25 mg and 50 mg film-coated tablets 
eplerenone

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Eplerenone Krka is and what it is used for 
2. What you need to know before you use Eplerenone Krka 
3. How to use Eplerenone Krka 
4. Possible side effects 
5. How to store Eplerenone Krka 6. Contents of the pack 
and other information 

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

Eplerenone Krka belongs to a group of medicines called selective aldosterone antagonists. These antagonists inhibit the effect of aldosterone, a substance that the body produces to regulate blood pressure and heart function. High levels of aldosterone can cause changes in the body that lead to heart failure.

Eplerenone Krka is used to treat your heart failure to prevent deterioration and reduce the number of hospital stays if you have:

  1. have had a recent heart attack, in combination with other medicines used to treat your heart failure, or
  2. had persistent, mild symptoms despite the treatment you have received so far.

Eplerenone contained in Eplerenone Krka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Eplerenone Krka

Do not use Eplerenone Krka

  • if you are allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6)
  • if you have elevated levels of potassium in your blood ( hyperkalemia )
  • if you take diuretics that reduce the body’s excess fluid (potassium-sparing diuretics )
  • if you have severe kidney disease
  • if you have severe liver disease
  • if you are taking medicines for fungal infections ( ketoconazole or itraconazole)
  • if you take medicines to prevent viruses to treat HIV (nelfinavir or ritonavir)
  • if you are taking antibiotics to treat bacterial infections (clarithromycin or telithromycin)
  • if you are taking nefazodone to treat depression
  • if you are taking medicines to treat certain heart conditions or high blood pressure (so-called angiotensin-converting enzyme (ACE) inhibitors and an angiotensin receptor blocker (ARB)) together.

Warnings and cautions

Talk to your doctor or pharmacist before taking Eplerenone Krka.

  • if you have impaired kidney or liver function (see also “Do not take Eplerenone Krka”)
  • if you are taking lithium (commonly used for depressive illness, also known as bipolar disorder )
  • if you are taking tacrolimus or cyclosporine (used to treat skin conditions such as psoriasis or eczema and to prevent rejection after organ transplantation)

Children and young people

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

Other medicines and Eplerenone Krka

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

  • Itraconazole or ketoconazole (for the treatment of fungal infections), ritonavir, nelfinavir (medicines to prevent infections by HIV – infection ), clarithromycin, telithromycin (drugs for bacterial infections), or nefazadone (depression), since these drugs can reduce the degradation of Eplerenone Krka and thereby prolonging its effect in the body.
  • Potassium-sparing diuretics (medicines that help reduce the body’s excess fluid) and potassium supplements (salt tablets), as these medicines increase the risk of increased levels of potassium in your blood.
  • Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) together (which are used to treat high blood pressure, heart disease, or certain kidney conditions), as these medicines may increase the risk of high levels of potassium in your blood.
  • Lithium (commonly used to treat manic-depressive illness, also known as bipolar disorder ). The use of lithium together with diuretics and ACE inhibitors (for the treatment of high blood pressure and heart disease) has been shown to cause elevated levels of lithium in the blood, which can cause side effects: loss of appetite, visual disturbances, fatigue, muscle weakness, muscle twitching.
  • Cyclosporine or tacrolimus (to treat skin conditions such as psoriasis or eczema, and to prevent organ rejection after organ transplantation). These drugs can cause problems with the kidneys and thus increase the risk of elevated levels of potassium in the blood.
  • Non-steroidal anti-inflammatory drugs ( NSAIDs – some painkillers, such as ibuprofen, are used to treat pain, stiffness, and inflammation ). These drugs can lead to kidney problems and thus increase the risk of elevated levels of potassium in the blood.
  • Trimethoprim (a medicine used to treat bacterial infections) may increase the risk of high levels of potassium in the blood.
  • Alpha1-receptor blockers, such as prazosin or alfuzosin (used for high blood pressure and certain prostate conditions) can cause a drop in blood pressure and dizziness when standing up.
  • Tricyclic antidepressants such as amitriptyline or amoxapine (for the treatment of depression), antipsychotics (also called neuroleptics ) such as chlorpromazine or haloperidol (for the treatment of mental illness), amifostine (used during cancer treatment), and baclofen (for the treatment of muscle spasms). These medicines can cause a drop in blood pressure and dizziness when standing up.
  • Glucocorticoids such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions) and tetracosactide (used mainly to diagnose and treat disorders of the adrenal cortex ) may reduce the antihypertensive effect of Eplerenone Krka.
  • Digoxin (used to treat heart disease). Levels of digoxin in the blood may increase when taken with Eplerenone Krka.
  • Warfarin (medicine for blood clots): Caution is warranted with warfarin treatment as high levels of warfarin in the blood may cause changes in the effect of Eplerenone Krka in the body.
  • Erythromycin (drugs for bacterial infections), saquinavir (medicines to prevent infections by HIV – infection ), fluconazole (antifungal medicines), amiodarone, diltiazem, and verapamil (to treat heart problems and high blood pressure ) decreases degradation of Eplerenone Krka, thus prolonging Eplerenone Krka effect in the body.
  • St. John’s wort ((traditional) herbal medicine), rifampicin (medicine for bacterial infections), carbamazepine, phenytoin, and phenobarbital (medicine for epilepsy, among others ) can increase the breakdown of Eplerenone Krka and thus reduce its effect.

