Eplerenone Viatris 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Eplerenona Viatris 25 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, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Eplerenone Viatris 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 lead to heart failure.

Eplerenone Viatris is used to treat heart failure, to prevent its worsening, and to reduce hospitalization when:

1. You have recently had a myocardial infarction, in combination with other medicines used to treat your heart failure, or
2. You have persistent mild symptoms despite the treatment you have been receiving up to now.

2. What you need to know before taking Eplerenone Viatris

Do not take Eplerenone Viatris:

• 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 that help your body get rid of excess fluid (potassium-sparing diuretics).
• If you have severe kidney failure.
• If you have severe liver failure.
• If you are taking medicines used to treat fungal infections (ketoconazole or itraconazole).
• If you are taking antiviral medicines used to treat HIV infection (nelfinavir or ritonavir).
• If you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin).
• If you are taking nefazodone for depression.
• If you are taking, at the same time, medicines used to treat certain heart conditions or high blood pressure (such as angiotensin-converting enzyme [ACE] inhibitors and angiotensin receptor blockers [ARBs]).

Warnings and precautions

Talk to your doctor or pharmacist before taking Eplerenone Viatris:

• If you have kidney or liver disease (see also “Do not take Eplerenone Viatris”).
• If you are taking lithium (commonly used for manic-depressive disorders, also called 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 have not been established.

Other medicines and Eplerenone Viatris

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.

You must not take Eplerenone Viatris with the following medicines (see section “Do not take Eplerenone Viatris”):

• 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) and potassium supplements (salt tablets), as these medicines increase the risk of developing high potassium levels in the blood.
• Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) taken together (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medicines may increase the risk of developing high potassium levels in the blood.

Inform your doctor if you are taking any of the following medicines:

• Lithium (commonly used for manic-depressive disorders, also called 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 reactions: loss of appetite, vision disturbances, fatigue, muscle weakness, and 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 the 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), which 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), which 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 (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 (mainly used to diagnose and treat adrenal cortex disorders), which 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 administering warfarin doses, as 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 treating HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for the treatment of heart problems and high blood pressure), as they reduce the metabolism of eplerenone, thereby prolonging its effect in the body (see section 3 “How to take Eplerenone Viatris”).
• 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 thus reduce its effect.

Pregnancy and breastfeeding

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. 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 using machines

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

Eplerenone Viatris contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Eplerenone Viatris

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

Eplerenone is usually administered together with other medications for heart failure, e.g., beta-blockers. The recommended initial dose is one 25 mg tablet once daily, increasing after approximately 4 weeks to 50 mg daily (one 50 mg tablet or two 25 mg tablets). The maximum dosage regimen is 50 mg per day.

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

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 every other day. These doses may be adjusted, if recommended by your doctor, according to your blood potassium levels.

Eplerenone Viatris is not recommended in patients with severe renal impairment.

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

If you are taking any other medication, your doctor may recommend a lower dose.

For elderly patients: no initial dose adjustment is required.

For children and adolescents: Eplerenone Viatris is not recommended.

How to take your medicine

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

If you take more Eplerenone Viatris than you should

If you take more Eplerenone Viatris than you should, inform your doctor or pharmacist immediately. If you have taken too much medicine, the most likely symptoms are low blood pressure (manifested as dizziness, fainting, blurred vision, weakness, acute loss of consciousness) or hyperkalaemia, high levels of potassium in the blood (manifested by muscle cramps, diarrhoea, nausea, dizziness, or headache).

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

If you forget to take Eplerenone Viatris

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 Eplerenone Viatris

It is important to continue taking Eplerenone Viatris as prescribed, unless your doctor tells 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 any of the following occur, seek immediate medical attention:

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

• Heart problems, for example, irregular heartbeat and heart failure.
• Abnormal kidney function – you may notice little or no urine, or feel pain in your lower back.

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

• Inflammation of the gallbladder – you may have sudden, severe stomach pain that could spread to the shoulders.
• Blood clot (thrombosis) in the legs.
• Kidney inflammation – you may notice pain in your lower back, cloudy urine, or blood in the urine.
• Swelling of the face, tongue or throat, difficulty swallowing, blistering and difficulty breathing, which are symptoms of angioedema.

Other reported adverse effects include:

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

• High levels of potassium in the blood (symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache).
• Dizziness.
• Fainting.
• Infection.
• Cough.
• Constipation.
• Low blood pressure.
• Diarrhoea.
• Feeling unwell (nausea) or being unwell (vomiting).
• Headache.
• Difficulty sleeping (insomnia).
• Skin rash.
• Itching.
• Muscle spasms and muscle pain.
• Back pain.
• Increased levels of urea in the blood.
• General malaise.
• Elevated levels of cholesterol or triglycerides (fats) in the blood.
• Increased levels of creatinine in the blood, which may indicate kidney problems.

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

• Eosinophilia (increase in certain white blood cells).
• Dehydration.
• Low levels of sodium in the blood.
• Rapid heartbeat.
• Drop in blood pressure that may cause dizziness when standing up.
• Sore throat.
• Flatulence.
• Underactive thyroid gland.
• Increased blood glucose.
• Reduced sense of touch.
• Increased sweating.
• General malaise.
• Breast enlargement in men.
• Changes in certain blood tests.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Viatris

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date (EXP) stated on the packaging and blister. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone Viatris

• The active substance is eplerenone. Each film-coated tablet contains 25 mg of eplerenone.
• The other components are:

Tablet core

Monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, talc, magnesium stearate (see section 2, “Eplerenone Viatis contains lactose and sodium”).

Film coating

Hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), red iron oxide (E172), polysorbate.

Nature of the product and pack contents

Eplerenone Viatris 25 mg are yellow, round, biconvex, film-coated tablets marked with “EP1” on one side and “M” on the other.

Eplerenone Viatris is available in blisters containing 20, 28, 30, 50, 90 and 100 tablets, in single-dose perforated blisters containing 30, 50 and 90 tablets, or in plastic bottles containing 28, 30, 90 and 250 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

McDermott Laboratories t/a Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13,
Ireland

or

Mylan Hungary Kft.
Mylan utca 1
H-2900, Komarom
Hungary

or

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta

or

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

For further information on this medicine, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Eplerenone Mylan 25 mg filmomhulde tabletten
Spain: Eplerenona Viatris 25 mg comprimidos recubiertos con película EFG
France: Eplerenone Mylan 25 mg, comprimé pelliculé
Hungary: Eplezot 25 mg filmtabletta
Ireland: Eplerenone Mylan 25 mg Film-coated Tablets
Italy: Eplerenone Mylan
Luxembourg: Eplerenone Mylan 25 mg comprimés pelliculés
Netherlands: Eplerenon Mylan 25 mg filmomhulde tabletten
United Kingdom: Eplerenone 25 mg Film-coated tablets
Slovak Republic: Eplerenon Mylan 25 mg, filmom obalené tablety

Date of the most recent review of this leaflet: February 2021

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