Nonpres

PATIENT INFORMATION LEAFLET

Leaflet included in the packaging: information for the user

Nonpres, 25 mg, coated tablets

Nonpres, 50 mg, coated tablets

Eplerenone

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Nonpres and what is it used for

Nonpres 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. Increased levels of aldosterone can cause changes in the body that lead to heart failure. Nonpres is used to treat heart failure to prevent its worsening and reduce the number of hospitalizations in case of:

• 1. recently suffered myocardial infarction - in combination with other medicines used in heart failure, or
• 2. persistent, mild symptoms despite previous treatment.

2. Important information before taking Nonpres

When not to take Nonpres:

• 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 anti-HIV medicines (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 in combination with angiotensin receptor antagonists - AIIRA).

Warnings and precautions

Before starting to take Nonpres, the patient should discuss it with their doctor, pharmacist, or nurse.

• if the patient has kidney or liver disease (see also "When not to take Nonpres")
• if the patient is taking lithium salts (usually used to treat manic-depressive disorders, also called bipolar disorders)
• if the patient is taking tacrolimus or cyclosporin (used to treat skin diseases, such as psoriasis or eczema, and to prevent rejection of a transplanted organ)

Children and adolescents

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

Nonpres and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

• itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (anti-HIV medicines), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression) - these medicines slow down the metabolism of Nonpres, thus prolonging its effect on the body.
• potassium-sparing diuretics (medicines that help remove excess fluid from the body) and potassium supplements - these medicines increase the risk of high levels of potassium in the blood.
• ACE inhibitors in combination with angiotensin receptor antagonists (AIIRA) used to treat high blood pressure, heart diseases, and certain kidney diseases - these medicines may increase the risk of high levels of potassium in the blood.
• lithium (usually used to treat manic-depressive disorders, also called bipolar disorders)
• concomitant use of lithium with diuretics and ACE inhibitors increased lithium levels in the blood, which could cause side effects such as loss of appetite, vision disturbances, fatigue, muscle weakness, and tremors.
• cyclosporin or tacrolimus (used to treat skin diseases, such as psoriasis or eczema, and to prevent rejection of a transplanted organ) - these medicines may cause kidney function disorders and thus increase the risk of high levels of potassium in the blood.
• non-steroidal anti-inflammatory medicines (NSAIDs - some painkillers, such as ibuprofen, used to relieve pain, stiffness, and inflammation) - these medicines may cause kidney function disorders 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-adrenolytics, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate diseases) - may cause decreased blood pressure and dizziness when changing body position to standing.

standing.

• tricyclic antidepressants, such as amitriptyline or amoxapine (used to treat depression), antipsychotic medicines also called neuroleptics, such as chlorpromazine or haloperidol (used to treat mental disorders), amifostine (used in cancer chemotherapy) and baclofen (used in case of increased muscle tension) - these medicines may cause decreased blood pressure and dizziness when changing body position to standing.
• glucocorticosteroids, such as hydrocortisone or prednisone (used to treat inflammatory conditions and certain skin diseases) and tetracosactide (mainly used to diagnose and treat adrenal cortex disorders) - may weaken the blood pressure-lowering effect of Nonpres.
• digoxin (used to treat heart diseases) - concomitant use with Nonpres may increase digoxin levels in the blood.
• warfarin (an anticoagulant medicine) - caution should be exercised when using warfarin, as increased warfarin levels in the blood may disrupt the effect of Nonpres on the body.
• erythromycin (used to treat bacterial infections), saquinavir (an anti-HIV medicine), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart diseases and high blood pressure) - slow down the metabolism of Nonpres, thus prolonging its effect on the body.
• St. John's Wort (a herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among other things, to treat epilepsy) - may accelerate the metabolism of Nonpres, thus weakening its effect.

Nonpres with food and drink

Nonpres can be taken during meals or independently of meals.

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 Nonpres during pregnancy has not been evaluated in humans. It is not known whether eplerenone passes into breast milk. The patient should consult their doctor whether to stop breastfeeding or stop taking Nonpres.