Eplerenone Krka with food, drink, and alcohol

Eplerenone Krka can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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 this medicine.

The efficacy of Eplerenone Krka has not been studied during human pregnancy.

It is not known whether eplerenone is excreted in human breast milk. Discuss with your doctor whether you should stop breast-feeding or stop treatment with this medicine.

Driving and using machines

You may feel dizzy after taking Eplerenone Krka. In this case, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Eplerenone Krka contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free’. is next to “sodium-free”.

How to use Eplerenone Krka

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Eplerenone Krka can be taken with food or on an empty stomach. Swallow the tablets whole along with a copious amount of liquid.

Eplerenone Krka is normally given with other medicines for heart failure, such as beta-blockers. The usual starting dose is 25 mg once a day, which after about 4 weeks is increased to 50 mg once a day (either as a 50 mg tablet or two 25 mg tablets). The maximum dosage is 50 mg daily.

Potassium levels in the blood should be checked before treatment with Eplerenone Krka, during the first week of treatment, and one month after starting a treatment or changing the dose. Dose one may need to be adjusted by your doctor, depending on the potassium levels in your blood.

If you have mild renal impairment, you should start with a 25 mg tablet every day. And if you have moderate kidney function, you should start with a 25 mg tablet every other day. These doses can be adjusted according to your doctor’s recommendation and based on the potassium level in your blood. Eplerenone Krka is not recommended for patients with severe renal impairment.

The starting dose does not need to be adjusted in patients with mild to moderate hepatic impairment. If you have liver or kidney problems, your blood potassium levels may need to be checked more often (see also “Do not take Eplerenone Krka”).

Elderly: No adjustment of the starting dose is required.

Children and adolescents: Eplerenone Krka is not recommended.

If you use more Eplerenone Krka then you should  

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you have taken too much medicine, the most likely symptoms will be low blood pressure (expressed as a “slight” feeling in your head, dizziness, blurred vision, weakness, acute unconsciousness) or hyperkalemia, elevated levels of potassium in the blood (expressed as muscle cramps, diarrhea, nausea, dizziness or headache).

If you forget to use Eplerenone Krka

If it is soon time for your next tablet, skip the missed tablet and take the next tablet as usual.

Otherwise, take the tablet as soon as you remember, provided it is more than 12 hours until you take the next tablet. Then return to your regular medication.

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

If you stop using Eplerenone Krka

It is important to continue taking Eplerenone Krka as prescribed unless your doctor tells you to stop your treatment.

If you have any further questions on the use of this product, 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 immediate medical attention

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

These are symptoms of angioneurotic edema, a less common side effect (affects up to 1 in 100 people).

Other reported side effects include:

Common side effects are (may affect up to 1 in 10):

  • elevated potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
  • fainting
  • dizziness
  • elevated 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
  • impaired renal function
  • rash
  • itching
  • back pain
  • feeling weak
  • muscle twitching
  • increased level of urea in the blood
  • increased content of creatinine in the blood which may indicate problems with the kidneys

Less common side effects are (may affect up to 1 in 100):

  • infection
  • eosinophilia (increase in certain white blood cells )
  • low sodium levels in the blood
  • dehydration
  • increased levels of triglycerides (fats) in the blood
  • fast heartbeat
  • inflammation of the gallbladder
  • lowered blood pressure which can sometimes cause dizziness when standing up
  • thrombosis (blood clot) in the legs
  • sore throat
  • gas formation
  • underactive thyroid gland
  • increase in blood sugar
  • the decreased sensation on touch
  • increased sweating
  • pain in muscles and bones
  • feeling sick
  • kidney inflammation
  • breast augmentation in men
  • changes in certain blood test results

5. How to store Eplerenone 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 EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

What Eplerenone Krka contains:

  • The active substance is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.
  • The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate,e and sodium lauryl sulfate in the tablet core and hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80, and yellow iron oxide (E172) in film. See section 2 “Eplerenone Krka contains lactose and sodium”.

What the medicine looks like and the contents of the pack

Eplerenone Krka 25 mg: Yellow, round, biconvex, film-coated tablets, marked “25” on one side. Dimensions: diameter 6 mm.

Eplerenone Krka 50 mg: Yellow, round, biconvex, film-coated tablets, marked “50” on one side. Dimensions: diameter 7.5 mm.

Eplerenone Krka is available in packs containing:

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

Krka, dd, Novo mesto, Šmarješka cesta 6.8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann – Straβe 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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