Eplerenone + furosemide lek-am: detailed information

Package leaflet: Information for the patient

Eplerenonum + Furosemidum LEK-AM, 25 mg + 40 mg, tablets
Eplerenonum + Furosemidum LEK-AM, 50 mg + 40 mg, tablets
Eplerenonum + Furosemidum

Please read this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Eplerenonum + Furosemidum LEK-AM is and what it is used for
Important information before taking Eplerenonum + Furosemidum LEK-AM
How to take Eplerenonum + Furosemidum LEK-AM
Possible side effects
How to store Eplerenonum + Furosemidum LEK-AM
Contents of the pack and other information

1. What Eplerenonum + Furosemidum LEK-AM is and what it is used for

Eplerenonum + Furosemidum LEK-AM contains two active substances: eplerenone and furosemide.

Eplerenone 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. Elevated aldosterone levels may cause changes in the body leading to heart failure.
Furosemide belongs to a group of medicines called diuretics (water pills), which increase the amount of urine produced by the kidneys, helping to remove excess fluid from the body.

Eplerenonum + Furosemidum LEK-AM is used as replacement therapy in adult patients who are already receiving furosemide and eplerenone at doses corresponding to those in the combination product Eplerenonum + Furosemidum LEK-AM, to reduce the risk of cardiovascular mortality and morbidity in patients with stable left ventricular dysfunction (left ventricular ejection fraction ≤ 40%) and clinical signs of heart failure (oedema) following a recent myocardial infarction.

2. Important information before using Eplerenonum + Furosemidum LEK-AM

When not to use Eplerenonum + Furosemidum LEK-AM:

if the patient is allergic to eplerenone, furosemide, or any of the other ingredients of this medicine (listed in section 6),
if the patient is allergic to amiloride, sulfonamides, or sulfonamide derivatives such as sulfadiazine or co-trimoxazole,
if the patient has high blood potassium levels (hyperkalaemia),
if the patient has severe kidney disease,
if the patient has severe liver disease,
if the patient is taking drugs that remove excess fluid from the body (potassium-sparing diuretics),
if the patient is taking antifungal medicines (ketoconazole or itraconazole),
if the patient is taking antiviral drugs 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)),
if the patient has reduced intravascular volume or is dehydrated (with or without low blood pressure),
if the patient is not passing urine,
if the patient has kidney failure – in some types of kidney failure this medicine may still be used – the decision will be made by the doctor,
if the patient has severe liver disease with brain dysfunction (hepatic encephalopathy),
if the patient has pre-comatose or comatose states related to liver cirrhosis,
if the patient has electrolyte deficiency (e.g. low levels of potassium or sodium in the blood, detected in blood tests),
if the patient has a condition called Addison's disease, which may cause fatigue and weakness,
if the patient is taking other medicines that affect blood potassium levels (see "Eplerenonum + Furosemidum LEK-AM and other medicines"),
glycoside poisoning (e.g. digoxin toxicity),
porphyria,
if the patient is breastfeeding (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Before starting treatment with Eplerenonum + Furosemidum LEK-AM, discuss this with your
doctor, pharmacist, or nurse:

if the patient has kidney or liver disease (see also section "When not to use Eplerenonum + Furosemidum LEK-AM"),
if the patient is taking lithium salts (usually used to treat manic-depressive disorder, also known as bipolar disorder),
if the patient is taking tacrolimus or cyclosporine (used to treat skin conditions such as psoriasis or eczema, and to prevent rejection of transplanted organs),
if the patient is 65 years of age or older,
if the patient has difficulty passing urine,
if the patient has diabetes (high blood sugar levels),
if the patient is pregnant,
if the patient has gout, or impaired liver or kidney function,
if the patient has low blood pressure, regular monitoring of electrolyte levels is necessary, with appropriate dose adjustments, and if the patient experiences dizziness when standing up,
if the patient has low blood protein levels (hypoproteinaemia),
if the patient is taking risperidone,
if the patient has prostate gland disorders,
if the patient experiences dizziness or dehydration – these symptoms may occur if the patient has lost a lot of fluid due to vomiting, diarrhoea, or very frequent urination, or if the patient has difficulty drinking or eating,
if the patient will be taking non-steroidal anti-inflammatory drugs (NSAIDs) simultaneously,
if the patient is scheduled for a glucose tolerance test,
if the patient is taking other diuretic medicines,
if the patient has systemic lupus erythematosus (an autoimmune disease affecting the skin, bones, joints, and internal organs),
if the patient is elderly, taking other medicines that may lower blood pressure, or has other conditions that may increase the risk of low blood pressure.

