Package Leaflet: Information for the Patient

Eplerenona Krka 25 mg Film-Coated Tablets

Eplerenona Krka 50 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine.It contains important information for you.

• Keepthis leaflet, as you may need to read it again.
• Ifyou have any further questions, ask your doctor or pharmacist.
• Thismedicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• Ifyou experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.See section4.

Eplerenona Krka belongs to a group of medications known as selective aldosterone blockers. These blocking agents inhibit the action of aldosterone, a substance produced by the body, which controls blood pressure and cardiac function. Elevated levels of aldosterone can produce changes in the body that may lead to heart failure.

Eplerenona Krka is used to treat heart failure to prevent worsening and reduce hospitalization if:

you had a recent myocardial infarction, in combination with other medications used to treat your heart failure, or you have persistent mild symptoms, despite the treatment you have been receiving so far.

Do not takeEplerenona Krka

• if you areallergic to eplerenona or to any of the other ingredients of thismedication (listed in section6).
• if you have high levels of potassium in your blood (hyperkalemia)
• if you are taking medications that help your body get rid of excessfluids (potassium-sparing diuretics)
• if you have severe kidney disease
• if you have severe liver disease
• if you are taking medications used to treat fungal infections(ketoconazol or itraconazol)
• if you are taking antiviral medications used to treat HIV infections(nelfinavir or ritonavir)
• if you are taking antibiotics used to treat bacterial infections(claritromicina or telitromicina)
• if you are taking nefazodona to treat depression
• if you are taking medications used to treat certain heart or high blood pressure conditions (such as ACE inhibitors and angiotensin receptor blockers) at the same time.

Warnings and precautions

Consult your doctor or pharmacist before starting to take eplerenona:

• if you have kidney or liver disease (also see“Do not take Eplerenona Krka”)
• if you are taking lithium (usually used to treat manic-depressive disorder, also known as bipolar disorder)
• if you are taking tacrolimus or ciclosporina (used to treat skin conditions such as psoriasis or eczema and to prevent organ rejection)

Children and adolescents

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

Other medications and Eplerenona Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• Itraconazol or ketoconazol (used to treat fungal infections), ritonavir, nelfinavir (antiviral medications for HIV), claritromicina, telitromicina (used to treat bacterial infections) or nefazodona (used to treat depression), as these medications reduce the metabolism ofeplerenona, and therefore prolong its effect in the body.
• Diuretics that spare potassium (medications that help your body get rid of excess fluids) or potassium supplements (salt tablets) as these medications increase the risk of high potassium levels in the blood.
• ACE inhibitors and angiotensin receptor blockers (used to treat high blood pressure, heart disease, or certain kidney diseases) at the same time, as these medications may increase the risk of high potassium levels in the blood.

• Lithium (usually used to treat manic-depressive disorder, also known as bipolar disorder). The use of lithium with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) has been shown to cause excessively high levels of lithium in the blood, which may cause the following adverse reactions: loss of appetite, vision changes, fatigue, muscle weakness, and muscle cramps.
• Ciclosporina or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent organ rejection). These medications may cause kidney problems and therefore increase the risk of high potassium levels in the blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs – certain pain relievers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medications may cause kidney problems and therefore increase the risk of high potassium levels in the blood.
• Trimetoprim (used to treat bacterial infections) may increase the risk of high potassium levels in the blood.
• Alpha-1 blockers, such as prazosina or alfuzosina (used to treat high blood pressure and certain prostate diseases) may cause a decrease in blood pressure and dizziness when standing up.
• Tricyclic antidepressants, such as amitriptilina or amoxapina (used to treat depression), antipsychotics (also known as neuroleptics) such as clorpromazina or haloperidol (used to treat psychiatric disorders), amifostina (used during cancer chemotherapy) and baclofeno (used to treat muscle spasms). These medications may cause a decrease in blood pressure and dizziness when standing up.
• Glucocorticoids, such as hidrocortisona or prednisona (used to treat inflammation and certain skin conditions) and tetracosactida (used primarily to diagnose and treat adrenal gland disorders) may reduce the blood pressure-lowering effect of Eplerenona Krka.
• Digoxina (used to treat heart conditions). The levels of digoxina in the blood may increase when taken with Eplerenona Krka.
• Warfarina (an anticoagulant medication): Caution is required when administering warfarina doses because high levels of warfarina in the blood may cause changes in the effect of Eplerenona Krka on the body.
• Eritromicina (used to treat bacterial infections), saquinavir (antiviral medication for HIV), fluconazol (used to treat fungal infections), amiodarona, diltiazem and verapamilo (used to treat heart conditions and high blood pressure) reduce the metabolism of eplerenona, prolonging its effect in the body.
• St. John's Wort (herbal remedy), rifampicina (used to treat bacterial infections), carbamazepina, phenitoína and phenobarbital (used, among other things, to treat epilepsy) may increase the metabolism of Eplerenona Krka and therefore reduce its effect.

