EPLERENONE AUROVITAS SPAIN 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eplerenone Aurovitas Spain 25 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 experience 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 and other information

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

1. What Eplerenone Aurovitas Spain is and what it is used for

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 controls blood pressure and cardiac function. High levels of aldosterone can cause changes in your body that lead to heart failure.

Eplerenone is used to treat heart failure to prevent worsening and reduce hospitalization if you have:

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

2. What you need to know before you take Eplerenone Aurovitas Spain

Do not take Eplerenone Aurovitas Spain

• if you are allergic to eplerenone or any of the other ingredientsof 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 for HIV treatment(ritonavir or nelfinavir).
• if you are taking antibiotics used to treat bacterial infections(clarithromycin or telithromycin).
• if you are taking nefazodoneto treat depression.
• if you are taking medicines used to treat certain heart disorders or high blood pressure (such as ACE inhibitors and angiotensin receptor antagonists) at the same time.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Eplerenone Aurovitas Spain:

• if you have kidney or liver disease(see also “Do not take Eplerenone Aurovitas Spain”).
• if you are taking lithium(usually used for manic-depressive disorders, also called bipolar disorder).
• if you are taking tacrolimus or cyclosporine(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.

Using Eplerenone Aurovitas Spain with other medicines

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

• Itraconazole or ketoconazole(used to treat fungal infections), ritonavir, nelfinavir(antiviral medicines for HIV treatment), 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, such as spironolactone, amiloride, and triamterene) and potassium supplements(salt tablets), as these medicines increase the risk of high levels of potassium in your 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.

• Lithium(used to treat manic-depressive disorder, 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 side effects: loss of appetite; vision changes; fatigue; muscle weakness; muscle cramps.
• Cyclosporine 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 your 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 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 lead to 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 lead to 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(used primarily 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 taking warfarin because 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 HIV treatment), fluconazole(used to treat fungal infections), amiodarone, diltiazem, and verapamil(for the treatment of heart problems and high blood pressure) reduce the metabolism of eplerenone, thus prolonging its effect in the body.
• St. John's Wort(a herbal remedy), 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.

Taking Eplerenone Aurovitas Spain with food and drinks

Eplerenone can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 stop breast-feeding or stop treatment.

Driving and using machines

After taking eplerenone, you may feel dizzy. If this happens, do not drive or use machines.

Eplerenone Aurovitas Spain contains lactose monohydrate

This medicine contains lactose monohydrate (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Eplerenone Aurovitas Spain contains sodium

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

3. How to take Eplerenone Aurovitas Spain

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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

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

Potassium levels in the blood should be measured 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 potassium levels in the blood. This is especially important if you are elderly, have kidney disease, or diabetes, as you have a higher risk of having high potassium levels.

If you have mild kidney problems, you should start treatment with one 25 mg tablet per day, and if you have moderate kidney problems, 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.

Eplerenone tablets are recommended in patients with severe kidney disease.

No initial dose adjustment is necessary in patients with mild to moderate liver problems. If you have liver or kidney problems, you may need to have your potassium levels in the blood checked more frequently (see also “Do not take Eplerenone Aurovitas Spain”).

In elderly patients: no initial dose adjustment is necessary.

Use in children and adolescents

In children and adolescents: eplerenone is not recommended.

If you take more Eplerenone Aurovitas Spain than you should

If you take more eplerenone 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, blurred vision, weakness, sudden 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, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eplerenone Aurovitas Spain

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 more than 12 hours have passed since the time you should have taken it. Then take your medicine as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Eplerenone Aurovitas Spain

It is important to keep taking eplerenone as your doctor has told you, unless your doctor tells you to stop.

If you have any further questions on the use of this product, 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

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

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

Other side effects reported include:

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

• high levels of potassium in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• dizziness
• fainting
• high levels of cholesterol in your blood
• difficulty sleeping (insomnia)
• headache
• heart problems, such as irregular heartbeats and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasms
• increased levels of urea 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

• infection
• increase in certain white blood cells (eosinophilia)
• dehydration
• high levels of triglycerides (fats) in your blood
• low levels of sodium in the blood
• rapid heartbeat
• inflammation of the gallbladder
• low blood pressure that can cause dizziness when standing up
• blood clots in the leg
• sore throat
• flatulence
• hypothyroidism
• high blood sugar
• decreased sense of touch
• increased sweating
• general malaise
• musculoskeletal pain
• kidney inflammation
• breast enlargement in men
• changes in some blood test results

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Aurovitas Spain

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone Aurovitas Spain

• The active substance is eplerenone. Each tablet contains 25 mg of eplerenone.
• The other ingredients 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), yellow iron oxide (E172) (tablet coating).

Appearance of the product and pack contents

Light yellow, round, biconvex film-coated tablet, approximately 6 mm in diameter. The tablet is marked with “E9RN” on one side and “25” on the other.

Eplerenone Aurovitas Spain 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.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Generis Farmacêutica, S.A.

Rua Joao de Deus, nº 19, Venda Nova,

2700-487 Amadora

Portugal

Or

APL Swift Services (Malta) Ltd.

HF26 Hal Far Industrial Estate, Hal Far,

Birzebbugia BBG 3000

Malta

Date of last revision of this leaflet:June 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)