Package leaflet: Information for the user

Nonpres, 25 mg, coated tablets
Nonpres, 50 mg, coated tablets
Eplerenone
Please read this leaflet carefully before taking this medicine because it contains important information for you.

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 personally. Do not give it 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, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Nonpres is and what it is used for
Important information before taking Nonpres
How to take Nonpres
Possible side effects
How to store Nonpres
Contents of the pack and other information

1. What Nonpres is and what it is 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 regulates blood pressure and heart function. Increased levels of aldosterone may cause changes in the body leading to heart failure.
Nonpres is used in the treatment of heart failure to prevent its worsening and to reduce the number of hospitalisations in the following cases:

following a recent heart attack – in combination with other medicines used for heart failure, or
persistent, mild symptoms despite previous treatment.

2. Important information before using Nonpres

When not to use 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 blood potassium levels (hyperkalemia)
if the patient is taking diuretics that retain potassium (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 for HIV (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 conditions or high blood pressure (so-called angiotensin-converting enzyme inhibitors (ACE inhibitors) in combination with angiotensin II receptor antagonists (AIIRAs)).

Warnings and precautions
Before starting Nonpres, discuss this with your doctor, pharmacist, or nurse:

if the patient has kidney or liver disease (see also the section "When not to use Nonpres")
if the patient is taking lithium salts (usually used to treat manic-depressive disorders, also known as bipolar disorders)
if the patient is taking tacrolimus or cyclosporine (used to treat skin conditions such as psoriasis or eczema, or to prevent rejection of transplanted organs)

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 medicines the patient is currently taking, has recently taken, or plans to take.

Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for 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 in the body.
Potassium-sparing diuretics (medicines that help remove excess fluid from the body) and potassium supplements – these increase the risk of high blood potassium levels.
Angiotensin-converting enzyme (ACE) inhibitors in combination with angiotensin II receptor antagonists (AIIRAs), used to treat high blood pressure, heart diseases, and certain kidney conditions – these medicines may increase the risk of high blood potassium levels.
Lithium (usually used to treat manic-depressive disorders, also known as bipolar disorders) – taking lithium together with diuretics and ACE inhibitors (used to treat high blood pressure and heart diseases) may increase lithium blood levels, potentially causing adverse effects such as loss of appetite, vision disturbances, fatigue, muscle weakness, and muscle tremors.
Cyclosporine or tacrolimus (used to treat skin conditions such as psoriasis or eczema, or to prevent organ transplant rejection) – these medicines may cause kidney dysfunction and thereby increase the risk of high blood potassium levels.
Nonsteroidal anti-inflammatory drugs (NSAIDs – some painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation) – these medicines may cause kidney dysfunction and thereby increase the risk of high blood potassium levels.
Trimethoprim (used to treat bacterial infections) may increase the risk of high blood potassium levels.
Alpha-1-adrenergic blockers such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions) – may cause low blood pressure and dizziness upon changing position to standing.
Tricyclic antidepressants such as amitriptyline or amoxapine (used to treat depression), antipsychotics also known as neuroleptics such as chlorpromazine or haloperidol (used to treat mental disorders), amifostine (used in cancer chemotherapy), and baclofen (used in cases of increased muscle tone) – these medicines may cause low blood pressure and dizziness upon changing position to standing.
Glucocorticoids such as hydrocortisone or prednisone (used to treat inflammatory conditions and certain skin diseases) and tetracosactide (mainly used in diagnosing and treating adrenal cortex disorders) – may weaken the blood pressure-lowering effect of Nonpres.
Digoxin (used to treat heart conditions) – concomitant use with Nonpres may increase digoxin blood levels.
Warfarin (an anticoagulant) – caution is advised when using warfarin, as increased warfarin blood levels may interfere with the effect of Nonpres.
Erythromycin (used to treat bacterial infections), saquinavir (an antiviral used in HIV treatment), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart conditions and high blood pressure) – these slow down the metabolism of Nonpres, thereby prolonging its effect in the body.
St. John's wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, in epilepsy treatment) – may accelerate the metabolism of Nonpres and thereby reduce its effectiveness.

