Eplerenon Medreg

Leaflet accompanying the packaging: patient information

Eplerenon Medreg, 25 mg, film-coated tablets

Eplerenon Medreg, 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Eplerenon Medreg and what is it used for

Eplerenon Medreg 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, leading to heart failure.

Eplerenon Medreg is used to treat heart failure to prevent its worsening and reduce the number of hospitalizations in case of:

• recently experienced myocardial infarction - in combination with other medicines used in heart failure, or
• persistent, mild symptoms despite previous treatment.

2. Important information before taking Eplerenon Medreg

When not to take Eplerenon Medreg:

• if the patient is allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a high level 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 HIV protease inhibitors (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 or high blood pressure conditions (so-called ACE inhibitors in combination with angiotensin II receptor antagonists (AIIRA)).

Warnings and precautions

Before starting treatment with Eplerenon Medreg, the patient should discuss it with their doctor, pharmacist, or nurse.

• If the patient has kidney or liver disease (see also "When not to take Eplerenon Medreg"),
• if the patient is taking lithium salts (usually used to treat manic-depressive disorders, also known as bipolar disorders),
• if the patient is taking tacrolimus or cyclosporine (used to treat skin diseases, such as psoriasis or eczema, and to prevent rejection of a transplanted organ).

Children and adolescents

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

Eplerenon Medreg and other medicines

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

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (HIV protease inhibitors), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression) - these medicines slow down the metabolism of Eplerenon Medreg, thereby prolonging its effect on the body.
• Potassium-sparing diuretics and potassium supplements - these medicines increase the risk of high potassium levels in the blood.
• ACE inhibitors in combination with angiotensin II receptor antagonists (AIIRA), used to treat high blood pressure, heart disease, and certain kidney diseases - these medicines may increase the risk of high potassium levels in the blood.
• Lithium (usually used to treat manic-depressive disorders, also known as bipolar disorders) - concomitant use of lithium with diuretics and ACE inhibitors increased lithium levels in the blood, which could cause side effects such as loss of appetite, vision disturbances, fatigue, muscle weakness, and tremors.
• Cyclosporine or tacrolimus (used to treat skin diseases, such as psoriasis or eczema, and to prevent rejection of a transplanted organ) - these medicines may cause kidney function disorders 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 relieve pain, stiffness, and inflammation) - these medicines may cause kidney function disorders 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-adrenergic blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate diseases) - may cause a decrease in blood pressure and dizziness when changing body position to standing.
• Tricyclic antidepressants, such as amitriptyline or amoxapine (used to treat depression), antipsychotic medicines, also known as neuroleptics, such as chlorpromazine or haloperidol (used to treat mental disorders), amifostine (used in cancer chemotherapy), and baclofen (used in case of increased muscle tension) - these medicines may cause a decrease in blood pressure and dizziness when changing body position to standing.

These medicines may cause a decrease in blood pressure and dizziness when 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) - may weaken the blood pressure-lowering effect of Eplerenon Medreg.
• Digoxin (used to treat heart disease) - concomitant use with Eplerenon Medreg may increase digoxin levels in the blood.
• Warfarin (an anticoagulant) - caution should be exercised when using warfarin, as increased warfarin levels in the blood may disrupt the effect of Eplerenon Medreg on the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an HIV protease inhibitor), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart disease and high blood pressure) - slow down the metabolism of Eplerenon Medreg, thereby prolonging its effect 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) may accelerate the metabolism of Eplerenon Medreg, thereby weakening its effect.

Eplerenon Medreg with food and drink

Eplerenon Medreg 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. The effect of Eplerenon Medreg during pregnancy has not been evaluated in humans.

It is not known whether eplerenone passes into breast milk. The patient should consult their doctor whether to stop breastfeeding or stop taking the medicine.

Driving and using machines

After taking Eplerenon Medreg, dizziness may occur. In this case, the patient should not drive or operate machines.

Eplerenon Medreg contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Eplerenon Medreg contains sodium

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

3. How to take Eplerenon Medreg

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.

Eplerenon Medreg tablets can be taken with or without food. The tablets should be swallowed whole, with a large amount of water.

Eplerenon Medreg is usually taken with other medicines used in heart failure, such as beta-blockers. The usual initial dose is one 25 mg tablet once a day. After about 4 weeks, the doctor will recommend increasing the dose to 50 mg once a day (one 50 mg tablet or two 25 mg tablets). The maximum dose is 50 mg per day.

The doctor will recommend checking the potassium level in the blood before starting treatment with Eplerenon Medreg, within the first week, and after one month of treatment, as well as after changing the dose. Depending on the potassium level in the blood, the doctor may adjust the dose of the medicine.

If the patient has mild kidney disease, treatment should be started with one 25 mg tablet per day. If the patient has moderate kidney disease, treatment should be started with one 25 mg tablet every other day. The doctor may recommend adjusting the dose, taking into account the potassium level in the blood.

