Eleveon

Package Leaflet: Information for the Patient

Eleveon, 25 mg, film-coated tablets

Eleveon, 50 mg, film-coated tablets

Eplerenone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Eleveon and what is it used for

Eleveon belongs to a group of medicines called selective aldosterone antagonists. These medicines block the action of aldosterone, a substance produced in the body that controls blood pressure and heart function. High levels of aldosterone can cause changes in the body that lead to heart failure. Eleveon is used to treat heart failure to prevent worsening of heart failure and reduce the risk of hospitalization if the patient has recently had a heart attack, in combination with other medicines usually used to treat heart failure, or if they have persistent, mild symptoms despite previous treatment.

• if they have recently had a heart attack, in combination with other medicines usually used to treat heart failure, or
• if they have persistent, mild symptoms despite previous treatment.

2. Important information before taking Eleveon

When not to take Eleveon:

• if the patient is allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6),
• if the patient has high levels of potassium in the blood (hyperkalemia),
• if the patient is taking medicines that help remove excess fluid from the body (potassium-sparing diuretics) or "salt tablets" (potassium supplements),
• if the patient has severe kidney disease,
• if the patient has severe liver disease,
• if the patient is taking medicines used to treat fungal infections (ketoconazole or itraconazole),
• if the patient is taking antiviral medicines used to treat HIV infection (nelfinavir or ritonavir),
• if the patient is taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin),
• if the patient is taking nefazodone used to treat depression,
• if the patient is taking medicines used to treat certain heart conditions or high blood pressure (so-called ACE inhibitors and angiotensin receptor blockers (ARBs)).

Warnings and precautions

Before starting treatment with Eleveon, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney or liver disease (see also "When not to take Eleveon"),
• if the patient is taking lithium (usually used to treat manic-depressive disorders, also known as bipolar affective disorders),
• if the patient is taking tacrolimus or cyclosporin (used to treat skin diseases, such as psoriasis or eczema, and to prevent organ rejection after transplantation).

Children and adolescents

No studies have been conducted on the safety and efficacy of Eleveon in children and adolescents.

Eleveon and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines used to treat HIV infection), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines can inhibit the breakdown of Eleveon, thereby prolonging its action on the body.
• Potassium-sparing diuretics and potassium supplements, as these medicines can increase the risk of high levels of potassium in the blood.
• Concomitant use of ACE inhibitors and ARBs (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medicines can increase the risk of high levels of potassium in the blood.
• Lithium (used to treat manic-depressive disorders, also known as bipolar affective disorders). It has been shown that when lithium is taken with diuretics and ACE inhibitors, blood lithium levels can rise excessively, leading to side effects such as loss of appetite, vision disturbances, fatigue, muscle weakness, and tremors.
• Cyclosporin or tacrolimus (used to treat skin diseases, such as psoriasis or eczema, and to prevent organ rejection after transplantation). These medicines can cause kidney function disorders, thereby increasing the risk of high levels of potassium in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs - some painkillers, such as ibuprofen, used to treat pain, stiffness, and inflammation). These medicines can cause kidney function disorders, thereby increasing the risk of high levels of potassium in the blood.
• Trimethoprim (used to treat bacterial infections) may increase the risk of high levels of potassium in the blood.
• Alpha-1-adrenergic blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate diseases), can cause low blood pressure and dizziness when changing body position to standing.
• Tricyclic antidepressants, such as amitriptyline or amoxapine (used to treat depression), antipsychotics (also known as neuroleptics), such as chlorpromazine or haloperidol (used to treat mental disorders), amifostine (used in cancer chemotherapy), and baclofen (used to treat increased muscle tension). These medicines can cause low blood pressure and dizziness when changing body position to standing.

after changing body position to standing.

• Corticosteroids, such as hydrocortisone or prednisone (used to treat inflammatory conditions and certain skin diseases), and tetracosactide (mainly used to diagnose and treat adrenal cortex disorders), can reduce the blood pressure-lowering effect of Eleveon.
• Digoxin (used to treat heart disease). Digoxin blood levels may increase when taken with Eleveon.
• Warfarin (an anticoagulant): caution should be exercised when taking warfarin, as increased warfarin blood levels can alter the effect of Eleveon on the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine used to treat HIV infection), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart disease and high blood pressure), can inhibit the breakdown of Eleveon, thereby prolonging its action on the body.
• St. John's Wort (a herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among other things, to treat epilepsy), can increase the breakdown of Eleveon, thereby reducing its effect.

Taking Eleveon with food

Eleveon can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. No studies have been conducted on the use of Eleveon in pregnant women. It is not known whether eplerenone passes into breast milk. The patient should discuss with their doctor whether to stop breastfeeding or stop taking Eleveon.

