EPLERENONE KRKA 50 mg FILM-COATED TABLETS

2. What you need to know before you take Eplerenona Krka

Do not takeEplerenona Krka

• if you are allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of potassium in your blood (hyperkalemia)
• if you are taking medicines from groups that help eliminate excess fluid in the body (potassium-sparing diuretics)
• if you have severe kidney impairment
• if you have severe liver 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 to treat depression
• if you are taking medicines used to treat certain heart diseases or high blood pressure (such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs)) at the same time.

Warnings and precautions

Consult your doctor or pharmacist before starting to take eplerenone:

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

Children and adolescents

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

Other medicines and Eplerenona Krka

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

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for HIV treatment), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression), as these medicines reduce the metabolism of eplerenone, and thus prolong its effect in the body.
• Potassium-sparing diuretics (medicines that help eliminate excess fluid in the body) or potassium supplements (salt tablets) as these medicines increase the risk of high levels of potassium in the blood.
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) at the same time (used to treat high blood pressure, heart disease, or certain kidney diseases) as these medicines may increase the risk of high levels of potassium in the blood.

• Lithium (used to treat manic-depressive disorder, also known as bipolar disorder). The use of lithium with diuretics and ACE inhibitors has been shown to cause high levels of lithium in the blood, which can cause the following adverse reactions: loss of appetite, vision changes, fatigue, muscle weakness, and muscle cramps.
• Cyclosporin or tacrolimus (used to treat skin diseases such as psoriasis or eczema and to prevent organ rejection after transplantation). These medicines can cause kidney problems and thus increase the risk of high levels of potassium in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs - certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines can cause kidney problems and thus 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 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 standing up.
• Tricyclic antidepressants such as amitriptyline or amoxapine (for the treatment of depression), antipsychotics (also 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 cause a decrease in blood pressure and dizziness when standing up.
• Corticosteroids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin diseases) and tetracosactide (used primarily to diagnose and treat adrenal cortex diseases) may reduce the blood pressure-lowering effect of Eplerenona Krka.
• Digoxin (used in the treatment of heart diseases). Blood levels of digoxin may increase when taken with Eplerenona Krka.
• Warfarin (an anticoagulant medicine): Caution is required when administering warfarin doses because high levels of warfarin in the blood may affect the effect of Eplerenona Krka in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (antiviral medicine for HIV treatment), 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, thus prolonging the effect of Eplerenona 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 Eplerenona Krka and thus reduce its effect.

Taking Eplerenona Krka with food and drinks

Eplerenona Krka can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine. The effect of Eplerenona Krka during pregnancy in humans has not been evaluated.

It is not known whether eplerenone is excreted in breast milk. Your doctor will decide with you whether to interrupt breast-feeding or stop treatment.

Driving and using machines

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 some sugars, consult with him before taking this medicine.

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

3. How to take Eplerenona Krka

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, 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 given together with other medicines for heart failure, for example, beta-blockers. The recommended initial dose is one 25 mg tablet once a day, increasing after about 4 weeks to 50 mg daily (one 50 mg tablet or two 25 mg tablets). The maximum dose regimen is 50 mg per day.

Potassium levels in the blood should be measured before starting treatment with Eplerenona Krka, during the first week, and after one month of starting treatment or after a change in dose. Your doctor may adjust the dose based on your potassium levels in the blood.

If you have mild kidney impairment, you should start treatment with a 25 mg tablet per day, and if you have moderate kidney impairment, you should start treatment with a 25 mg tablet every other day. These doses may be adjusted, if your doctor indicates, and according to your blood potassium levels.

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

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

In elderly patients: no initial dose adjustment is necessary.

Use in children and adolescents

In children and adolescents, Eplerenona Krka is not recommended.

If you take more Eplerenona Krka than you should

If you take more Eplerenona Krka than you should, consult your doctor or pharmacist immediately. If you have taken too much medicine, the most likely symptoms will be low blood pressure (manifested as dizziness, blurred vision, weakness, sudden 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 Toxicology Information Service, phone: 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 dose you missed and take the next dose when it is due.

Otherwise, take the dose as soon as you remember, provided that it is more than 12 hours until the time of your next dose. Go back to taking your medicine as usual.

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

If you stop taking Eplerenona Krka

It is important to keep taking Eplerenona Krka as your doctor has told you, unless your doctor tells you to stop.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following:

Seek medical attention immediately

• swelling of the face, tongue, or throat
• difficulty swallowing
• blisters and difficulty breathing

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

Other reported side effects include:

Common(may affect up to1 in 10 people):

• high levels of potassium in the blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• dizziness
• fainting
• high levels of cholesterol in the blood
• insomnia (difficulty sleeping)
• headache
• heart problems, such as irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasms
• increased levels of urea in the blood
• increased levels of creatinine in the blood, which may indicate kidney problems.

Uncommon(may affect up to1 in 100 people):

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use, https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenona Krka

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

Do not use this medicine after the expiry date which is stated on the carton and blister after the abbreviation EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the carton and any remaining medicine in the SIGRE collection point at your pharmacy. If you have any further questions on how to dispose of the carton and any remaining medicine, ask your pharmacist. This will help protect the environment.

6. Package Contents and Additional Information

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 tablet core, and hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80, and yellow iron oxide (E172) in the film coating. See section 2 "Eplerenona Krka contains lactose and sodium".

Appearance of the Product and Package Contents

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

50 mg: yellow, round, biconvex, film-coated tablets, engraved with a 50 on one side. 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

Manufacturer

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

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

You can request more information about this medicinal product from the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 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:

Date of the last revision of this leaflet:October2024

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/