Elecor 50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Elecor 50 mg film-coated tablets

eplerenone

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Elecor is and what it is used for

Elecor 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 regulates blood pressure and heart function. Elevated levels of aldosterone can cause changes in the body that may lead to heart failure.

Elecor is used to treat heart failure to prevent its worsening and reduce hospitalization in patients who have:

1. recently suffered a myocardial infarction, in combination with other medicines used to treat heart failure, or
2. persistent mild symptoms despite ongoing treatment.

2. What you need to know before taking Elecor

Do not take Elecor

• if you are allergic to eplerenone or to any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of potassium in your blood (hyperkalaemia).
• if you are taking medicines from groups that help your body eliminate excess fluid (potassium-sparing diuretics).
• if you have severe renal impairment.
• if you have severe hepatic impairment.
• if you are taking medicines used to treat fungal infections (ketoconazole or itraconazole).
• if you are taking medicines 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 for depression.
• if you are simultaneously taking medicines used to treat certain heart conditions or high blood pressure, such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARBs).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Elecor:

• if you have kidney or liver disease (see “Do not take Elecor”)
• if you are taking lithium (commonly used for 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 rejection of transplanted organs)

Children and adolescents

The safety and efficacy of eplerenone in children and adolescents has not been established.

Other medicines and Elecor

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

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for treating AIDS), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the metabolism of Elecor, thereby prolonging its effect in the body.
• Potassium-sparing diuretics (medicines that help eliminate excess fluid from the body) or potassium supplements (salt tablets), as these medicines increase the risk of high potassium levels in the blood.
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) taken together (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medicines may increase the risk of high potassium levels in the blood.
• Lithium (commonly used for manic-depressive disorders, also known as bipolar disorder). The use of lithium together with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) has been shown to cause excessively high levels of lithium in the blood, which may lead to adverse reactions such as loss of appetite, vision disturbances, fatigue, muscle weakness, and muscle cramps.
• Cyclosporine or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent rejection of transplanted organs). These medicines may cause kidney problems and thus increase the risk of high potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs – certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines may cause kidney problems and thus 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 conditions): may lead to a drop in blood pressure and dizziness upon standing.
• Tricyclic antidepressants such as amitriptyline or amoxapine (for the treatment of depression), antipsychotics (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 drop in blood pressure and dizziness upon standing.
• Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions) and tetracosactide (used mainly to diagnose and treat adrenal cortex disorders), may reduce the blood pressure-lowering effect of Elecor.
• Digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with Elecor.
• Warfarin (an anticoagulant medicine): caution is required when administering warfarin doses, as high levels of warfarin in the blood may be affected by changes caused by Elecor in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for treating HIV infection), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for the treatment of heart problems and high blood pressure) may reduce the metabolism of Elecor, thereby prolonging its effect in the body.
• Hypericum perforatum (St. John's wort), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy) may increase the metabolism of Elecor and thereby reduce its effect.

Taking Elecor with food and drink

Elecor can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. The effect of Elecor during pregnancy has not been evaluated in humans.

It is unknown 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 Elecor, you may feel dizzy. If this occurs, do not drive or operate machinery.

Elecor contains lactose

Elecor contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Elecor

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Elecor tablets may be taken with or without food. Swallow the tablets whole with plenty of water.

Elecor is usually administered together with other medicines for heart failure, for example, beta-blockers. The usual initial dose is one 25 mg tablet once daily, increasing after approximately 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 levels should be measured before starting treatment with Elecor, during the first week, and one month after initiation of treatment or after any dose adjustment. Your doctor may adjust the dose based on your blood potassium levels.

If you have mild renal impairment, treatment should be initiated with one 25 mg tablet daily. If you have moderate renal impairment, treatment should be initiated with one 25 mg tablet every other day. These doses may be adjusted, as directed by your doctor, according to your blood potassium levels.

Elecor is not recommended in patients with severe renal disease.

No initial dose adjustment is required in patients with mild to moderate hepatic impairment. If you have any liver or kidney disease, you may require more frequent blood potassium monitoring (see also “Do not take Elecor”).

In elderly patients: no initial dose adjustment is required.

In children and adolescents: Elecor is not recommended.

If you take more Elecor than you should

If you take more Elecor than you should, inform your doctor or pharmacist immediately. If you have taken too much medicine, the most likely symptoms are low blood pressure (manifested as dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalaemia, high levels of potassium in the blood (manifested by muscle cramps, diarrhoea, nausea, dizziness or headache).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Elecor

If it is almost time for your next dose, skip the missed dose and take the next tablet at the scheduled time.

Otherwise, take the tablet as soon as you remember, provided that more than 12 hours remain before your next scheduled dose. Then continue taking your medicine as usual.

Do not take a double dose to make up for a missed dose.

If you stop taking Elecor

It is important to continue taking Elecor as directed, unless your doctor advises you to stop treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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, an uncommon adverse effect (affecting up to 1 in 100 people).

Other reported adverse effects include:

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

• elevated potassium levels in blood (these symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache)
• fainting
• dizziness
• elevated blood cholesterol levels
• insomnia (difficulty sleeping)
• headache
• heart discomfort, for example, irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhoea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasm
• increased levels of urea in blood
• elevated levels of creatinine in blood, which may indicate kidney problems

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

• infection
• eosinophilia (increase in certain white blood cells)
• low sodium levels in blood
• dehydration
• elevated levels of triglycerides (fats) in blood
• rapid heartbeat
• inflammation of the gallbladder
• drop in blood pressure that may cause dizziness upon standing
• thrombosis (blood clot) in the legs
• sore throat
• flatulence
• underactive thyroid
• increased blood glucose levels
• reduced sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in certain blood tests

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Elecor

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 stated on the container and outer packaging following EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Elecor

The active substance in Elecor film-coated tablets is eplerenone. Each tablet contains 50 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 yellow opadry coating of Elecor 50 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 Elecor and contents of the pack

Elecor 50 mg tablets are yellow film-coated tablets. They are marked with “NSR” above “50”.

Elecor 50 mg film-coated tablets are available in cartons with blisters containing 30, 50 or 200 tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

Manufacturer

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

Date of the most recent review of this leaflet: August 2022

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