Eplerenone Krka 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Eplerenona Krka 25 mg film-coated tablets EFG

Eplerenona Krka 50 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Eplerenona Krka is and what it is used for
2. What you need to know before taking Eplerenona Krka
3. How to take Eplerenona Krka
4. Possible side effects
5. How to store Eplerenona Krka
6. Contents of the pack and other information

1. What Eplerenona Krka is and what it is used for

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

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

you have recently had a myocardial infarction, in combination with other medicines used to treat your heart failure, or you have persistent mild symptoms despite the treatment you have been receiving up to now.

2. What you need to know before taking Eplerenone Krka

Do not take Eplerenone Krka

• if you are allergic to eplerenone or to any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of potassium in your blood (hyperkalaemia)
• if you are taking medicines from groups that help your body eliminate excess fluid (potassium-sparing diuretics)
• if you have severe renal impairment
• if you have severe hepatic impairment
• if you are taking medicines used to treat fungal infections (ketoconazole or itraconazole)
• if you are taking antiviral medicines used to treat HIV infections (nelfinavir or ritonavir)
• if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin)
• if you are taking nefazodone for depression
• if you are simultaneously taking medicines used to treat certain heart conditions or hypertension (such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs)).

Warnings and precautions

Talk to your doctor or pharmacist before taking eplerenone:

• if you have kidney or liver disease (see also “Do not take Eplerenone Krka”)
• if you are taking lithium (commonly used for manic-depressive disorder, also called bipolar disorder)
• if you are taking tacrolimus or ciclosporin (used to treat skin conditions such as psoriasis or eczema and to prevent rejection of transplanted organs)

Children and adolescents

The safety and efficacy of eplerenone in children and adolescents has not been established.

Other medicines and Eplerenone Krka

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

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for treating HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the metabolism of eplerenone, thereby prolonging its effect in the body.

• Potassium-sparing diuretics (medicines that help eliminate excess fluid from the body) or potassium supplements (salt tablets), as these medicines increase the risk of high potassium levels in the blood.

• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) taken together (used to treat high blood pressure, heart disease, or certain kidney conditions), as these medicines may increase the risk of high potassium levels in the blood.

• Lithium (commonly used for manic-depressive disorder, also called bipolar disorder). The use of lithium together 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 lead to the following adverse reactions: loss of appetite, vision disturbances, fatigue, muscle weakness, and muscle cramps.

• Ciclosporin or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent rejection of transplanted organs). These medicines may cause kidney problems and thus increase the risk of high potassium levels in the blood.

• Non-steroidal anti-inflammatory drugs (NSAIDs – certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines may cause kidney problems 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 blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions), may lead to a drop in blood pressure and cause dizziness upon standing.

• Tricyclic antidepressants such as amitriptyline or amoxapine (for the treatment of depression), antipsychotics (known as neuroleptics) such as chlorpromazine or haloperidol (for the treatment of psychiatric disorders), amifostine (used during cancer chemotherapy), and baclofen (used to treat muscle spasms). These medicines may lead to a drop in blood pressure and cause dizziness upon standing.

• Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions) and tetracosactide (used mainly to diagnose and treat adrenal cortex disorders) may reduce the blood pressure-lowering effect of Eplerenone Krka.

• Digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with Eplerenone Krka.

• Warfarin (an anticoagulant medicine): Caution is required when administering warfarin, as high levels of warfarin in the blood may cause changes in the effect of Eplerenone Krka in the body.

• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for the treatment of HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for the treatment of heart problems and high blood pressure) reduce the metabolism of eplerenone, thereby prolonging the effect of Eplerenone Krka in the body.

• St. John’s wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy) may increase the metabolism of Eplerenone Krka and thus reduce its effect.

Taking Eplerenone Krka with food and drink

Eplerenone Krka can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medicine. The effect of Eplerenone Krka during pregnancy has not been evaluated in humans.

It is unknown whether eplerenone is excreted in breast milk. Your doctor will decide with you whether to discontinue breastfeeding or discontinue the treatment.

Driving and using machines

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

Eplerenone Krka contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

3. How to take Eplerenona Krka

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Eplerenona Krka tablets can be taken with food or on an empty stomach. Swallow the tablets whole with plenty of water.

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

Blood potassium levels should be measured before starting treatment with Eplerenona Krka, during the first week, and one month after starting treatment or after any dose adjustment. Your doctor may adjust the dose based on your blood potassium levels.

If you have mild renal impairment, you should start treatment with one 25 mg tablet daily. If you have moderate renal impairment, treatment should be initiated with one 25 mg tablet every other day. These doses may be adjusted, as directed by your doctor, according to your blood potassium levels.

Eplerenona Krka is not recommended in patients with severe renal disease.

No initial dose adjustment is necessary in patients with mild to moderate hepatic impairment. If you have liver or kidney problems, you may require more frequent blood potassium monitoring (see also "Do not take Eplerenona Krka").

In elderly patients: no initial dose adjustment is required.

Use in children and adolescents

Eplerenona Krka is not recommended in children and adolescents.

If you take more Eplerenona Krka than you should

If you take more Eplerenona Krka than you should, contact your doctor or pharmacist immediately. If you have taken too much medicine, the most likely symptoms are low blood pressure (manifested as dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalaemia, high levels of potassium in the blood (manifested by muscle cramps, diarrhoea, nausea, dizziness or headache).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eplerenona Krka

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

Otherwise, take the tablet as soon as you remember, provided that more than 12 hours remain before the next scheduled dose. Then continue taking your medicine as usual.

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

If you stop taking Eplerenona Krka

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets 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 angioedema, an uncommon adverse effect (which may affect up to 1 in 100 people).

Other reported adverse effects include:

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

• elevated blood potassium levels (symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache)
• dizziness
• fainting
• elevated blood cholesterol levels
• insomnia (difficulty sleeping)
• headache
• heart discomfort, for example, irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhoea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasms
• increased blood urea levels
• increased blood creatinine levels, which may indicate kidney problems.

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

• infection
• eosinophilia (increase in certain white blood cells)
• dehydration
• elevated levels of triglycerides (fats) in blood
• low sodium levels in blood
• rapid heartbeat
• inflammation of the gallbladder
• drop in blood pressure that may cause dizziness when standing up
• thrombosis (blood clot) in the legs
• sore throat
• flatulence
• underactive thyroid
• increased blood glucose levels
• reduced sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in certain blood tests.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Krka

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

Do not use this medicine after the expiry date stated on the packaging and blister after the abbreviation EXP. The expiry date refers to the last day of the indicated month.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone Krka

• The active substance 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 sulphate in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 and yellow iron oxide (E172) in the film coating. See section 2 “Eplerenone Krka contains lactose and sodium”.

Appearance of the product and contents of the pack

25 mg: yellow, film-coated, round, biconvex tablets marked with "25" on one side. Dimensions: 6 mm in diameter.

50 mg: yellow, film-coated, round, biconvex tablets marked with "50" on one side. Dimensions: 7.5 mm in diameter.

Eplerenone 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 single-dose perforated blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer:

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

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

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

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

This medicine is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Date of the latest review of this leaflet: October 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/