Eplerenon Medreg

Package Leaflet: Information for the Patient

Eplerenon Medreg, 25 mg, Film-Coated Tablets

Eplerenon Medreg, 50 mg, Film-Coated Tablets

Eplerenone

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed specifically for you. 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 package leaflet, inform your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 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. Package Contents and Other Information

1. What is Eplerenon Medreg and What is it Used For

Eplerenon Medreg belongs to a group of medications called selective aldosterone antagonists. These medications 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.

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

• recently experienced heart attack - in combination with other medications used for heart failure, or
• persistent, mild symptoms despite previous treatment.

2. Important Information Before Taking Eplerenon Medreg

When Not to Take Eplerenon Medreg:

• if you are allergic to eplerenone or any of the other ingredients of this medication (listed in section 6);
• if you have high levels of potassium in your blood (hyperkalemia);
• if you are taking medications that remove excess fluid from the body (potassium-sparing diuretics);
• if you have severe kidney disease;
• if you have severe liver disease;
• if you are taking antifungal medications (ketoconazole or itraconazole);
• if you are taking medications against HIV (nelfinavir or ritonavir);
• if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin);
• if you are taking nefazodone, used to treat depression;
• if you are taking medications used to treat certain heart conditions or high blood pressure (so-called ACE inhibitors in combination with angiotensin receptor antagonists (AIIRA)).

Warnings and Precautions

Before starting treatment with Eplerenon Medreg, discuss it with your doctor, pharmacist, or nurse.

• If you have kidney or liver disease (see also "When Not to Take Eplerenon Medreg"),
• if you are taking lithium salts (usually used to treat manic-depressive disorders, also known as bipolar disorders),
• if you are taking tacrolimus or cyclosporine (used to treat skin conditions 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 Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medications against HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression) - these medications slow down the metabolism of Eplerenon Medreg, thereby prolonging its effect on the body.
• Potassium-sparing diuretics (medications that help remove excess fluid from the body) and potassium supplements - these medications increase the risk of high levels of potassium in the blood.
• ACE inhibitors in combination with angiotensin receptor antagonists (AIIRA), used to treat high blood pressure, heart conditions, and certain kidney diseases - these medications may increase the risk of high levels of potassium in the blood.
• Lithium (usually used to treat manic-depressive disorders, also known as bipolar disorders) - concurrent 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 conditions such as psoriasis or eczema and to prevent rejection of a transplanted organ) - these medications may cause kidney function disorders and thereby increase the risk of high levels of potassium in the blood.
• Non-steroidal anti-inflammatory medications (NSAIDs - some pain medications, such as ibuprofen, used to relieve pain, stiffness, and inflammation) - these medications may cause kidney function disorders and thereby 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-adrenergic blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions) - 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 medications, also known as neuroleptics, such as chlorpromazine or haloperidol (used to treat mental disorders), amifostine (used in cancer chemotherapy), and baclofen (used in cases of increased muscle tension) - these medications may cause a decrease in blood pressure and dizziness when changing body position to standing.

These medications 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 conditions) - concurrent use with Eplerenon Medreg may increase digoxin levels in the blood.
• Warfarin (an anticoagulant medication) - 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 antiviral medication used to treat HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart conditions and high blood pressure) - slow down the metabolism of Eplerenon Medreg, thereby prolonging its effect on the body.
• St. John's Wort (a herbal medication), 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication. The effect of Eplerenon Medreg during pregnancy has not been evaluated in humans.

It is not known whether eplerenone passes into human milk. Consult your doctor whether to stop breastfeeding or stop taking the medication.

Driving and Operating Machines

After taking Eplerenon Medreg, dizziness may occur. In such cases, do not drive vehicles or operate machines.

Eplerenon Medreg Contains Lactose Monohydrate

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medication.

Eplerenon Medreg Contains Sodium

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

3. How to Take Eplerenon Medreg

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Eplerenon Medreg tablets can be taken with or without food. Swallow the tablets whole with a large amount of water.

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

Your doctor will recommend checking your potassium levels 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 your potassium levels, your doctor may adjust the dose of the medication.

If you have mild kidney disease, treatment should be started with one 25 mg tablet per day. If you have moderate kidney disease, treatment should be started with one 25 mg tablet every other day. Your doctor may recommend adjusting the dose, taking into account your potassium levels.

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 cases of liver or kidney disease, more frequent monitoring of potassium levels in the blood may be necessary (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 More Than the Recommended Dose of Eplerenon Medreg

If you have taken more than the recommended dose of Eplerenon Medreg, contact your doctor or pharmacist immediately. The most likely symptoms of overdose are low blood pressure (causing dizziness, dizziness, blurred vision, weakness, sudden loss of consciousness) and hyperkalemia (high levels of potassium in the blood), causing muscle cramps, diarrhea, nausea, dizziness, or headache).

Missing a Dose of Eplerenon Medreg

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

In other cases, take the dose as soon as you remember, provided that it is more than 12 hours until the next dose. Then, return to your regular dosing schedule.

Do not take a double dose to make up for a missed dose.

Stopping Treatment with Eplerenon Medreg

It is important to take Eplerenon Medreg as recommended, unless your doctor advises you to stop treatment.

If you have any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Eplerenon Medreg can cause side effects, although not everybody gets them. If you experience any of the following symptoms, seek medical help 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):

• increased potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache);
• fainting;
• central dizziness;
• increased 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;
• increased urea levels in the blood;
• increased 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 (increased levels of a type of white blood cell);
• low sodium levels in the blood;
• dehydration;
• increased triglyceride levels (fats) in the blood;
• rapid heart rate;
• gallbladder inflammation;
• decreased blood pressure, which may cause dizziness when changing body position to standing;
• blood clots (thrombosis) in the legs;
• sore throat;
• bloating;
• hypothyroidism;
• increased 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 you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 will help gather more information on the safety of this medication.

Side effects can also be reported to the marketing authorization holder.

5. How to Store Eplerenon Medreg

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the carton and blister after: EXP.

The expiration date refers to the last day of the specified month.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents 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.

Other ingredients are:

Tablet core:

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

Tablet 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 Package Contains

• Eplerenon Medreg, 25 mg, film-coated tablets: White, biconvex, rhomboid-shaped tablet (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, rhomboid-shaped tablet (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 of aluminum/paper/polyester/PVC or 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 Package Leaflet: 06/2024