Eplerenon Medical Vallei

Package Leaflet: Information for the User

Eplerenon Medical Valley, 25 mg, Film-Coated Tablets

Eplerenon Medical Valley, 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you only. 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, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 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. Package Contents and Other Information

1. What is Eplerenon Medical Valley and What is it Used For

Eplerenon Medical Valley 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 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 medications used to treat heart failure, or
• 2. persistent, mild symptoms despite ongoing treatment.

2. Important Information Before Taking Eplerenon Medical Valley

When Not to Take Eplerenon Medical Valley

• 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) or potassium supplements;
• 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 for 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 (angiotensin-converting enzyme inhibitors (ACE) in combination with angiotensin receptor blockers (ARB)).

Warnings and Precautions

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

• if you have kidney or liver disease (see also section "When Not to Take Eplerenon Medical Valley");
• 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 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 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.

• Ketoconazole or itraconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medications used to treat HIV infection), clarithromycin, telithromycin (used to treat bacterial infections), and nefazodone (used to treat depression). These medications slow down the metabolism of Eplerenon Medical Valley, 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.
• Angiotensin-converting enzyme inhibitors (ACE) in combination with angiotensin receptor blockers (ARB) (used to treat high blood pressure, heart disease, and certain kidney diseases), as these medications may increase the risk of high levels of potassium in the blood.

Tell your doctor about taking any of the following medications:

• 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 may 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 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 - 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-1-adrenergic blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate diseases), may cause decreased 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 to treat increased muscle tone). These medications may cause decreased 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 disease). Taking digoxin with Eplerenon Medical Valley may increase digoxin levels in the blood.
• Warfarin (an anticoagulant medication): caution should be exercised when taking warfarin, as increased warfarin levels in the blood may affect the action of Eplerenon Medical Valley.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medication used to treat HIV infection), 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 Medical Valley, thereby prolonging its effect on the body.
• St. John's Wort (a herbal medicinal product), rifampicin (an antibiotic used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy, among other conditions), 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, ask your doctor or pharmacist for advice before taking this medication. The action of Eplerenon Medical Valley during pregnancy has not been evaluated in humans.

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

Driving and Using Machines

After taking Eplerenon Medical Valley, dizziness may occur. In this case, do not drive 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, contact your doctor before taking the medication.

Eplerenon Medical Valley Contains Sodium

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

3. How to Take Eplerenon Medical Valley

Always take this medication exactly as your doctor has told you. If you are not sure, ask 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 in combination with other medications used to treat heart failure, 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 one month after starting treatment or changing the dose, your potassium levels in the blood should be checked.

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

If you have mild kidney disease, treatment should be started with one 25 mg tablet once daily. 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 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 check 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.

What to Do if You Take More Eplerenon Medical Valley Than You Should

If you take more Eplerenon Medical Valley than you should, contact your doctor or pharmacist immediately. The most likely symptoms of overdose are: low blood pressure (causing 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).

What to Do if You Miss a Dose of Eplerenon Medical Valley

If it is almost time for your 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 your next dose. Then take your medication as you normally would.

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

What to Do if You Stop Taking Eplerenon Medical Valley

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

If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Eplerenon Medical Valley can cause side effects, although not everybody gets them.

If you experience any of the following symptoms:

Seek Medical Attention Immediately

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

Other reported side effects include:

Common Side Effects(may affect up to 1 in 10 people):

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

Uncommon Side Effects(may affect up to 1 in 100 people):

• infection
• eosinophilia (increased levels of a type of white blood cell)
• dehydration
• high levels of triglycerides (fats) in the blood
• low levels of sodium 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 levels of glucose in the blood
• numbness or tingling
• 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, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 medication.

5. How to Store Eplerenon Medical Valley

Keep this medication out of the sight and reach of children.

No special precautions for storage are required.

Do not use this medication after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that 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 Medical Valley Contains

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

The other ingredients are:

Tablet core:

Lactose monohydrate

Microcrystalline cellulose (type 101)

Sodium croscarmellose

Hypromellose (type 2910)

Microcrystalline cellulose (type 102)

Sodium lauryl sulfate

Talc

Magnesium stearate

Tablet coating:

Lactose monohydrate

Hypromellose (type 2910)

Titanium dioxide (E 171)

Macrogol 4000

What Eplerenon Medical Valley Looks Like and Contents of the Package

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 a smooth surface 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 a smooth surface 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 Medication 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 Package Leaflet:05.2024