In patients with severe kidney disease, the use of Eplerenon Medreg is contraindicated.

In patients with mild or moderate liver disease, it is not necessary to adjust the initial dose. In case of liver or kidney disease, it may be necessary to check the potassium level in the blood more frequently (see also "When not to take Eplerenon Medreg").

Elderly patients: no dose adjustment is required. Children and adolescents: the use of Eplerenon Medreg is not recommended.

Taking a higher dose of Eplerenon Medreg than recommended

In case of taking a higher dose of Eplerenon Medreg than recommended, the patient should immediately contact their doctor or pharmacist. The most likely symptoms of overdose are low blood pressure (causing dizziness, dizziness, blurred vision, weakness, sudden loss of consciousness) and hyperkalemia (high potassium levels in the blood), causing muscle cramps, diarrhea, nausea, dizziness, or headache).

Missing a dose of Eplerenon Medreg

If it is almost time for the next dose, the patient should skip the missed dose and take the next one at the usual time.

In other cases, the patient should take the dose as soon as they remember, provided that it is more than 12 hours until the next dose. Then, the patient should return to their usual dosing schedule.

The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Eplerenon Medreg

It is important to take Eplerenon Medreg according to the recommendations, 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, Eplerenon Medreg can cause side effects, although not everybody gets them.

If any of the following symptoms occur, the patient should seek medical attention immediately:

• swelling of the face, tongue, or throat;
• difficulty swallowing;
• hives and difficulty breathing. These are symptoms of angioedema, a rare side effect (may occur in less than 1 in 100 people).

Other reported side effects include:

Common side effects(may occur in less than 1 in 10 people):

• high potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache);
• fainting;
• central dizziness;
• high cholesterol levels in the blood;
• insomnia (difficulty sleeping);
• headache;
• heart disorders, such as arrhythmias and heart failure;
• cough;
• constipation;
• low blood pressure;
• diarrhea;
• nausea;
• vomiting;
• kidney function disorders;
• rash;
• itching;
• back pain;
• weakness;
• muscle cramps;
• high urea levels in the blood;
• high creatinine levels in the blood, which may indicate kidney function disorders.

Uncommon side effects(may occur in less than 1 in 100 people):

• infection;
• eosinophilia (an increase in the number of one type of white blood cell);
• low sodium levels in the blood;
• dehydration;
• high triglyceride levels in the blood;
• rapid heart rate;
• gallbladder inflammation;
• decreased blood pressure, which may cause dizziness when changing body position to standing;
• thrombosis (blood clots) in the legs;
• sore throat;
• bloating;
• hypothyroidism;
• high glucose levels in the blood;
• decreased sensation of touch;
• 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 side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Reporting side effects can also be done to the marketing authorization holder.

5. How to store Eplerenon Medreg

The medicine should be stored out of sight and reach of children.

This medicine does not require 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 stated.

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 packaging and other information

What Eplerenon Medreg contains

The active substance of Eplerenon Medreg is eplerenone.

• Each tablet contains 25 mg or 50 mg of eplerenone.

The other ingredients are:

Core:

Lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, sodium lauryl sulfate, hypromellose (5 mPas), talc, and magnesium stearate.

Coating:

Opadry 13B58802 (White): HPMC 2910/hypromellose (6 mPas), titanium dioxide (E 171), macrogol 400, polysorbate 80.

What Eplerenon Medreg looks like and what the pack contains

• Eplerenon Medreg, 25 mg, film-coated tablets: White, biconvex, film-coated tablet in the shape of a rhombus (length 7.22 mm, width 6.55 mm, thickness 2.80 mm), with "E" embossed on one side and "25" on the other side.
• Eplerenon Medreg, 50 mg, film-coated tablets: White, biconvex, film-coated tablet in the shape of a rhombus (length 9.28 mm, width 8.26 mm, thickness 3.65 mm), with "E" embossed on one side and "50" on the other side.

Eplerenon Medreg, 25 mg, film-coated tablets, and Eplerenon Medreg, 50 mg, film-coated tablets are available in blisters made of aluminum/paper/polyester/PVC or blisters made of PVC/PVDC/aluminum, in a cardboard box.

Package sizes: 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, or 200 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Medreg s.r.o.

Na Florenci 2116/15

Nové Město

110 00 Prague 1

Czech Republic

tel.: (+420) 516 770 199

Importer:

Medis International a.s.

Průmyslová 961/16

747 23 Bolatice

Czech Republic

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

Czech Republic:

Eplerenon Medreg

Poland:

Eplerenon Medreg

Slovakia:

Eplerenon Medreg 25 mg

Eplerenon Medreg 50 mg

Date of last revision of the leaflet: 06/2024