EPLERENONE VIATRIS 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

1. What is Eplerenone Viatris and what is it 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 controls blood pressure and cardiac function. High levels of aldosterone can cause changes in your body that lead to heart failure.

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

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

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

Do not take Eplerenone Viatris:

• 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 used to treat HIV (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 medicines used to treat certain heart conditions or high blood pressure (such as ACE inhibitors and angiotensin receptor antagonists) at the same time.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Eplerenone Viatris:

• If you have kidney or liver disease (see also "Do not take Eplerenone Viatris").
• If you are taking lithium (usually used for manic-depressive disorders, also called bipolar disorder).
• If you are taking tacrolimus or cyclosporin (used to treat skin diseases such as psoriasis or eczema and to prevent organ rejection after transplantation).

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 using, have recently used or might use any other medicines, including those obtained without a prescription.

Do 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 used to treat 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) and potassium supplements (salt tablets), as these medicines increase the risk of high levels of potassium in the blood.
• ACE inhibitors and angiotensin receptor antagonists 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.

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

• Lithium (usually used for manic-depressive disorders, also called 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 adverse reactions: loss of appetite, vision changes, fatigue, muscle weakness and muscle cramps.
• Cyclosporin or tacrolimus (used to treat skin diseases such as psoriasis or eczema and to prevent organ rejection after transplantation). These medicines can cause kidney problems and thus increase the risk of high levels of potassium in the blood.
• Non-steroidal anti-inflammatory medicines (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 the 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.
• Corticosteroids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin diseases) and tetracosactide (mainly used 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 administering warfarin doses because high levels of warfarin in the blood may alter the effect of eplerenone in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine used to treat HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem and verapamil (for the treatment of heart problems and high blood pressure) because they reduce the metabolism of eplerenone, thus prolonging its effect in the body (see section 3 "How to take Eplerenone Viatris").
• 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.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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 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 told you that you have an intolerance to some sugars, consult with them 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 administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

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

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

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 recommends it, and according to your potassium blood levels.

Eplerenone Viatris is not recommended in patients with severe kidney disease.

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 Viatris").

If you are taking any other medicines, your doctor may recommend that you take a lower dose.

For elderly patients: no initial dose adjustment is necessary.

For children and adolescents: Eplerenone Viatris is not recommended.

Taking your medicine

Eplerenone tablets can 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, 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, fainting, blurred vision, weakness, 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Eplerenone Viatris

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 next dose. Go back to taking your medicine as usual.

Do not take a double dose to make up for forgotten doses.

If you stop taking Eplerenone Viatris

It is important to keep taking Eplerenone Viatris as prescribed by your doctor, 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 any of the following happen, seek medical attention immediately:

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

• Heart problems, such as irregular heartbeat and heart failure.
• Abnormal kidney function – you may notice little or no urine, or notice pain in the lower back.

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

• Gallbladder inflammation – you may have sudden severe stomach pain that may spread to the shoulders.
• Blood clots in the legs.
• Kidney inflammation – you may notice pain in the lower back, cloudy urine or blood in the urine.
• Swelling of the face, tongue or throat, difficulty swallowing, blisters and difficulty breathing, these are symptoms of angioedema.

Other side effects reported include:

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

• High levels of potassium in the blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness or headache).
• Dizziness.
• Fainting.
• Infection.
• Cough.
• Constipation.
• Low blood pressure.
• Diarrhea.
• Feeling sick (nausea) or being sick (vomiting).
• Headache.
• Difficulty sleeping (insomnia).
• Rash.
• Itching.
• Muscle spasms and pain.
• Back pain.
• High levels of urea in the blood.
• General malaise.
• High levels of cholesterol or triglycerides (fats) 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):

• Eosinophilia (an increase in certain white blood cells).
• Dehydration.
• Low levels of sodium in the blood.
• Fast heart rate.
• Low blood pressure that may cause dizziness when standing up.
• Sore throat.
• Flatulence.
• Underactive thyroid.
• High blood sugar levels.
• Decreased sense of touch.
• Increased sweating.
• General malaise.
• Enlargement of the breasts in men.
• Changes in certain blood tests.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Eplerenona Viatris

• The active ingredient is eplerenone. Each film-coated tablet contains 50 mg of eplerenone.
• The other ingredients are:

Tablet Core

Lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, talc, magnesium stearate (see section 2, "Eplerenona Viatris contains lactose and sodium").

Film Coating

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

Appearance and Packaging of the Product

Eplerenona Viatris 50 mg are yellow, round, biconvex film-coated tablets marked with "EP2" on one side and "M" on the other.

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

Only some 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

Further information on this medicinal product can be obtained from the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Belgium:Eplerenone Mylan 50 mg film-coated tablets

Spain:Eplerenona Viatris 50 mg film-coated tablets EFG

France:Eplerenone Mylan 50 mg, film-coated tablet

Hungary:Eplerenone Mylan 50 mg film tablet

Ireland:Eplerenone Mylan 50 mg Film-coated Tablets

Italy:Eplerenone Mylan

Luxembourg:Eplerenone Mylan 50 mg film-coated tablets

Netherlands:Eplerenon Mylan 50 mg, film-coated tablets

United Kingdom:Eplerenone 50 mg Film-coated tablets

Slovak Republic:Eplerenon Mylan 50 mg, film-coated tablets

Date of last revision of this leaflet: March 2018

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