Driving and using machines

After taking Nonpres, dizziness may occur. In this case, the patient should not drive vehicles or operate machines.

Nonpres contains lactose monohydrate

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

Nonpres contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Nonpres

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. Nonpres tablets can be taken during meals or on an empty stomach. The tablets should be swallowed whole, with a large amount of water. Nonpres is usually taken with other medicines used in heart failure, e.g., beta-adrenolytics. The usual initial dose is one 25 mg tablet once a day. After about 4 weeks, the doctor will recommend increasing the dose to 50 mg once a day (one 50 mg tablet or two 25 mg tablets). The maximum dose is 50 mg per day. The doctor will prescribe a blood test to check potassium levels before starting Nonpres, within the first week, and after one month of treatment, as well as after changing the dose. Depending on the potassium level in the blood, the doctor may adjust the dose of Nonpres. If the patient has mild kidney disease, treatment should be started with one 25 mg tablet per day. If the patient has moderate kidney disease, treatment should be started with one 25 mg tablet every other day. The doctor may recommend adjusting the dose, taking into account the potassium level in the blood. In patients with severe kidney disease, Nonpres should not be taken. In patients with mild or moderate liver diseases, it is not necessary to adjust the initial dose. In case of liver or kidney diseases, it may be necessary to perform more frequent blood tests to check potassium levels (see also "When not to take Nonpres"). Elderly patients: no dose adjustment is required. Children and adolescents: Nonpres should not be taken.

Taking a higher dose of Nonpres than recommended

In case of taking a higher dose of Nonpres than recommended, the patient should immediately contact their doctor or pharmacist. The most likely symptoms that may occur in case of overdose are low blood pressure (causing dizziness, dizziness, blurred vision, weakness, sudden loss of consciousness) and hyperkalemia (high levels of potassium in the blood), causing muscle cramps, diarrhea, nausea, dizziness, or headache).

Missing a dose of Nonpres

If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the usual time. In other cases, the patient should take the dose as soon as they remember, provided that it is more than 12 hours before the next dose. Then, the patient should return to their usual dosing schedule. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Nonpres

It is important to take Nonpres according to the recommendations, 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, Nonpres can cause side effects, although not everybody gets them. If any of the following symptoms occur, the patient should seek medical help immediately:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing These are symptoms of angioedema, a not very common side effect (may occur in less than 1 in 100 people).

Other reported side effects include: Common side effects(may occur in less than 1 in 10 people):

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

Uncommon side effects(may occur in less than 1 in 100 people)

• infection
• eosinophilia (increased levels of a type of white blood cell)
• low levels of sodium in the blood
• dehydration
• high levels of triglycerides (fats) in the blood
• rapid heart rate
• gallbladder inflammation
• decreased blood pressure, which may cause dizziness when changing body position to standing
• thrombosis (blood clots) in the legs
• sore throat
• bloating
• hypothyroidism
• high blood sugar levels
• decreased tactile sensation
• increased sweating
• musculoskeletal pain
• general feeling of being unwell
• kidney inflammation
• breast enlargement in men
• changes in some blood test results

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal 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 or its representative. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Nonpres

The medicine should be stored out of sight and reach of children. This medicine does not require special storage conditions. Do not use this medicine after the expiry date stated on the carton and blister after: (EXP). The expiry date refers to the last day of the month. 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 pack and other information

What Nonpres contains

The active substance of Nonpres is eplerenone. Each Nonpres 25 mg tablet contains 25 mg of eplerenone. The active substance of Nonpres is eplerenone. Each Nonpres 50 mg tablet contains 50 mg of eplerenone. The other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, talc, and magnesium stearate, coating: hypromellose, macrogol 400, polysorbate 80 (E433), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Nonpres looks like and contents of the pack

Nonpres 25 mg tablets are: beige, round, biconvex, with the inscription "25" on one side. Nonpres 25 mg tablets are available in packs of 30 tablets. Nonpres 50 mg tablets are: beige, round, biconvex, with the inscription "50" on one side. Nonpres 50 mg tablets are available in packs of 30 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

Manufacturer

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland Nonpres Date of last revision of the leaflet:01.2022