Eplerenone Vir 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eplerenone Vir 50 mg film-coated tablets EFG

Read the entire 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Eplerenone Vir is and what it is 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 regulates blood pressure and heart function. Elevated levels of aldosterone can cause changes in the body that may lead to heart failure.

Eplerenone is used to treat heart failure to prevent worsening of the condition and reduce hospitalization in patients who have:

1. recently had a myocardial infarction, in combination with other medicines used to treat their heart failure, or
2. persistent mild symptoms, despite ongoing treatment received up to now.

2. What you need to know before taking Eplerenone Vir

Do not take Eplerenone Vir

• if you are allergic to eplerenone or to any of the other ingredients of this medicine (listed in section 6)
• if you have high levels of potassium in your blood (hyperkalaemia)
• if you are taking medicines from groups that help your body eliminate excess fluid (potassium-sparing diuretics)
• if you have severe renal impairment
• if you have severe hepatic impairment
• if you are taking antifungal medicines used to treat fungal infections (ketoconazole or itraconazol)
• 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 simultaneously taking medicines used to treat certain heart conditions or hypertension, such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARBs)

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 (commonly used for manic-depressive disorder, also known as bipolar disorder)
• if you are taking tacrolimus or cyclosporine (used to treat skin conditions such as psoriasis or eczema, and to prevent rejection of transplanted organs)

Children and adolescents

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

Other medicines and Eplerenone Vir

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for treating HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the metabolism of eplerenone, thereby prolonging its effect in the body.
• Potassium-sparing diuretics (medicines that help eliminate excess fluid from the body) or potassium supplements (salt tablets), as these medicines increase the risk of developing high potassium levels in your blood.
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARBs) taken together (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medicines may increase the risk of high potassium levels in the blood.
• Lithium (commonly used for manic-depressive disorder, also known as bipolar disorder). The use of lithium together with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) has been shown to cause excessively high levels of lithium in the blood, which may lead to the following adverse effects: loss of appetite; vision disturbances; fatigue; muscle weakness; muscle cramps.
• Cyclosporine or tacrolimus (used to treat skin conditions such as psoriasis or eczema, and to prevent rejection of transplanted organs). These medicines may cause kidney problems and thus increase the risk of developing high potassium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines may cause kidney problems and thus increase the risk of high potassium levels in the blood.
• Trimethoprim (used to treat bacterial infections) may increase the risk of high potassium levels in the blood.
• Alpha-1 blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions), may lead to a drop in blood pressure and dizziness upon standing.
• 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 lead to a drop in blood pressure and dizziness upon standing.
• Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions), and tetracosactide (used mainly to diagnose and treat adrenal cortex disorders) may reduce the blood pressure-lowering effect of eplerenone.
• Digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with eplerenone.
• Warfarin (an anticoagulant medicine): Caution is required when taking warfarin, as high levels of warfarin in the blood may affect how eplerenone acts 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 (used to treat heart problems and high blood pressure) reduce the metabolism of eplerenone, thereby prolonging its effect in the body.
• Hypericum perforatum or St. John’s Wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy) may increase the metabolism of eplerenone and thereby reduce its effect.

Taking Eplerenone Vir with food and drink

Eplerenone may be taken with or without food.

Pregnancy and breastfeeding

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

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

It is unknown whether eplerenone is excreted in breast milk. Your doctor will decide with you whether to discontinue treatment or breastfeeding.

Driving and use of machines

You may feel dizzy after taking eplerenone. If this occurs, do not drive or operate machinery.

Eplerenone Vir contains lactose

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

Eplerenone Vir contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet and is therefore considered essentially “sodium-free”.

3. How to take Eplerenona Vir

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

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

Eplerenone is usually administered together with other medicines for heart failure, for example, beta-blockers. The usual starting dose is one 25 mg tablet once daily, which is then increased after approximately 4 weeks to 50 mg daily (one 50 mg tablet or two 25 mg tablets). The maximum daily dose is 50 mg.

Blood potassium levels should be measured before starting treatment with eplerenone, during the first week, and one month after starting treatment or after any dose adjustment. Your doctor may adjust the dose based on your blood potassium levels.

Renal and hepatic impairment

If you have mild renal impairment, treatment should be initiated with one 25 mg tablet daily. If you have moderate renal impairment, treatment should be initiated with one 25 mg tablet on alternate days. These doses may be adjusted as directed by your doctor and according to your blood potassium levels.

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

No initial dose adjustment is required in patients with mild to moderate hepatic impairment. If you have liver or kidney disease, more frequent blood potassium monitoring may be necessary (see also "Do not take Eplerenona Vir").

Elderly patients

No initial dose adjustment is required.

Use in children and adolescents

Eplerenone is not recommended.

If you take more Eplerenona Vir than you should

If you take more eplerenone than you should, inform your doctor or pharmacist immediately. If you have taken an overdose, the most likely symptoms are low blood pressure (manifested as dizziness, blurred vision, weakness, or sudden loss of consciousness) or hyperkalaemia (high potassium levels in the blood) (manifested by muscle cramps, diarrhoea, nausea, dizziness, or headache). You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eplerenona Vir

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

Otherwise, take the tablet as soon as you remember, provided that more than 12 hours remain before the next scheduled dose. Then continue taking your medicine as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Eplerenona Vir

It is important to continue taking eplerenone as directed, unless your doctor advises you to stop treatment.

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 can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects:

Seek immediate medical attention

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

These are symptoms of angioedema, an uncommon adverse effect (may affect up to 1 in 100 people).

Other reported adverse effects include:

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

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

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

• infection
• eosinophilia (increase in certain white blood cells)
• dehydration
• elevated triglyceride (fat) levels in blood
• low sodium levels in blood
• rapid heartbeat
• inflammation of the gallbladder
• drop in blood pressure that may cause dizziness upon standing
• thrombosis (blood clot) in the legs
• sore throat
• flatulence
• hypothyroidism
• increased blood glucose levels
• reduced sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in certain blood test results

Reporting of adverse effects

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

5. Storage of Eplerenone Vir

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging 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 empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone Vir

• The active substance is eplerenone. Each tablet contains 50 mg of eplerenone.
• The other components are monohydrate lactose, 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).

Appearance of the product and contents of the pack:

50 mg tablet: yellowish-white, round, biconvex, film-coated tablet, marked with “E9RN” on one side and “50” on the other.

Eplerenone Vir is available in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 or 100 tablets; unit-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 certain 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

7071 Nijmegen-NL-6545 Netherlands

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 most recent review of this leaflet: August 2025

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