Nonpres with food and drink
Nonpres may be taken during or independent of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The effect of Nonpres during pregnancy has not been evaluated in humans.
It is not known whether eplerenone passes into human breast milk. Consult your doctor whether to discontinue breastfeeding or to stop taking the medicine.

Driving and using machines
Dizziness may occur after taking Nonpres. In such a case, do not drive or operate machinery.

Nonpres contains lactose monohydrate
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

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

3. How to use Nonpres

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Nonpres tablets may be taken with or without food. Swallow the tablets whole with a large amount of water.
Nonpres is usually taken together with other medicines used for heart failure, e.g. beta-blockers. The usual starting dose is one 25 mg tablet once daily. After approximately 4 weeks, the doctor will recommend increasing the dose to 50 mg once daily (one 50 mg tablet or two 25 mg tablets). The maximum dose is 50 mg per day.
The doctor will order a blood potassium level test before starting treatment with Nonpres, within the first week and one month after starting treatment, as well as after any dose adjustment.
Depending on the blood potassium level, the doctor may adjust the dose of the medicine.
In patients with mild kidney disease, treatment should be initiated with one 25 mg tablet daily. In patients with moderate kidney disease, treatment should be initiated with one 25 mg tablet every other day. The doctor may recommend dose adjustment based on blood potassium levels.
Nonpres is not recommended in patients with severe kidney disease.
In patients with mild or moderate liver disease, no initial dose adjustment is necessary. In case of liver or kidney disease, more frequent monitoring of blood potassium levels may be required (see also "When not to use Nonpres").
Elderly patients: no initial dose adjustment is required.
Children and adolescents: use of Nonpres is not recommended.
Taking more Nonpres than prescribed
If more than the prescribed amount of Nonpres has been taken, contact a doctor or pharmacist immediately. The most likely symptoms of overdose include low blood pressure (causing dizziness, blurred vision, weakness, sudden loss of consciousness) and hyperkalemia (high potassium levels in blood), which may cause muscle cramps, diarrhea, nausea, dizziness or headache.
Missing a dose of Nonpres
If it is almost time for the next dose, skip the missed tablet and take the next dose at the usual time.
Otherwise, take the tablet as soon as remembered, provided that more than 12 hours remain before the next scheduled dose. Then return to the regular dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Nonpres treatment
It is important to take Nonpres exactly as prescribed, unless the doctor advises stopping treatment.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody will get them.
If you experience any of the following symptoms, seek medical help immediately:

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

These are symptoms of angioedema, an uncommon adverse reaction (may occur in up to 1 in 100 people).

Other reported adverse reactions include:
Common adverse reactions (may occur in up to 1 in 10 people):

increased blood potassium levels (symptoms include: muscle cramps, diarrhoea, nausea, dizziness or headache)
fainting
central dizziness
increased blood cholesterol levels
insomnia (difficulty falling asleep)
headache
heart disorders, e.g. heart rhythm disturbances and heart failure
cough
constipation
low blood pressure
diarrhoea
nausea
vomiting
kidney function disorders
rash
back pain
fatigue
muscle cramps
increased blood urea levels
increased blood creatinine levels, which may indicate impaired kidney function

Uncommon adverse reactions (may occur in up to 1 in 100 people):

infection
eosinophilia (increased number of one type of white blood cells)
low blood sodium levels
dehydration
increased blood triglyceride (fat) levels
rapid heart rate
gallbladder inflammation
decreased blood pressure, which may cause dizziness upon changing to an upright position
deep vein thrombosis (blood clots in the lower limbs)
sore throat
bloating
hypothyroidism
increased blood glucose levels
sensory disturbance
increased sweating
musculoskeletal pain
malaise
kidney inflammation
breast enlargement in men
changes in certain blood test results

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Nonpres

Keep this medicine out of sight and reach of children.
This medicine does not require any 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

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

What Nonpres looks like and contents of the pack
Nonpres 25 mg, film-coated tablets are: beige, round, biconvex, with an embossed "25" on one side.
Nonpres 25 mg, film-coated tablets are available in a pack containing 30 film-coated tablets.
Nonpres 50 mg, film-coated tablets are: beige, round, biconvex, with an embossed "50" on one side.
Nonpres 50 mg, film-coated tablets are available in a pack containing 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Poland Nonpres