Package Insert: Information for the User

Eplerenona Aurovitas Spain 25mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it 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 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 is used to treat heart failure to prevent worsening and reduce hospitalization if you have:

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

Do not takeEplerenona Aurovitas Spain

• if you areallergic to eplerenone or any of the other ingredientsof this medicine (listed in section 6).
• if you havehigh levels of potassiumin your blood (hyperkalemia).
• if you are takingmedicines that help your body get rid of excess fluid(potassium-sparing diuretics).
• if you havesevere kidney disease.
• if you havesevere liver disease.
• if you are takingmedicines used to treat fungal infections(ketoconazole or itraconazole).
• if you are takingmedicines to treat HIV(ritonavir or nelfinavir).
• if you are takingantibiotics used to treat bacterial infections(clarithromycin or telithromycin).
• if you are takingnefazodone to treat depression.
• if you are takingmedicines used to treat certain heart or high blood pressure conditions(such as ACE inhibitors and angiotensin receptor blockers).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Eplerenona Aurovitas Spain:

• if you havekidney or liver disease(see also “Do not takeEplerenona Aurovitas Spain”).
• if you are takinglithium(usually used to treat manic-depressive disorders, also known as bipolar disorder).
• if you are takingtacrolimus or ciclosporin(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.

Use of Eplerenona Aurovitas Spain with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

• Itraconazole or ketoconazole(used to treat fungal infections),ritonavir,nelfinavir(medicines to treat HIV),clarithromycin,telithromycin(used to treat bacterial infections) ornefazodone(used to treat depression), as these medicines reduce the metabolism of eplerenone, and therefore 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) andpotassium supplements(salt tablets), as these medicines increase the risk of high potassium levels in your blood.
• Medicines that increase the risk of high potassium levels in your blood:
• 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 high levels of lithium in the blood, which can cause the following side effects: loss of appetite; visual disturbances; fatigue; muscle weakness; muscle cramps.
• Tacrolimus or ciclosporin(used to treat skin conditions such as psoriasis or eczema, and to prevent organ transplant rejection). These medicines can cause kidney problems and therefore increase the risk of high potassium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs)(certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines can cause kidney problems and therefore increase the risk of high potassium levels in your blood.
• Trimethoprim(used to treat bacterial infections) may increase the risk of high potassium levels in your blood.
• Alpha-1 blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions) may cause a drop 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 medicines may cause a drop in blood pressure and dizziness when standing up.
• Glucocorticoids(such as hydrocortisone or prednisone) (used to treat inflammation and certain skin conditions) andtetracosactide(used mainly 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 your blood may increase when taken with eplerenone.
• Warfarin(an anticoagulant): Caution is required when taking warfarin, as high levels of warfarin in the blood may affect 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, andverapamil(used to treat heart conditions and high blood pressure) reduce the metabolism of eplerenone, prolonging its effect in the body.
• St. John's Wort(a medicinal plant),rifampicin(used to treat bacterial infections),carbamazepine,phenytoin, andphenobarbital(used to treat epilepsy) may increase the metabolism of eplerenone and therefore reduce its effect.

Taking Eplerenona Aurovitas Spain with food and drink

Eplerenone can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Eplerenone has not been evaluated in human pregnancy. It is not known whether eplerenone is excreted in breast milk. Your doctor will decide with you whether to stop breastfeeding or discontinue treatment.

Driving and operating machinery

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

Eplerenona Aurovitas Spain contains lactose monohydrate

This medicine contains lactose monohydrate (a type of sugar). If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medicine.

Eplerenona Aurovitas Spain contains sodium

This medicine 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. In case of doubt, consult your doctor or pharmacist again.

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

Eplerenona is usually administered together with other medications for heart failure, for example, beta-blockers. The recommended initial dose is one 25 mg tablet once a day, increasing subsequently 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.

It is necessary to measure the levels of potassium in the blood before starting treatment with eplerenona, during the first week, and one month after starting treatment or after a change in dose. Your doctor will be able to adjust the dose based on your potassium levels in the blood. This is especially important if you are an elderly person, have kidney disease or diabetes, as you have a higher risk of having high potassium levels.

If you have mild renal insufficiency, you should start treatment with one 25 mg tablet per day, and 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 potassium blood levels.

Eplerenona tablets are not recommended for patients with severe kidney disease.

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

In elderly patients: no initial dose adjustment is required.

Use in children and adolescents

In children and adolescents: eplerenona is not recommended.

If you take more Eplerenona Aurovitas Spain than you should

If you take more eplerenona 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 potassium levels 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 forgot to take Eplerenona Aurovitas Spain

If it is almost time to take the next tablet, skip the dose you forgot and take the next tablet at the usual time. Otherwise, take the tablet as soon as you remember, provided it has been more than 12 hours since the time you should have taken the next tablet. Then, resume your medication as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eplerenona Aurovitas Spain

It is essential to continue taking eplerenona as indicated, 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 can cause side effects, although not everyone will experience them.

If any of the following occur:

Seek immediate medical attention

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

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

Other reported side effects include:

Side effectsFrequent:can 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 the blood
• Difficulty sleeping (insomnia)
• Headache
• Cardiac discomfort, such as irregular heartbeats and heart failure
• Cough
• Constipation
• Low blood pressure
• Diarrhea
• Nausea
• Vomiting
• Abnormal kidney function
• Rash
• Itching
• Back pain
• Weakness
• Spasms
• Increased levels of urea in the blood
• Increased levels of creatinine in the blood that may indicate kidney problems

Side effectsRare:can affect up to 1 in 100 people

• Infection
• Increased levels of certain white blood cells (eosinophilia)
• Dehydration
• High levels of triglycerides (fats) in the blood
• Low levels of sodium in the blood
• Fast heartbeats
• Inflammation of the gallbladder
• Low blood pressure that can cause dizziness when standing up
• Thrombosis (blood clot) in the leg
• Sore throat
• Flatulence
• Hypothyroidism
• Increased blood sugar
• Decreased sense of touch
• Increased sweating
• General discomfort
• Musculoskeletal pain
• Inflammation of the kidney
• Enlargement of the breasts in men
• Changes in some blood test results

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 leaflet. You can also report them directly through the Spanish System for the 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.

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.

This medication does not require special storage conditions.

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 your 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.

Composition ofEplerenona Aurovitas Spain

• The active ingredient is eplerenone. Each tablet contains 25mg of eplerenone.
• The other components are lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), sodium lauryl sulfate, talc (E553b), magnesium stearate (tablet core); hypromellose (E464), polysorbate 80 (E433), macrogol 400, titanium dioxide (E171), yellow iron oxide (E172) (tablet coating).

Appearance of the productand content of the container

Yellowish clear-coated tablet, round, biconvex, with a diameter of approximately 6 mm. The tablet is marked with “E9RN” on one side and “25” on the other.

Eplerenona 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, 60x1, 84 x 1, 90 x 1, 98 x 1, or 100 x 1 tablets.

Only some sizes of packaging may be commercially marketed.

Marketing authorization holderand manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Generis Farmacêutica, S.A.

Rua Joao de Deus, nº19, Venda Nova,

2700-487 Amadora

Portugal

Or

APL swift Services (Malta) Ltd.

HF26 Hal Far Industrial Estate, Hal Far,

Birzebbugia BBG 3000

Malta

Last review date of this leaflet:June 2022

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