ENPLERASA 50 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Enplerasa, 25 mg, film-coated tablets
3. Enplerasa, 50 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Enplerasa and what is it used for
5. Important information before taking Enplerasa
   1. When not to take Enplerasa
   2. Warnings and precautions
   3. Children and adolescents
   4. Enplerasa and other medicines
   5. Enplerasa with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Enplerasa contains lactose and sodium
6. How to take Enplerasa
   1. Taking a higher dose of Enplerasa than recommended
   2. Missing a dose of Enplerasa
   3. Stopping Enplerasa treatment
7. Possible side effects
   1. Reporting side effects
8. How to store Enplerasa
9. Contents of the packaging and other information
   1. What Enplerasa contains
   2. What Enplerasa looks like and what the pack contains
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   6. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Enplerasa, 25 mg, film-coated tablets

Enplerasa, 50 mg, film-coated tablets

Eplerenone

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Enplerasa and what is it used for
• 2. Important information before taking Enplerasa
• 3. How to take Enplerasa
• 4. Possible side effects
• 5. How to store Enplerasa
• 6. Contents of the packaging and other information

1. What is Enplerasa and what is it used for

Enplerasa belongs to a group of medicines called selective aldosterone antagonists. These medicines block the action of aldosterone, a substance produced by the body that controls blood pressure and heart function. High levels of aldosterone can cause changes in the body that lead to heart failure.

Enplerasa is used to treat heart failure to prevent the worsening of the disease and reduce the number of hospitalizations in patients who:

• 1. have recently had a heart attack - in combination with other medicines used to treat heart failure or
• 2. have persistent, mild symptoms despite previous treatment.

2. Important information before taking Enplerasa

When not to take Enplerasa

• if the patient is allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has high levels of potassium in the blood (hyperkalemia);
• if the patient is taking medicines that remove excess fluid from the body (potassium-sparing diuretics);
• if the patient has severe kidney disease;
• if the patient has severe liver disease;
• if the patient is taking antifungal medicines (ketoconazole or itraconazole);
• if the patient is taking antiviral medicines to treat HIV infection (nelfinavir or ritonavir);
• if the patient is taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin);
• if the patient is taking nefazodone, used to treat depression;
• if the patient is taking medicines used to treat certain heart diseases or high blood pressure (so-called ACE inhibitors and angiotensin receptor antagonists).

Warnings and precautions

Before taking Enplerasa, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney or liver disease (see also "When not to take Enplerasa");
• if the patient is taking lithium (usually used to treat bipolar disorder);
• if the patient is taking tacrolimus or cyclosporin (medicines used to treat skin diseases, such as psoriasis or eczema, and to prevent the rejection of a transplanted organ).

Children and adolescents

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

Enplerasa and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Itraconazole or ketoconazole (medicines used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines used to treat HIV infection), clarithromycin, telithromycin (medicines used to treat bacterial infections) or nefazodone (a medicine used to treat depression), as these medicines can weaken the breakdown of Enplerasa, thus prolonging its effect on the body;
• Potassium-sparing diuretics (medicines that help remove excess fluid from the body) and potassium supplements (replacing salt), as these medicines can increase the risk of high levels of potassium in the blood;
• ACE inhibitors and angiotensin receptor antagonists (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medicines can increase potassium levels in the blood.
• Lithium (used to treat bipolar disorder). It has been shown that taking lithium with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) can increase lithium levels in the blood, leading to side effects such as loss of appetite, vision disturbances, fatigue, muscle weakness, and tremors;
• Cyclosporin or tacrolimus (medicines used to treat skin diseases, such as psoriasis or eczema, and to prevent the rejection of a transplanted organ). These medicines can cause kidney function disorders and 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 function disorders and increase the risk of high 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;
• Alpha-1-adrenergic blockers (such as prazosin or alfuzosin, used to treat high blood pressure and certain prostate diseases) can cause a decrease in blood pressure and dizziness when standing up;
• Tricyclic antidepressants, such as amitriptyline or amoxapine (used to treat depression), antipsychotic medicines (also known as neuroleptics), such as chlorpromazine or haloperidol (used to treat mental disorders),

amifostine (a medicine used in cancer chemotherapy) and baclofen (a medicine used to treat increased muscle tension). These medicines can cause a decrease in blood pressure and dizziness when standing up;

• Corticosteroids, such as hydrocortisone or prednisone (used to treat inflammatory conditions and certain skin diseases) and tetracosactide (a medicine used mainly in the diagnosis and treatment of adrenal cortex disorders), can lower blood pressure, weakening the effect of Enplerasa;
• Digoxin (a medicine used to treat heart disease). Taking Enplerasa with digoxin may increase digoxin levels in the blood;
• Warfarin (an anticoagulant): caution should be exercised when taking warfarin, as its high levels in the blood can change the effect of Enplerasa on the body;
• Erythromycin (a medicine used to treat bacterial infections), saquinavir (an antiviral medicine used to treat HIV infection), fluconazole (a medicine used to treat fungal infections), amiodarone, diltiazem, and verapamil (medicines used to treat heart disease and high blood pressure) can weaken the breakdown of Enplerasa, thus prolonging its effect on the body;
• St. John's Wort (a herbal medicine), rifampicin (a medicine used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (medicines used, among other things, to treat epilepsy) can enhance the breakdown of Enplerasa, thus weakening its effect.

