EPLERENONUM 50 mg/40 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Eplerenone + Furosemide LEK-AM, 25 mg + 40 mg, Tablets
3. Eplerenone + Furosemide LEK-AM, 50 mg + 40 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
4. What is Eplerenone + Furosemide LEK-AM and what is it used for
5. Important information before taking Eplerenone + Furosemide LEK-AM
   1. When not to take Eplerenone + Furosemide LEK-AM:
   2. Warnings and precautions
   3. Children and adolescents
   4. Eplerenone + Furosemide LEK-AM and other medicines

Package Leaflet: Information for the Patient

Eplerenone + Furosemide LEK-AM, 25 mg + 40 mg, Tablets

Eplerenone + Furosemide LEK-AM, 50 mg + 40 mg, Tablets

Eplerenone + Furosemide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Eplerenone + Furosemide LEK-AM and what is it used for

Eplerenone + Furosemide LEK-AM contains two active substances: eplerenone and furosemide.

• Eplerenone 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 lead to changes in the body that result in heart failure.
• Furosemide belongs to a group of medicines called diuretics, which increase the amount of urine excreted by the kidneys, helping to remove excess fluids from the body. Diuretics are also known as water pills.

Eplerenone + Furosemide LEK-AM is used as replacement therapy in adult patients who are already taking furosemide and eplerenone in doses equivalent to those in the combination product Eplerenone + Furosemide LEK-AM, to reduce the risk of mortality and morbidity due to cardiovascular events in patients with stable heart failure with left ventricular dysfunction, left ventricular ejection fraction ≤40%, and clinical signs of heart failure (edema) after a recent myocardial infarction.

2. Important information before taking Eplerenone + Furosemide LEK-AM

When not to take Eplerenone + Furosemide LEK-AM:

• if the patient is allergic to eplerenone, furosemide, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to amiloride, sulfonamides, or sulfonamide derivatives, such as sulfadiazine or cotrimoxazole,
• if the patient has high levels of potassium in the blood (hyperkalemia),
• if the patient has severe kidney disease,
• if the patient has severe liver disease,
• if the patient is taking potassium-sparing diuretics,
• if the patient is taking antifungal medicines (ketoconazole or itraconazole),
• if the patient is taking anti-HIV medicines (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 in combination with angiotensin II receptor antagonists),
• if the patient has reduced intravascular volume or is dehydrated (with or without low blood pressure),
• if the patient is unable to urinate,
• if the patient has kidney failure - in some types of kidney failure, this medicine can still be taken, but the doctor will decide,
• if the patient has severe liver disease with brain disorders (hepatic encephalopathy),
• if the patient has pre-coma and coma states associated with liver cirrhosis,
• if the patient has electrolyte deficiencies (e.g., low potassium or sodium levels in the blood, as shown by blood tests),
• if the patient has a condition called Addison's disease, which can cause fatigue and weakness,
• if the patient is taking other medicines that change potassium levels in the blood (see "Eplerenone + Furosemide LEK-AM and other medicines"),
• digitalis poisoning,
• porphyria,
• if the patient is breastfeeding (see "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Before starting treatment with Eplerenone + Furosemide LEK-AM, the patient should discuss the following with their doctor, pharmacist, or nurse:

• if the patient has kidney or liver disease (see also "When not to take Eplerenone + Furosemide LEK-AM"),
• 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 cyclosporin (used to treat skin diseases, such as psoriasis or eczema, and to prevent rejection of a transplanted organ),
• if the patient is 65 years or older,
• if the patient has difficulty urinating,
• if the patient has diabetes (high blood sugar levels),
• if the patient is pregnant,
• if the patient has gout, liver or kidney disorders,
• if the patient has low blood pressure, it is necessary to regularly check electrolyte levels and adjust the dose accordingly, and also, if the patient experiences dizziness when standing up,
• if the patient has low protein levels in the blood (hypoproteinemia),
• if the patient is taking risperidone,
• if the patient has prostate disorders,
• if the patient feels dizzy or is dehydrated - such symptoms may occur if the patient has lost a lot of fluids due to vomiting, diarrhea, or frequent urination, and also if the patient has difficulty drinking or eating,
• if the patient will be taking NSAIDs,
• if the patient will undergo a glucose tolerance test,
• if the patient is taking other diuretics,
• if the patient has systemic lupus erythematosus (an autoimmune disease that attacks the skin, bones, joints, and internal organs),
• if the patient is elderly, taking other medicines that may lower blood pressure, or has other conditions that may increase the risk of low blood pressure.

If the patient is unsure whether any of the above conditions apply to them, they should consult their doctor or pharmacist before taking Eplerenone + Furosemide LEK-AM.

Children and adolescents

The safety and efficacy of eplerenone in children and adolescents have not been established, so Eplerenone + Furosemide LEK-AM should not be used in this patient group.

Eplerenone + Furosemide LEK-AM 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. Eplerenone + Furosemide LEK-AM may affect the action of the following medicines, and these medicines may also affect the action of Eplerenone + Furosemide LEK-AM:

• itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (anti-HIV medicines), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression) - these medicines slow down the metabolism of Eplerenone + Furosemide LEK-AM, 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 (such as ramipril, enalapril, perindopril) 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) - concurrent use of lithium with diuretics and ACE inhibitors has increased lithium levels in the blood, leading to side effects such as loss of appetite, vision disturbances, fatigue, muscle weakness, and tremors.

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