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, 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package 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 the patient has persistent, mild symptoms despite previous treatment.

• if the patient has had a heart attack recently, in combination with other medicines usually used to treat heart failure, or
• if the patient has 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).

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.
• ACE inhibitors and angiotensin receptor blockers (used to treat high blood pressure, heart conditions, 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, the lithium level in the blood can become too high, which can cause the following side effects: 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 problems, which can increase 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 problems, which can increase 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 position.
• 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 tone). These medicines can cause low blood pressure and dizziness when changing position.

after changing position.

• 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 conditions). The level of digoxin in the blood may increase when taken with Eleveon.
• Warfarin (an anticoagulant): caution should be exercised when taking warfarin, as increased warfarin levels in the blood can affect the action of Eleveon.
• 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 conditions 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 to treat epilepsy, among other conditions), 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 this happens, they should not drive or operate machinery. Eleveon contains lactose monohydrate(a type of sugar) and sodium. If the patient has been told they have an intolerance to some sugars, they should contact their doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Eleveon

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should ask 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 level 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 level.

Patients with kidney or liver disease

In patients with mild kidney disease, treatment starts with one 25 mg tablet per day. In patients with 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 level. Eleveon is not recommended for 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 the potassium level more frequently (see also "When not to take Eleveon").

Patients over 65 years

There is no need to change the starting dose.

Use in children and adolescents

Eleveon is not recommended for children and adolescents.

Overdose of Eleveon

If the patient takes more Eleveon than they should, they should contact their doctor or pharmacist immediately. The most likely symptoms that may occur after taking too much Eleveon are: low blood pressure (feeling faint, dizzy, 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).

Missed 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, the patient should take the dose as soon as they remember, provided that it is more than 12 hours 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 a 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 questions about their medicine, they should ask 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 problems

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

• infections,
• eosinophilia (increased levels 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 position,
• blood clots in the legs,
• sore throat,
• bloating,
• underactive thyroid,
• high levels of glucose in the blood,
• 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 those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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. Reporting side effects will help to gather more information on the safety of this medicine.

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 they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Eleveon contains

• The active substance is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.
• The other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, 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, Bucuresti, 032266, Romania

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

France: Eplerenone Zentiva, Greece, Poland, Slovakia: 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