Eplerenon Medical Vallei

Leaflet attached to the packaging: information for the user

Eplerenon Medical Valley, 25 mg, film-coated tablets

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

1. What is Eplerenon Medical Valley and what is it used for

Eplerenon Medical Valley 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.

Eplerenon Medical Valley is used to treat heart failure to prevent the worsening of the disease and reduce the number of hospitalizations in cases of:

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

2. Important information before taking Eplerenon Medical Valley

When not to take Eplerenon Medical Valley

• 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 levels of potassium in the blood (hyperkalemia);
• if the patient is taking medicines that remove excess fluid from the body (potassium-sparing diuretics) or potassium supplements;
• 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 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 diseases or high blood pressure (angiotensin-converting enzyme inhibitors - ACE in combination with angiotensin receptor antagonists - ARB).

Warnings and precautions

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

• if the patient has kidney or liver disease (see also "When not to take Eplerenon Medical Valley");
• 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 Medical Valley and other medicines

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

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (HIV medicines), clarithromycin, telithromycin (used to treat bacterial infections), and nefazodone (used to treat depression). These medicines slow down the metabolism of Eplerenon Medical Valley, thereby prolonging its effect on the body.
• Potassium-sparing diuretics (medicines that help remove excess fluid from the body) and potassium supplements. These medicines increase the risk of high potassium levels in the blood.
• Angiotensin-converting enzyme inhibitors (ACE) in combination with angiotensin receptor antagonists (ARB) (used to treat high blood pressure, heart disease, and certain kidney diseases), as these medicines may increase the risk of high potassium levels in the blood.

Tell your doctor about taking any of the following medicines:

• Lithium (used to treat manic-depressive disorders, also known as bipolar disorders). Taking 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 thus increase the risk of high potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs - painkillers, such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines may cause kidney function disorders and thus 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 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 to treat increased muscle tension). 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 Medical Valley.
• Digoxin (used to treat heart diseases). Taking digoxin with Eplerenon Medical Valley may increase digoxin levels in the blood.
• Warfarin (anticoagulant): caution should be exercised when taking warfarin, as increased warfarin levels in the blood may disrupt the effect of Eplerenon Medical Valley on the body.
• Erythromycin (used to treat bacterial infections), saquinavir (HIV medicine), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart diseases and high blood pressure) slow down the metabolism of Eplerenon Medical Valley, thereby prolonging its effect on the body.
• St. John's Wort (herbal medicinal product), rifampicin (medicine used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among other things, to treat epilepsy) may accelerate the metabolism of Eplerenon Medical Valley, thereby weakening its effect.

Eplerenon Medical Valley with food, drink, and alcohol

Eplerenon Medical Valley can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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 medicine. The effect of Eplerenon Medical Valley during pregnancy has not been evaluated in humans.

It is not known whether eplerenone passes into breast milk. Consult your doctor about whether to stop breastfeeding or stop taking the medicine.

Driving and using machines

After taking Eplerenon Medical Valley, dizziness may occur. In this case, do not drive vehicles or operate machinery.

Eplerenon Medical Valley contains lactose monohydrate

Eplerenon Medical Valley contains lactose monohydrate (a type of sugar). If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Eplerenon Medical Valley contains sodium

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

3. How to take Eplerenon Medical Valley

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Eplerenon Medical Valley tablets can be taken with or without food. Swallow the tablets whole with a glass of water.

Eplerenon Medical Valley is usually taken with other heart failure medicines, such as beta-blockers. The usual starting dose is one 25 mg tablet once daily, which is increased after about 4 weeks to 50 mg once daily (in the form of one 50 mg tablet or two 25 mg tablets). The maximum dose is 50 mg per day.

Before starting treatment with Eplerenon Medical Valley, and during the first week and month after starting treatment or changing the dose, potassium levels in the blood should be measured.

Your doctor may adjust the dose based on potassium levels in the blood.

If the patient has mild kidney disease, treatment should be started with one 25 mg tablet once daily. If the patient has 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 potassium levels in the blood.

Eplerenon Medical Valley should not be used in patients with severe kidney disease.

In patients with mild or moderate liver disease, it is not necessary to adjust the starting dose.

In cases of liver or kidney disease, it may be necessary to measure potassium levels in the blood more frequently (see also "When not to take Eplerenon Medical Valley").

Elderly patients: no dose adjustment is required in elderly patients.

Taking a higher dose of Eplerenon Medical Valley than recommended

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

Missing a dose of Eplerenon Medical Valley

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

Otherwise, take the dose as soon as you remember, provided that it is more than 12 hours before the next dose. Then take the medicine as usual.

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

Stopping treatment with Eplerenon Medical Valley

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

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

4. Possible side effects

Like all medicines, Eplerenon Medical Valley 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 up to 1 in 10 people):

• high potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headaches)
• dizziness
• fainting
• 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
• increased urea levels in the blood
• increased creatinine levels in the blood, which may indicate kidney function disorders

Uncommon side effects(may occur in up to 1 in 100 people):

• infection
• eosinophilia (an increase in the number of a type of white blood cell)
• dehydration
• high triglyceride levels in the blood
• low sodium levels in the blood
• rapid heart rate
• gallbladder inflammation
• decreased blood pressure, which may cause dizziness when changing body position to standing
• blood clots in the legs
• sore throat
• bloating
• hypothyroidism
• high blood sugar levels
• numbness
• 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 any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eplerenon Medical Valley

Keep the medicine out of the sight and reach of children.

There are no special precautions for storing the medicinal product.

Do not use this medicine after the expiry date stated on the carton and blister after "Expiry Date" or "EXP". The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your 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 Medical Valley contains

The active substance is eplerenone. Each film-coated tablet contains 25 mg or 50 mg of eplerenone.

The other ingredients are:

Core:

Lactose monohydrate

Microcrystalline cellulose (type 101)

Sodium carboxymethylcellulose

Hypromellose (type 2910)

Microcrystalline cellulose (type 102)

Sodium lauryl sulfate

Talc

Magnesium stearate

Coating:

Lactose monohydrate

Hypromellose (type 2910)

Titanium dioxide (E 171)

Macrogol 4000

What Eplerenon Medical Valley looks like and contents of the pack

Eplerenon Medical Valley 25 mg is a white or almost white, round, film-coated tablet, 6 mm in diameter, with the marking "CG3" on one side and smooth on the other.

Eplerenon Medical Valley 50 mg is a white or almost white, round, film-coated tablet, 8 mm in diameter, with the marking "CG4" on one side and smooth on the other.

The tablets are packaged in PVC/Aluminum blisters, in cardboard boxes containing 20, 30, 50, 90, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medical Valley Invest AB

Brädgårdsvägen 28

236 32 Höllviken

Sweden

Manufacturer/Importer

Laboratorios LICONSA, S.A.

Avenida Miralcampo 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Medical Valley Invest AB

Brädgårdsvägen 28

236 32 Höllviken

Sweden

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany:

Epleraxiro 25mg 50mg Filmtabletten

Poland:

Eplerenon Medical Valley

Date of last revision of the leaflet:05.2024