Prospecto: information for the user

Elecor 25 mg film-coated tablets

eplerenone

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

• Keep this prospectus, 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 you must 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 prospectus. See section 4.

1.What isElecorand for what it is used

2.What you need to know before starting to takeElecor

3.How to takeElecor

4.Possible adverse effects

5.Storage ofElecor

6.Contents of the package and additional information

Elecorbelongs 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 may lead to heart failure.

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

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

Do not take Elecor

• if you are allergic to eplerenone or any of the other ingredients 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 your body get rid of excess fluids (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 medications used to treat HIV infections (ritonavir or nelfinavir).
• 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 angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs), at the same time.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Elecor.

• if you have kidney or liver disease (see “Do not take Elecor”)
• 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 in children and adolescents have not been established.

Other medications and Elecor

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

• 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 ofElecor, and therefore prolong its effect in the body.
• potassium-sparing diuretics or 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.
• 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 that 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): 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): 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 ofElecor.
• digoxin (used to treat heart conditions). The levels of digoxin in the blood may increase when taken withElecor.
• warfarin (an anticoagulant medication): caution is required when administering warfarin doses as high levels of warfarin in the blood may cause changes toElecorin the body.
• erythromycin (used to treat bacterial infections), saquinavir (antiviral medication for HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart conditions and high blood pressure) as these medications reduce the metabolism ofElecor, and therefore prolong its effect in the body.
• St. John's Wort (Hypericum perforatum), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy) may increase the metabolism ofElecorand therefore reduce its effect.

Elecor with food and drink

Elecor can be taken with or without food.

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.The effect ofElecorhas not been evaluated in humans during pregnancy.

The elimination of eplerenone in breast milk is unknown. Your doctor will decide with you whether to stop treatment or breastfeeding.

Driving and operating machinery

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

Elecor contains lactose

Elecorcontains lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

Blood potassium determinations should be performed before starting treatment withElecor, 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 blood 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 in accordance with your blood potassium levels.

Elecoris not recommended for patients with severe renal disease.

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

In elderly patients: no initial dose adjustment is required.

In children and adolescents:Elecoris not recommended.

If you take more Elecor than you should

If you take moreElecorthan 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 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 Elecor

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 were supposed to take 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 Elecor

It is essential to continue takingElecoras indicated by your doctor, 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 medications, this medication may 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 angioneurotic edema, a rare side effect (affecting up to 1 in 100 people).

Other reported side effects include:

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

• Elevated potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• Fainting
• Dizziness
• High cholesterol levels in the blood
• Insomnia (difficulty sleeping)
• Headache
• Cardiac discomfort, for example, irregular heartbeats and heart failure
• Cough
• Constipation
• Low blood pressure
• Diarrhea
• Nausea
• Vomiting
• Abnormal kidney function
• Rash
• Itching
• Back pain
• Weakness
• Muscle spasms
• Increased urea levels in the blood
• Elevated creatinine levels in the blood that may indicate kidney problems

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

• Infection
• Eosinophilia (increase in certain white blood cells)
• Low sodium levels in the blood
• Dehydration
• High triglyceride levels (fats) in the blood
• Fast heartbeats
• Bile duct inflammation
• Low blood pressure that may cause dizziness when standing up
• Thrombosis (blood clot) in the legs
• Sore throat
• Flatulence
• Underactive thyroid
• Increased blood glucose
• Decreased sense of touch
• Increased sweating
• Musculoskeletal pain
• General discomfort
• Kidney inflammation
• 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 that appears on the packaging and outer carton after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Elecor

The active ingredient of the film-coated tablets ofElecoris eplerenone. Each tablet contains 25 mg of eplerenone.

The other components are lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), sodium lauryl sulfate, talc (E553b), and magnesium stearate (E470b).

The opadry yellow coating ofElecor25 mg film-coated tablets contains hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of Elecorand contents of the packaging

TheElecor25 mg tablet is a yellow film-coated tablet. It is marked with “NSR” above “25”.

Elecor25 mg film-coated tablets are presented in blister packs containing 30, 50, or 200 tablets. Possible commercialization of only some packaging sizes.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almirall, S.A. General Mitre, nº 151 08022 – Barcelona (Spain).

Responsible manufacturer

Fareva Amboise. Zone Industrielle-29 route des Industries. 37530 Pocé-sur-Cisse (France)

Last review date of this leaflet: August 2022

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