Prospect: information for the patient

Eplerenone Viatris 50 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine 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 prospect. See section 4.

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

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

3.How to take Eplerenone Viatris

4.Possible adverse effects

5.Storage of Eplerenone Viatris

6.Contents of the package and additional information

Eplerenona Viatris 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.

Eplerenona 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 medications used to treat your heart failure, or

2. You have persistent mild symptoms, despite the treatment you have been receiving up to this point.

Do not take Eplerenona Viatris:

• If you are allergic to eplerenone 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 eliminate excess fluids in the body (potassium-sparing diuretics).
• 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 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 medications used to treat certain heart or high blood pressure conditions (such as ACE inhibitors and ARBs) at the same time.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Eplerenona Viatris:

• If you have kidney or liver disease (also see “Do not take Eplerenona Viatris”).
• If you are taking lithium (usually used to treat manic-depressive disorders, 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 efficacy of eplerenone have not been established in children and adolescents.

Other medications and Eplerenona Viatris

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

You should not take Eplerenona Viatris with the following medications (see section “Do not take Eplerenona Viatris”):

• Ketoconazole or itraconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medications for HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medications reduce the metabolism of eplerenone, and therefore, prolong its effect in the body.
• Potassium-sparing diuretics and potassium supplements (tablets), as these medications increase the risk of high potassium levels in the blood.
• ACE inhibitors and ARBs 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 potassium levels in the blood.

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

• Lithium (used to treat manic-depressive disorders, 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 lithium levels in the blood, which may cause the following adverse reactions: loss of appetite, vision changes, fatigue, muscle weakness, and 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 potassium levels in the 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 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 diseases), which may cause a decrease in blood pressure and dizziness when standing up.
• Tricyclic antidepressants such as amitriptyline or amoxapine (used to treat depression), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (used to treat psychiatric disorders), amifostine (used during cancer chemotherapy), and baclofen (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) and tetracosactide (used primarily to diagnose and treat adrenal gland disorders) may reduce the blood pressure-lowering effect of eplerenone.
• Digoxin (used to treat heart conditions). The levels of digoxin in the blood may increase when taken with eplerenone.
• Warfarin (an anticoagulant medication): 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 medication for HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart conditions and high blood pressure), which may reduce the metabolism of eplerenone, prolonging its effect in the body (see section 3 “How to take Eplerenona Viatris”).
• St. John's Wort (a medicinal plant), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among other things, to treat epilepsy) may increase the metabolism of eplerenone and therefore reduce its effect.

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. Eplerenone has not been evaluated during human pregnancy.

The safety of eplerenone during breastfeeding is unknown. Your doctor will decide with you whether to interrupt treatment or breastfeeding.

Driving and operating machinery

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

Eplerenona Viatris contains lactose and sodium

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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 a day, increasing subsequently after 4 weeks to 50 mg daily (one 50 mg tablet or two 25 mg tablets). The maximum dosage regimen is 50 mg per day.

Measurements of potassium in the blood should be performed before starting treatment with Eplerenone Viatris 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 potassium levels in the blood.

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 recommends it, and in accordance with your potassium blood levels.

Eplerenone Viatris is not recommended for patients with severe renal disease.

No initial dose adjustment is necessary for patients with mild to moderate liver insufficiency. If you have any liver or kidney disease, you may need to have your potassium blood levels measured 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.

Medication intake

Eplerenone tablets can be taken with food or on an empty stomach. 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 medication, the most likely symptoms will be low blood pressure (manifested as dizziness, vertigo, 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 Viatris

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 time for the next tablet. Resume your medication as usual.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eplerenone Viatris

It is essential to continue taking Eplerenone Viatris as prescribed, 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 medicines, this medicine may cause side effects, although not everyone will experience them.

If any of the following occur, seek medical attention immediately:solicite atención médica inmediatamente:

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

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

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

• Cholecystitis (inflammation of the gallbladder) – may have sudden sharp pain in the stomach that could extend to the shoulders.
• Thrombosis (blood clot) in the legs.
• Renal inflammation – may notice pain in the lower back, cloudy urine or blood in the urine.
• Angioneurotic edema – swelling in the face, tongue or throat, difficulty swallowing, blisters and difficulty breathing.

Other side effects reported include:

Frequent 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.
• Diarhea.
• Nausea or vomiting.
• Headache.
• Difficulty sleeping (insomnia).
• Skin rash.
• Itching.
• Muscle spasms and pain.
• Back pain.
• Increased levels of urea in the blood.
• General feeling of being unwell.
• High levels of cholesterol or triglycerides (fats) in the blood.
• Elevated levels of creatinine in the blood that may indicate kidney problems.

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

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

Reporting 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 leaflet. You can also report them directly to 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 medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date (EXP) shown on the packaging and the blister pack. The expiration date is the last day of the month indicated.

Do not dispose of medications through the drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Eplerenone Viatris Composition

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

Tablet Core

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

Film Coating

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

Appearance of the Product and Contents of the Package

Eplerenone Viatris 50 mg are yellow, round, biconvex, film-coated tablets marked with “EP2” on one face and “M” on the other.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 about this medicinal product, please contact 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 filmomhulde tabletten

Spain:Eplerenone Viatris 50 mg comprimidos recubiertos con película EFG

France:Eplerenone Mylan 50 mg, comprimé pelliculé

Hungary:Eplerenone Mylan 50 mg filmtabletta

Ireland:Eplerenone Mylan 50 mg Film-coated Tablets

Italy:Eplerenone Mylan

Luxembourg:Eplerenone Mylan 50 mg comprimés pelliculés

Netherlands:Eplerenon Mylan 50 mg, filmomhulde tabletten

United Kingdom:Eplerenone 50 mg Film-coated tablets

Slovak Republic:Eplerenon Mylan 50 mg, filmom obalené tablety

Last revision date of this leaflet: March 2018

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/