Enplerasa with food and drink

Enplerasa can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

The effect of Enplerasa in pregnant women has not been evaluated.

It is not known whether eplerenone passes into human milk. The patient should consult their doctor whether to stop breastfeeding or stop taking Enplerasa.

Driving and using machines

While taking Enplerasa, dizziness may occur. The patient should not drive or operate machinery in such cases.

Enplerasa contains lactose and sodium

If the patient has been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is considered "sodium-free".

3. How to take Enplerasa

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should ask their doctor or pharmacist.

Enplerasa can be taken with or without food. The tablets should be swallowed whole, with a large amount of water.

Enplerasa is usually taken with other medicines used to treat heart failure, such as beta-blockers. The usual starting dose is one 25 mg tablet once a day, increased after about 4 weeks to 50 mg once a day (in the form of one 50 mg tablet or two 25 mg tablets). The maximum dose is 50 mg per day.

The doctor will recommend checking potassium levels in the blood before starting Enplerasa, in the first week of treatment, and one month after starting treatment or after changing the dose.

Depending on the potassium level in the blood, the doctor may adjust the dose.

Patients with mild kidney disease should start treatment with one 25 mg tablet once a day.

If the kidney disease is moderate, the starting dose is one 25 mg tablet taken every other day. The doctor may change these doses depending on the patient's potassium level in the blood.

It is not recommended to take Enplerasa in patients with severe kidney disease.

In patients with mild or moderate liver disease, it is not necessary to modify the starting dose. In patients with liver or kidney function disorders, it may be necessary to monitor potassium levels in the blood more frequently (see also "When not to take Enplerasa").

Elderly patients: it is not necessary to modify the starting dose.

Children and adolescents: it is not recommended to take Enplerasa.

Taking a higher dose of Enplerasa than recommended

If the patient takes a higher dose of Enplerasa than recommended, they should immediately consult their doctor or pharmacist. The most likely symptoms of overdose are: low blood pressure (felt as dizziness, 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.

Missing a dose of Enplerasa

If it is almost time for the next dose, the patient should skip the missed dose and take the next one at the right time.

In other cases, the patient should take the dose as soon as they remember, provided that there are more than 12 hours left until the next dose. Then, they should return to their usual dosing schedule.

The patient should not take a double dose to make up for the missed dose.

Stopping Enplerasa treatment

It is important to take Enplerasa as prescribed, unless the doctor recommends stopping treatment.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following symptoms, they should immediately seek medical attention:

• swelling of the face, tongue, or throat;
• difficulty swallowing;
• hives and difficulty breathing. These are symptoms of angioedema, a not very common (occurring in no more than 1 in 100 people) side effect.

Other reported side effects include:

Common side effects(occurring in no more than 1 in 10 patients):

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

Uncommon side effects(occurring in no more than 1 in 100 patients):

• infection,
• eosinophilia (an increase in the number of white blood cells),
• low levels of sodium in the blood,
• dehydration,
• high levels of triglycerides (fats) in the blood,
• rapid heartbeat,
• gallbladder inflammation,
• decrease in blood pressure that can cause dizziness when changing body position to standing,
• blood clots (blood clots) in the legs,
• throat pain,
• bloating,
• hypothyroidism,
• high levels of glucose in the blood,
• decreased sensitivity to touch,
• increased sweating,
• musculoskeletal pain,
• general malaise,
• kidney inflammation,
• breast enlargement in men,
• changes in blood test results.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 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.

Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Enplerasa

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after EXP.

The expiry date refers to the last day of the month stated.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Enplerasa contains

• The active substance is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate, sodium lauryl sulfate. Coating: hypromellose, titanium dioxide (E 171), macrogol 400, polysorbate 80, yellow iron oxide (E 172). See section 2 "Enplerasa contains lactose and sodium".

What Enplerasa looks like and what the pack contains

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

Enplerasa, 50 mg: Yellow, round, biconvex film-coated tablets with "50" engraved on one side. Dimensions: diameter 7.5 mm.

Enplerasa is available in cartons 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.

Not all 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

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

For more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

Tel. 22 57 37 500

Date of last revision of the leaflet: