Eplenocard

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Eplenocard, 25 mg, film-coated tablets

Eplenocard, 50 mg, film-coated tablets

(Eplerenone)

Read the 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Eplenocard and what is it used for

Eplenocard belongs to a group of medicines called selective aldosterone antagonists. These medicines block the action of aldosterone, a substance produced by the body that controls blood pressure and heart function. Increased levels of aldosterone can cause changes in the body that lead to heart failure. Eplenocard is used to treat heart failure to prevent the worsening of the disease and reduce the number of hospitalizations in cases of:

• 1. myocardial infarction - in combination with other heart failure medicines, or
• 2. persistent, mild symptoms despite ongoing treatment.

2. Important information before taking Eplenocard

When not to take Eplenocard:

• if the patient is allergic to the active substance 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 remove excess fluid from the body (potassium-sparing diuretics)
• if the patient has severe kidney disease
• if the patient has severe liver disease
• if the patient is taking antifungal medicines (ketoconazole or itraconazole)
• if the patient is taking anti-HIV medicines (ritonavir or nelfinavir)
• if the patient is taking antibiotics (clarithromycin or telithromycin)
• if the patient is taking nefazodone, used to treat depression
• if the patient is taking a combination of ACE inhibitors and angiotensin receptor blockers (used to treat high blood pressure, heart disease, and some kidney diseases), as these medicines may increase potassium levels in the blood.

Warnings and precautions

Before starting Eplenocard, the patient should discuss the following with their doctor or pharmacist:

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

Children and adolescents

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

Eplenocard and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines available without a prescription. The patient should not take Eplenocard with the following medicines (see "When not to take Eplenocard"): itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin, and nefazodone. These medicines prolong the half-life of Eplenocard, thereby extending its effect on the body.

• potassium-sparing diuretics and potassium supplements, as these may increase potassium levels in the blood
• ACE inhibitors and angiotensin receptor blockers (used to treat high blood pressure, heart disease, and some kidney diseases), as these may increase potassium levels in the blood

The patient should inform their doctor about the following medicines:

• lithium (used to treat manic-depressive disorders), as the combination of lithium and diuretics or ACE inhibitors may increase lithium levels in the blood, leading to side effects such as loss of appetite, vision disturbances, fatigue, muscle weakness, and tremors
• cyclosporine or tacrolimus (used to treat skin disorders and prevent rejection after organ transplantation), as these medicines may cause kidney dysfunction and increase potassium levels in the blood
• non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen), as these may cause kidney dysfunction and increase potassium levels in the blood
• trimethoprim (used to treat bacterial infections), which may increase potassium levels in the blood
• alpha-1 adrenergic blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate disorders), which may cause low blood pressure and dizziness when changing positions
• 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 muscle spasms). These medicines may cause low blood pressure and dizziness when changing positions.

Certain medicines may interact with Eplenocard, including:

• corticosteroids, such as hydrocortisone or prednisone (used to treat inflammatory conditions and certain skin disorders), and tetracosactide (used to diagnose and treat adrenal disorders), which may reduce the blood pressure-lowering effect of Eplenocard
• digoxin (used to treat heart conditions), as the combination with Eplenocard may increase digoxin levels in the blood
• warfarin (an anticoagulant), as increased warfarin levels in the blood may affect the efficacy of Eplenocard
• erythromycin (used to treat bacterial infections), saquinavir (an anti-HIV medicine), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart conditions and high blood pressure), which may prolong the half-life of Eplenocard and extend its effect on the body
• St. John's Wort (a herbal medicinal product), rifampicin (an antibiotic), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy, among other conditions), which may reduce the effect of Eplenocard

Eplenocard with food and drink

Eplenocard 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 Eplenocard in pregnant women. It is not known whether eplerenone passes into breast milk. The patient should consult their doctor about whether to stop breastfeeding or stop taking Eplenocard.

Driving and using machines

After taking Eplenocard, the patient may experience dizziness. In this case, they should not drive or operate machinery.

