Nonpres

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Nonpres, 25 mg, coated tablets

Nonpres, 50 mg, coated tablets

Eplerenone

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

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your 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. recent 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 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 the blood (hyperkalemia)
• if you are taking medicines that remove excess fluid from the body (potassium-sparing diuretics)
• if you have severe kidney disease
• if you have severe liver disease
• if you are taking antifungal medicines (ketoconazole or itraconazole)
• if you are taking medicines against HIV (nelfinavir or ritonavir)
• if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin)
• if you are taking nefazodone, used to treat depression
• if you are 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 taking Nonpres, discuss it with your doctor, pharmacist, or nurse

• if you have kidney or liver disease (see also "When not to take Nonpres")
• if you are taking lithium salts (usually used to treat manic-depressive disorders, also called bipolar disorders)
• if you are 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 with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or recently, and about the medicines you plan to take.

• itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines against HIV), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression) - these medicines slow down the metabolism of Nonpres, thereby 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 disease, and some 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 drugs (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-adrenergic blockers, such as prazosin or alfuzosin (used to treat high blood pressure and some 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 some 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 (anticoagulant) - 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 (antiviral medicine used to treat HIV infections), 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, thereby prolonging its effect on 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 accelerate the metabolism of Nonpres, thereby weakening its effect.

Nonpres with food and drink

Nonpres can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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. You should ask your doctor whether to stop breastfeeding or stop taking Nonpres.

Driving and using machines

After taking Nonpres, dizziness may occur. In this case, do not drive or operate machinery.

Nonpres contains lactose monohydrate

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

Nonpres contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Nonpres

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Nonpres tablets can be taken with or without food. Swallow the tablets whole with a glass of water. Nonpres is usually taken with other medicines used in heart failure, e.g. beta-blockers. The usual starting dose is one 25 mg tablet once a day. After about 4 weeks, your doctor will advise you to increase 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. Your doctor will advise you to have your potassium levels checked before starting Nonpres, within the first week, and after one month of treatment, as well as after any dose change. Depending on your potassium levels, your doctor may adjust your dose. If you have mild kidney disease, treatment should be started with one 25 mg tablet per day. If you have moderate kidney disease, treatment should be started with one 25 mg tablet every other day. Your doctor may advise you to adjust your dose, taking into account your potassium levels. Nonpres should not be used in patients with severe kidney disease. In patients with mild or moderate liver disease, it is not necessary to adjust the starting dose. In case of liver or kidney disease, it may be necessary to check potassium levels more frequently (see also "When not to take Nonpres"). Elderly patients: no dose adjustment is required. Children and adolescents: Nonpres is not recommended.

What to do if you take more Nonpres than you should

If you have taken more Nonpres than you should, contact your doctor or pharmacist immediately. The most likely symptoms 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).

What to do if you miss a dose of Nonpres

If it is almost time for your next dose, skip the missed dose and take the next one as usual. Otherwise, take the missed dose as soon as you remember, provided that it is more than 12 hours before your next dose. Then, return to your usual dosing schedule. Do not take a double dose to make up for a forgotten dose.

What to do if you stop taking Nonpres

It is important to take Nonpres as prescribed by your doctor, unless your doctor advises you to stop treatment. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nonpres can cause side effects, although not everybody gets them. If you experience any of the following symptoms, seek medical attention 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 malaise
• kidney inflammation
• breast enlargement in men
• changes in some blood test results

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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, you can help provide more information on the safety of this medicine.

5. How to store Nonpres

Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the carton and blister after (EXP). The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nonpres contains

The active substance is eplerenone. Each Nonpres 25 mg coated tablet contains 25 mg of eplerenone. The active substance is eplerenone. Each Nonpres 50 mg coated 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 coated tablets are: beige, round, biconvex, with "25" engraved on one side. Nonpres 25 mg coated tablets are available in packs of 30 coated tablets. Nonpres 50 mg coated tablets are: beige, round, biconvex, with "50" engraved on one side. Nonpres 50 mg coated tablets are available in packs of 30 coated 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