Package Insert: Information for the User

Eplerenone Vir 50 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to use the medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Eplerenona Vir contains the active substance eplerenone.

Eplerenone belongs to a group of medications 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. Elevated levels of aldosterone can produce changes in the 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 medications used to treat your heart failure or
2. persistent mild symptoms, despite the treatment you have been receiving up to this point.

Do not take Eplerenona Vir

• if you are allergic to eplerenona or any of the other components of this medication (listed in section 6)
• if you have high levels of potassium in your blood (hyperkalemia).
• if you are taking medications that help your body get rid of excess fluids (potassium-sparing diuretics) or "salt tablets" (potassium supplements).
• if you have severe kidney disease.
• if you have severe liver disease.
• if you are taking medications used to treat fungal infections (ketoconazole or itraconazole).
• if you are taking antiviral medications for HIV treatment (nelfinavir or ritonavir).
• if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin)
• if you are taking nefazodone to treat depression.
• if you are taking medications used to treat certain heart or high blood pressure conditions, such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Eplerenona Vir

• if you have kidney or liver disease (also see "Do not take Eplerenona Vir")
• if you are taking lithium (usually used to treat 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 organ transplant rejection)

Children and adolescents

The safety and effectiveness of eplerenona have not been established in children and adolescents.

Other medications and Eplerenona Vir

Inform your doctor or pharmacistif you are taking, have taken recently, or may need to take any other medication.

You should not take eplerenona with the following medications (see section "Do not take Eplerenona Vir"):

• Itraconazole or ketoconazole(used to treat fungal infections),ritonavir,nelfinavir(antiviral medications for HIV treatment),clarithromycin,telithromycin(used to treat bacterial infections) ornefazodone(used to treat depression), as these medications reduce the metabolism of eplerenona, and therefore prolong its effect in the body.
• Diuretics called potassium-sparing diuretics(medications that help your body get rid of excess fluid) orpotassium supplements(salt tablets), as these medications increase the risk of producing high levels of potassium in your blood.
• ACE inhibitors and an ARB at the same time(used to treat high blood pressure, heart disease, or certain kidney diseases) as these medications may increase the risk of high levels of potassium in your blood.

Please inform your doctor if you are taking any of the following medications:

• Lithium(usually used to treat manic-depressive disorder, also known as bipolar disorder). The use of lithium 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 cause the following side effects: loss of appetite; vision changes; fatigue; muscle weakness; muscle cramps.
• Cyclosporine or tacrolimus(used to treat skin conditions such as psoriasis or eczema, and to prevent organ transplant rejection). These medications may cause kidney problems and therefore increase the risk of high levels of potassium in your blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs)(certain pain relievers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medications may cause kidney problems and therefore 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 your 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 asneuroleptics) (such as chlorpromazine or haloperidol) (for the treatment of psychiatric disorders),amifostine(used during cancer chemotherapy) andbaclofen(used to treat muscle spasms). These medications 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 conditions) andtetracosactide(used primarily to diagnose and treat adrenal cortex diseases) may reduce the blood pressure-lowering effect of eplerenona.
• Digoxin(used in the treatment of heart disease). The levels of digoxin in your blood may increase when taken with eplerenona.
• Warfarin(an anticoagulant medication): Caution is required when taking warfarin because high levels of warfarin in your blood may cause changes in the effect of eplerenona on your body.
• Erythromycin(used to treat bacterial infections),saquinavir(an antiviral medication for HIV treatment),fluconazole(used to treat fungal infections),amiodarone,diltiazem, andverapamil(used to treat heart problems and high blood pressure) reduce the metabolism of eplerenona, prolonging its effect in your body.
• Hypericum perforatumorSt. John's Wort(a medicinal plant),rifampicin(used to treat bacterial infections),carbamazepine,phenytoin, andphenobarbital(used, among other things, to treat epilepsy) may increase the metabolism of eplerenona and therefore reduce its effect.

Taking Eplerenona Vir with food and drinks

Eplerenona can be taken with or without food.

Pregnancy and breastfeeding

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

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

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

Driving and operating machinery

After taking eplerenona, you may feel dizzy. If this happens, do not drive or operate machinery.

Eplerenona Vir contains lactose

If your doctor has told you that you have anintolerance to certain sugars, consult with them before taking this medication.

Eplerenona Vir contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, making it essentially "sodium-free".

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

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

Eplerenone is usually administered together with other medications for heart failure, for example, beta-blockers. The usual initial dose is one 25 mg tablet once a day, increasing after 4 weeks to 50 mg daily (one 50 mg tablet or two 25 mg tablets). The maximum daily dose is 50 mg.

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

Renal Insufficiency

If you have mild renal insufficiency, you should start treatment with one 25 mg tablet per day. If you have moderate renal insufficiency, you should start treatment with one 25 mg tablet every other day. These doses may be adjusted if your doctor indicates, 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 insufficiency. If you have any liver or kidney disease, you may need to have your blood potassium levels checked more frequently (see also “Do not take Eplerenone Vir”).

Older Patients

No dose adjustment is required.

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, inform your doctor or pharmacist immediately. If you have taken too much medication, the most likely symptoms will be low blood pressure (manifested as dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalemia, high levels of potassium in the blood (manifested by muscle cramps, diarrhea, nausea, dizziness, or headache).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Eplerenone Vir

If it is almost time to take the next tablet, skip the missed dose and take the next tablet at the usual time.

Otherwise, take the tablet as soon as you remember, as long as more than 12 hours have elapsed since the usual time for taking the next tablet. Then, resume your medication as usual. Do not take a double dose to compensate for the missed doses.

If You Stop Taking Eplerenone Vir

It is essential to continue taking eplerenone as instructed, unless your doctor tells you to stop treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience any of the following side effects:

Seek immediate medical attention

• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Blisters and difficulty breathing

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

Other reported side effects include:

Side effectsFrequent(may affect up to 1 in 10 people):

• Elevated potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• Fainting
• Dizziness
• High cholesterol levels in the blood
• Insomnia (difficulty sleeping)
• Headache
• Cardiac discomfort (e.g., irregular heartbeats and heart failure)
• Coughing
• Constipation
• Low blood pressure
• Diarrhea
• Nausea
• Vomiting
• Abnormal kidney function
• Rash
• Itching
• Back pain
• Weakness
• Muscle spasms
• Increased urea levels in the blood
• Elevated creatinine levels in the blood that may indicate kidney problems.

Side effectsRare(may affect up to 1 in 100 people):

• Infection
• Eosinophilia (increase in certain white blood cells)
• Dehydration
• High triglyceride levels (fats) in the blood
• Low sodium levels in the blood
• Fast heartbeats
• Biliary tract inflammation
• Low blood pressure that may cause dizziness when standing
• Thrombosis (blood clot) in the legs
• Sore throat
• Flatulence
• Hypothyroidism
• Increased glucose levels in the blood
• Decreased sense of touch
• Increased sweating
• Musculoskeletal pain
• General malaise
• Renal inflammation
• Increased breast tissue in men.
• Changes in certain blood tests

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Eplerenone 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), magnesium stearate (core of the tablet); hypromellose (E464), polysorbate 80 (E433), macrogol 400, titanium dioxide (E171), iron oxide yellow (E172) (tablet coating).

Appearance of the product and contents of the package:

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

Eplerenone 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 package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923 Alcorcón, Madrid

Spain

Responsible manufacturer

SYNTHON HISPANIA, S.L

Castello 1, Poligono 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. Poligono 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 with the following names:

This leaflet was revised in January 2021

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