Eplenocard contains lactose monohydrate

Eplenocard contains lactose monohydrate (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

Eplenocard contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Eplenocard

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. Eplenocard tablets can be taken with or without food. The tablets should be swallowed whole with a large amount of water. Eplenocard is usually taken in combination with other heart failure medicines, such as beta blockers. The usual starting dose is one 25 mg tablet per day, which may be increased to 50 mg per day (as one 50 mg tablet or two 25 mg tablets) after about 4 weeks. The maximum dose is 50 mg per day.

Patients with kidney or liver impairment

If the patient has mild kidney impairment, they should start with a single dose of 25 mg per day. In cases of moderate kidney disease, the starting dose is 25 mg every other day. If the doctor recommends it, and depending on potassium levels in the blood, these doses may be adjusted. Eplenocard is not recommended for patients with severe kidney disease. In patients with mild to moderate liver impairment, no dose adjustment is necessary. However, more frequent monitoring of potassium levels in the blood may be required (see also "When not to take Eplenocard").

Elderly patients

No dose adjustment is necessary.

Use in children and adolescents

Eplenocard is not recommended for children and adolescents.

Overdose of Eplenocard

In case of overdose, the patient should immediately consult their doctor or pharmacist. The most likely symptoms of overdose are low blood pressure (causing dizziness, blurred vision, weakness, and fainting) and hyperkalemia (high potassium levels in the blood, causing muscle cramps, diarrhea, nausea, dizziness, or headache).

Missing a dose of Eplenocard

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 missed dose as soon as they remember, provided it is more than 12 hours before the next dose. The patient should then continue taking the medicine as usual. The patient should not take a double dose to make up for the missed dose.

Stopping Eplenocard treatment

It is important to take Eplenocard as prescribed, unless the doctor recommends stopping 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, Eplenocard can cause side effects, although not everybody gets them. The patient should seek medical attention immediatelyif they experience any of the following symptoms:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing. These are symptoms of angioedema, which occurs in less than 1 in 100 patients.

Other reported side effects include:

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

• high potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• fainting
• dizziness
• heart problems, such as irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• kidney problems
• 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 (an increase in a type of white blood cell)
• low sodium levels in the blood
• dehydration
• high levels of triglycerides (fats) in the blood
• fast heartbeat
• gallbladder inflammation
• low blood pressure, which may cause dizziness when changing positions
• blood clots in the legs
• sore throat
• bloating
• underactive thyroid
• high blood sugar levels
• reduced sensitivity to touch
• excessive sweating
• musculoskeletal pain
• general feeling of being unwell
• kidney inflammation
• breast enlargement in men
• changes in blood test results

Reporting side effects

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

5. How to store Eplenocard

The medicine should be stored out of sight and reach of children. There are no special storage instructions for the medicinal product. Do not use this medicine after the expiry date stated on the carton and blister after: Expiry date (EXP). The expiry date (EXP) refers to the last day of the month stated. 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 Eplenocard contains

• The active substance of Eplenocard is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose (E460), hypromellose (Benecel E3), sodium croscarmellose (type A), talc, magnesium stearate

The coating of the Eplenocard 25 mg and 50 mg film-coated tablets contains Opadry 02F220004(yellow): macrogol/PEG 6000, HPMC 2910/hypromellose 5 cP, talc (E553b), titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).

What Eplenocard looks like and contents of the pack

Eplenocard 25 mg tablets are yellow, round, biconvex tablets with "E25" engraved on one side. Eplenocard 50 mg tablets are yellow, round, biconvex tablets with "E50" engraved on one side. Eplenocard 25 mg and 50 mg film-coated tablets are available in PVC/Aluminum blisters containing 20, 28, 30, 50, 90, 100, and 200 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Pharmathen S.A.
6, Dervenakion str.
153 51 Pallini, Attiki
Greece
Pharmathen International SA
Sapes Industrial Park Block 5
69300 Rodopi
Greece
G.L.Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Date of last revision of the leaflet: