breathing

These are symptoms of angioedema, a rare side effect (may affect up to 1 in 100 people).

Other side effects reported include:

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

• high levels of potassium in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• fainting
• dizziness
• high levels of cholesterol in the blood
• insomnia (difficulty sleeping)
• headache
• heart problems (such as irregular heartbeats and heart failure)
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasms
• increased levels of urea in the blood
• increased levels of creatinine in the blood, which may indicate kidney problems.

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

• infection
• eosinophilia (an increase in certain white blood cells)
• dehydration
• high levels of triglycerides (fats) in the blood
• low levels of sodium in the blood
• rapid heartbeat
• inflammation of the gallbladder
• low blood pressure that may cause dizziness when standing up
• blood clots in the legs
• sore throat
• flatulence
• hypothyroidism
• increased blood sugar levels
• decreased sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men.
• changes in certain blood tests

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 to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Vir

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Eplerenona Vir Composition

• The active ingredient is eplerenone. Each tablet contains 50 mg of eplerenone.
• The other components are lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), sodium lauryl sulfate, talc (E553b), and magnesium stearate (tablet core); hypromellose (E464), polysorbate 80 (E433), macrogol 400, titanium dioxide (E171), and yellow iron oxide (E172) (tablet coating).

Product Appearance and Packaging Contents:

50 mg tablet: film-coated yellow tablet, round, biconvex, marked with "E9RN" on one side and "50" on the other.

Eplerenona Vir is available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, or 100 tablets; single-dose blister packs of 10 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, or 100 x 1 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna, 6-68-70 Pol. Industrial Urtinsa II

28923 Alcorcón, Madrid

Spain

Manufacturer

SYNTHON HISPANIA, S.L

Castello 1, Polígono Las Salinas.

Sant Boi de Llobregat (Barcelona)

08830-Spain

or

SYNTHON BV

Microweg, 22, P.O.Box

7071Nijmegen-NL-6545Netherlands

or

ELPEN PHARMACEUTICAL CO INC.

95 Marathonos Avenue- Pikermi.

Attica. Greece

or

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

Laguna, 66-68-70. Polígono Industrial Urtinsa

II. Alcorcón (Madrid) Spain

or

Betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this prospectus:August 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/)