Eleveon

Package leaflet: Information for the patient

Eleveon, 25 mg, film-coated tablets
Eleveon, 50 mg, film-coated tablets
Eplerenonum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Eleveon is and what it is 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 Eleveon is and what it is 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 regulates blood pressure and heart function. High levels of aldosterone may cause changes in the body leading to heart failure.
Eleveon is used in the treatment of heart failure to prevent worsening of heart failure and to reduce the risk of hospitalization when:

• the patient has recently suffered a heart attack, in combination with other medicines usually used in the treatment of heart failure, or
• the patient has persistent, mild symptoms despite current 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 potassium levels in the blood (hyperkalaemia),
• if the patient is taking diuretics that conserve potassium (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 antifungal medicines used to treat fungal infections (ketoconazole or itraconazole),
• if the patient is taking antiviral medicines used to treat HIV infections (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 simultaneously medicines used to treat certain heart conditions or high blood pressure (so-called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs)).

Warnings and precautions
Before starting Eleveon, discuss with your doctor or pharmacist:

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

Children and adolescents
The safety and efficacy of Eleveon in children and adolescents have not been established.

Eleveon and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, and any medicines the patient plans 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), because these medicines inhibit the breakdown of Eleveon, thereby prolonging its effect in the body.
• Potassium-sparing diuretics (medicines that help eliminate excess fluid from the body) and potassium supplements, because these medicines increase the risk of high potassium levels in the blood.
• Concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) (used to treat high blood pressure, heart diseases, or certain kidney diseases), because these medicines may increase the risk of excessively high potassium levels in the blood.
• Lithium (usually used in the treatment of bipolar disorder, also known as manic-depressive illness). It has been shown that when lithium is taken together with diuretics and ACE inhibitors (used to treat high blood pressure and heart diseases), lithium levels in the blood may rise excessively, which may cause the following adverse effects: loss of appetite, visual disturbances, fatigue, muscle weakness, muscle tremors.
• Cyclosporine or tacrolimus (used in the treatment of skin diseases such as psoriasis or eczema and to prevent organ rejection after transplantation). These medicines may cause kidney dysfunction and thereby increase the risk of high potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs – some painkillers, such as ibuprofen, used to treat pain, muscle stiffness, and inflammation). These medicines may cause kidney dysfunction and thereby 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-adrenergic blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions), may cause low blood pressure and dizziness upon changing to an upright position.
• Tricyclic antidepressants, such as amitriptyline or amoxapine (used to treat depression), antipsychotics (also called 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 may cause low blood pressure and dizziness upon changing to an upright position.
• Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammatory conditions and certain skin diseases) and tetracosactide (used mainly in the diagnosis and treatment of adrenal cortex disorders), may reduce the blood pressure-lowering effect of Eleveon.
• Digoxin (used to treat heart conditions). Blood digoxin levels may increase when Eleveon is taken concomitantly.
• Warfarin (an anticoagulant): Caution should be exercised when using warfarin, as increased warfarin levels in the blood may alter the effect of Eleveon on the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine used to treat HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart conditions and high blood pressure) inhibit the breakdown of Eleveon, thereby prolonging its effect in the body.
• St. John's wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, in epilepsy treatment) may increase the breakdown of Eleveon, thereby reducing its effect.

Taking Eleveon with food
Eleveon may be taken with food or independently of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Studies on the use of Eleveon during pregnancy have not been conducted.
It is not known whether eplerenone passes into human milk. A decision should be made together with the doctor whether to discontinue breastfeeding or to stop taking the medicine.

Driving and operating machinery
After taking Eleveon, the patient may experience dizziness. If such symptoms occur, driving or operating machinery is not allowed.