Taking Eplerenona Krka with food and drinks

Eplerenona Krka can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacistbefore using anymedication. Eplerenona Krka has not been evaluated in humans during pregnancy.

The elimination of eplerenona in breast milk is unknown. Your doctor will decide with you whether to stop breastfeeding or suspend treatment.

Driving and operating machinery

After taking Eplerenona Krka, you may feel dizzy. If this happens, do not drive or operate machinery.

Eplerenona Krka contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructionsof this medication indicated by your doctor or pharmacist.In case of doubt,consult your doctor or pharmacist again.

Eplerenona Krka tablets canbe taken with food or on an empty stomach. Swallow the tablets wholewith plenty of water.

Eplerenona Krka is usually administeredalong with other medications for heart failure, for example, beta-blockers. The recommended initial dose is one 25mg tablet once a day, increasing after 4weeks to 50mg daily (one 50mg tablet or two 25mg tablets). The maximum dosage regimen is50mg per day.

It is necessary to measure the levels ofpotassium in the blood before starting treatment with Eplerenona Krka, duringthe first week and a month after starting treatment or after a changein the dose. Your doctor may adjust the dose based on your potassium levels in the blood.

If you have mild renal insufficiency,you should start treatment with one 25mg tablet per day, and if you have moderate renal insufficiency, you should start treatment with one 25mg tablet every other day. These doses may be adjusted, if your doctor indicates, and in accordance with your potassium blood levels.

Eplerenona Krka is not recommendedin patients with severe kidney disease.

No initial dose adjustment is necessaryin patients with mild to moderate liver insufficiency. If you have liver or kidney problems, you may need to have your potassium blood levels checked more frequently (see also “Do not take Eplerenona Krka”).

In elderly patients:No initial dose adjustment is required.

Use in children and adolescents

In children and adolescents, Eplerenona Krkais not recommended.

If you take more Eplerenona Krka than you should

If you take more Eplerenona Krka thanyou should, consult your doctor or pharmacist immediately. If you have takentoo much medication, the most likely symptoms will be low blood pressure(manifested as dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalemia, high levels of potassium in the blood (manifested by muscle cramps, diarrhea, nausea, dizziness, or headache).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Eplerenona Krka

If it is almost time to take the next tablet, skip the dose you forgot and take the next tablet when it is due.

Otherwise, take the tablet as soon as you remember, as long as more than 12 hours have passed until the time to take the next tablet. Resume your medication as usual.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eplerenona Krka

It is essential to continue taking Eplerenona Krka as instructed, unless your doctor tells you to stop treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience any of the following:

Seek immediate medical attention

• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Blisters and difficulty breathing

These are symptoms of angioneurotic edema, a rare side effect (which can affect up to 1 in 100 people).

Other reported side effects include:

Frequent(may affectup to1 in 10 people):

• Elevated potassium levels in the blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• Dizziness
• Fainting
• High cholesterol levels in the blood
• Insomnia (difficulty sleeping)
• Headache
• Cardiac discomfort, for example, irregular heartbeats and heart failure
• Cough
• Constipation
• Low blood pressure
• Diarrhea
• Nausea
• Vomiting
• Abnormal kidney function
• Rash
• Itching
• Back pain
• Weakness
• Muscle spasms
• Increased urea levels in the blood
• Elevated creatinine levels in the blood that may indicate kidney problems.

Rare(may affectup to1 in 100 people):

• Infection
• Eosinophilia (increase in certain white blood cells)
• Dehydration
• High triglyceride levels (fats) in the blood
• Low sodium levels in the blood
• Fast heartbeats
• Bile duct inflammation
• Low blood pressure that may cause dizziness when standing up
• Thrombosis (blood clot) in the legs
• Sore throat
• Flatulence
• Underactive thyroid
• Increased blood glucose
• Decreased sense of touch
• Increased sweating
• Musculoskeletal pain
• General discomfort
• Kidney inflammation
• Enlarged breasts in men
• Changes in certain blood tests.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister after the abbreviation CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Eplerenona Krka

• The active ingredient is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.

• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate, and sodium lauryl sulfate in the core of the tablets, and hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80, and iron oxide yellow (E172) in the pellicular coating. See section 2 “Eplerenona Krka contains lactose and sodium”.

Appearance of the product and contents of the package

25 mg: yellow-coated, round, biconvex tablets, engraved with a 25 on one face. Dimensions: diameter 6 mm.

50 mg: yellow-coated, round, biconvex tablets, engraved with a 50 on one face. Dimensions: diameter 7.5 mm.

Eplerenona Krka is available in packs containing:

• 10, 20, 28, 30, 50, 90, and 100 film-coated tablets in blisters.
• 10 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 90 x 1, and 100 x 1 film-coated tablets in perforated unit-dose blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturing:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura a 10, 28108 Alcobendas, Madrid, Spain.

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:

Last revision date of this leaflet: October 2024

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es