Driving and using machines

After taking Eleveon, the patient may feel dizzy. If such symptoms occur, they should not drive or operate machinery. Eleveon contains lactose monohydrate(a type of sugar) and sodium. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Eleveon

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. Eleveon tablets can be taken with or without food. The tablets should be swallowed whole, with a large amount of water. Eleveon is usually given with other medicines used to treat heart failure, such as beta-blockers. The usual starting dose is one 25 mg tablet once a day, increased after about 4 weeks to 50 mg once a day (one 50 mg tablet or two 25 mg tablets). The maximum daily dose is 50 mg. The patient's potassium blood levels should be checked before starting treatment with Eleveon, within the first week of treatment, and after one month of treatment or after changing the dose. The doctor may adjust the dose based on the potassium blood levels.

Patients with kidney or liver disease

In patients with mild kidney disease, treatment starts with one 25 mg tablet per day. In cases of moderate kidney disease, treatment starts with a dose of 25 mg every other day. These doses may be adjusted by the doctor based on the potassium blood levels. The use of Eleveon is not recommended in patients with severe kidney disease. In patients with mild to moderate liver disease, there is no need to adjust the starting dose. In patients with liver or kidney disease, it may be necessary to check potassium blood levels more frequently (see also "When not to take Eleveon").

Patients over 65 years of age

There is no need to change the starting dose.

Use in children and adolescents

Eleveon is not recommended for children and adolescents.

Taking more than the recommended dose of Eleveon

If the patient takes more than the recommended dose of Eleveon, they should immediately consult their doctor or pharmacist. The most likely symptoms that may occur after taking too much Eleveon are: low blood pressure (feeling of emptiness in the head, dizziness, blurred vision, weakness, sudden loss of consciousness) or hyperkalemia, i.e., high levels of potassium in the blood (muscle cramps, diarrhea, nausea, dizziness, or headache).

Missing a dose of Eleveon

If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the usual time. Otherwise, they should take the dose as soon as they remember, provided that there are more than 12 hours left before the next planned dose. Then, the patient should continue taking the medicine as before. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Eleveon

It is important to take Eleveon as prescribed, unless the doctor advises the patient to stop treatment. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Eleveon can cause side effects, although not everybody gets them. If the patient experiences any of the following symptoms, they should seek medical help immediately:

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing. These are symptoms of angioedema, which is an uncommon side effect (occurring in less than 1 in 100 patients).

Other reported side effects include:

Common side effects(may affect up to 1 in 10 patients):

• 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,
• insomnia (difficulty sleeping),
• headache,
• heart problems, such as irregular heartbeat and heart failure,
• cough,
• constipation,
• low blood pressure,
• diarrhea,
• nausea,
• vomiting,
• abnormal kidney function,
• rash, itching,
• back pain,
• weakness,
• muscle cramps,
• high levels of urea in the blood,
• high levels of creatinine in the blood, which may indicate kidney function disorders

Uncommon side effects(may affect up to 1 in 100 patients):

• infections,
• eosinophilia (an increase in the number of certain white blood cells),
• dehydration,
• high levels of triglycerides (fats) in the blood,
• low levels of sodium in the blood,
• rapid heartbeat,
• gallbladder inflammation,
• low blood pressure, which can cause dizziness when changing body position to standing,
• blood clots in the legs,
• sore throat,
• bloating,
• underactive thyroid,
• high blood sugar levels,
• numbness,
• increased sweating,
• musculoskeletal pain,
• general feeling of being unwell,
• kidney inflammation,
• breast enlargement in men,
• changes in some blood test results.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products. Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, more information can be gathered on the safety of the medicine.

• Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

5. How to store Eleveon

The medicine should be stored out of 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 carton and blister after "EXP". The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Eleveon contains

• The active substance of Eleveon is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.
• The other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hypromellose, sodium lauryl sulfate, and magnesium stearate; tablet coating: Opadry Yellow 13B82402 (hypromellose, titanium dioxide (E 171), macrogol 400, polysorbate 80, yellow iron oxide (E 172)).

What Eleveon looks like and contents of the pack

Eleveon, 25 mg: yellow film-coated tablets. Eleveon, 50 mg: yellow film-coated tablets. Eleveon, 25 mg and 50 mg, is available in blisters containing 20, 30, or 90 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Zentiva S.A., B-dul. Theodor Pallady nr.50, sector 3, 032266, Bucharest, Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France: Eplerenone Zentiva, Greece, Poland, Slovak Republic: Eleveon, Germany: Eplerenon Zentiva, United Kingdom: Eplerenone

For further information on this medicine, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, tel.: +48 22 375 92 00, Date of last revision of the leaflet:April 2024