Eleveon contains monohydrate lactose (a type of sugar) and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before using this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Eleveon

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Eleveon tablets may be taken with or without food. Swallow the tablets whole with a large amount of water.
Eleveon is usually given together with other medicines used to treat heart failure, such as
beta-blockers. The usual starting dose is one 25 mg tablet once daily, increased after approximately 4 weeks to 50 mg once daily (one 50 mg tablet or two 25 mg tablets). The maximum daily dose is 50 mg.
Blood potassium levels should be measured before starting Eleveon, within the first week of treatment, and one month after starting treatment or after any dose adjustment. Your doctor may adjust the dose based on your blood potassium levels.

Patients with kidney or liver disease
In patients with mild kidney disease, treatment is started with one 25 mg tablet daily.
In patients with moderate kidney disease, treatment is started with a dose of 25 mg every other day.
These doses may be adjusted by the doctor based on blood potassium levels.
Use of Eleveon is not recommended in patients with severe kidney disease.
In patients with mild to moderate liver disease, no adjustment of the initial dose is necessary.
In patients with liver or kidney disease, more frequent monitoring of blood potassium levels may be required (see also section "When not to take Eleveon").

Elderly patients
No adjustment of the initial dose is necessary.

Use in children and adolescents
Eleveon is not recommended for use in children and adolescents.

If you take more Eleveon than you should
If you take more Eleveon than prescribed, contact your doctor or pharmacist immediately.
The most likely symptoms following an overdose include low blood pressure (manifesting as a feeling of emptiness in the head, dizziness, blurred vision, weakness, sudden loss of consciousness) or hyperkalaemia, i.e. high blood potassium levels (manifesting as muscle cramps, diarrhoea, nausea, dizziness, or headache).

If you forget to take Eleveon
If it is almost time for your next dose, skip the missed dose and take the next tablet at the usual time.
Otherwise, take the missed tablet as soon as you remember, provided that more than 12 hours remain before the next scheduled dose. Then continue taking the medicine as before.
Do not take a double dose to make up for a missed tablet.

Stopping Eleveon
It is important to take Eleveon exactly as prescribed, unless your doctor advises you to stop treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, seek immediate medical attention:

• swelling of the face, tongue or throat,
• difficulty swallowing,
• urticaria and breathing difficulties.

These are symptoms of angioedema, which is an uncommon adverse reaction (occurring in less than 1 in 100 patients).

Other reported adverse reactions include:
Common adverse reactions (may occur in less than 1 in 10 patients):

• increased blood potassium levels (symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache),
• dizziness,
• fainting,
• increased blood cholesterol levels,
• insomnia (difficulty falling asleep),
• headache,
• heart-related problems such as palpitations and heart failure,
• cough,
• constipation,
• low blood pressure,
• diarrhoea,
• nausea,
• vomiting,
• kidney function abnormalities,
• rash, itching,
• back pain,
• fatigue,
• muscle cramps,
• increased blood urea levels,
• increased blood creatinine levels, which may indicate impaired kidney function.

Uncommon adverse reactions (may occur in less than 1 in 100 patients):

• infections,
• eosinophilia (increased levels of certain white blood cells),
• dehydration,
• increased blood triglyceride (fat) levels,
• decreased blood sodium levels,
• rapid heartbeat,
• cholecystitis (inflammation of the gallbladder),
• low blood pressure upon standing, which may cause dizziness when changing position to standing,
• deep vein thrombosis (blood clots) in the lower limbs,
• sore throat,
• bloating,
• hypothyroidism,
• increased blood glucose levels,
• hypoglycaemia,
• excessive sweating,
• musculoskeletal pain,
• malaise,
• nephritis (kidney inflammation),
• breast enlargement in men,
• changes in certain blood test results.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions may also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Eleveon

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 carton and blister after "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures 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.
• Other ingredients are: tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate; tablet coating: Opadry Yellow 13B82402 (hypromellose, titanium dioxide (E 171), polyethylene glycol 400, polysorbate 80, iron oxide yellow (E 172)).

What Eleveon looks like and contents of the pack
Eleveon 25 mg: yellow coated tablets.
Eleveon 50 mg: yellow coated tablets.
Eleveon 25 mg and 50 mg is available in blister packs containing 20, 30, or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00