If in doubt whether any of the above conditions apply to the patient, consult a doctor or pharmacist
before using Eplerenonum + Furosemidum LEK-AM.
Children and adolescents
The safety and efficacy of eplerenone in children and adolescents have not been established; therefore,
Eplerenonum + Furosemidum LEK-AM should not be used in this patient group.
Eplerenonum + Furosemidum LEK-AM and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines the patient plans to take.
Eplerenonum + Furosemidum LEK-AM may affect the action of the medicines listed below, and these
medicines may also affect the action of Eplerenonum + Furosemidum LEK-AM:

Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral drugs for HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression) – these medicines slow down the metabolism of Eplerenonum + Furosemidum LEK-AM, 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 such as ramipril, enalapril, perindopril, in combination with angiotensin II receptor antagonists (AIIRAs), used to treat high blood pressure, heart diseases, and certain kidney diseases – these may increase the risk of high blood potassium levels.
Lithium (usually used to treat manic-depressive disorder, also known as bipolar disorder) – taking lithium together with diuretics and ACE inhibitors (used to treat high blood pressure and heart diseases) may increase blood lithium levels, potentially causing adverse effects such as loss of appetite,
visual disturbances, fatigue, muscle weakness, and muscle tremors.
Cyclosporine or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent rejection of transplanted organs) – these may cause kidney dysfunction and thereby increase the risk of high blood potassium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs – some painkillers such as aspirin, ibuprofen, ketoprofen, or indomethacin, used to relieve pain, stiffness, and inflammation) – these 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.
Alpha1-adrenolytics such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate disorders) – may cause low blood pressure and dizziness upon changing to an upright position.
Tricyclic antidepressants such as amitriptyline or amoxapine (used to treat depression), antipsychotic medicines, also called neuroleptics, such as chlorpromazine or haloperidol (used to treat psychiatric disorders), amifostine (used in cancer chemotherapy), and baclofen (used in cases of increased muscle tone) – these may cause low blood pressure and dizziness upon changing to an upright position.
Glucocorticosteroids 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 Eplerenonum + Furosemidum LEK-AM.
Digoxin (used to treat heart diseases) – concomitant use with Eplerenonum + Furosemidum LEK-AM may increase blood digoxin levels. The doctor may adjust the dose.
Warfarin (an anticoagulant) – caution is required when using warfarin, as increased warfarin blood levels may interfere with the effect of Eplerenonum + Furosemidum LEK-AM on the body.
Erythromycin (used to treat bacterial infections), saquinavir (an antiviral drug used to treat HIV infection), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart diseases and high blood pressure) – slow down the metabolism of Eplerenonum + Furosemidum LEK-AM, thereby prolonging its effect.
St. John's wort (a herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy) – may accelerate the metabolism of Eplerenonum + Furosemidum LEK-AM, thereby weakening its effect.
Medicines such as losartan, candesartan, irbesartan (so-called angiotensin II receptor antagonists). The doctor may change the dose or advise discontinuation.
Medicines used for high blood pressure or heart disorders. The doctor may adjust the dose.
Other medicines used to treat high blood pressure and other medicines used to remove excess water from the body, known as diuretics, such as amiloride, spironolactone, acetazolamide, and metolazone.
Medicines that affect blood potassium levels. These include potassium supplements such as potassium chloride or certain diuretics.
Medicines used to treat heart rhythm disorders, such as amiodarone, disopyramide, flecainide,
lidocaine, sotalol, and mexiletine.
Sleeping and sedative medicines, e.g. chloral hydrate.
Medicines used in general anaesthesia to relax muscles during surgery. If undergoing anaesthesia, ensure that the doctor or nurse knows that the patient is taking furosemide.
Antidiabetic medicines – their effect may be weakened during furosemide use.
Theophylline – used in cases of wheezing or breathing difficulties.
Phenytoin – used to treat epilepsy – may weaken the effect of furosemide.
Medicines used to treat psychiatric disorders called psychoses, such as risperidone, amisulpride, sertindole, pimozide, and chlorpromazine. Pimozide should not be used with furosemide.
Platinum compounds.
Cisplatin – used to treat certain cancers.
Carbamazepine – used to treat epilepsy.
Aminoglutethimide – used to treat breast cancer.
Aldesleukin – used to prevent rejection of transplanted organs.
Moxisylyte – used to treat Raynaud's syndrome.
Medicines used to treat angina pectoris in inhaled or sublingual tablet form, such as glyceryl trinitrate or isosorbide dinitrate.
Methotrexate – used for skin, joint, or intestinal diseases.
Carbenoxolone and sucralfate – used to treat oesophageal and gastric ulcers.
Reboxetine, amitriptyline, and phenelzine – used to treat depression.
Amphotericin – used in fungal infections, especially with prolonged administration.
Corticosteroids – used in inflammatory conditions, such as prednisolone.
Atomoxetine – used to treat attention deficit hyperactivity disorder (ADHD).
Muscle relaxants such as tizanidine.
Antihistamines used to treat allergies, such as cetirizine.
Alprostadil – used to treat erectile dysfunction in men.
Estrogens and drospirenone – used as contraceptives or in hormone replacement therapy (HRT).
Liquorice – often contained in cough medicines, especially when taken in large doses.
Probenecid (used with other medicines in HIV infection).
Medicines used in infections, such as gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin, or cephalosporins in high doses.
Substances used as injections before X-ray examinations (contrast agents used in radiology).
Medicines used for constipation (laxatives), used long-term, such as bisacodyl or senna.
Anti-asthmatic medicines administered in high doses, such as salbutamol, terbutaline sulphate, salmeterol, formoterol, or bambuterol.
Medicines used for nasal congestion, such as ephedrine and xylometazoline.
Potassium salts used in cases of low blood potassium levels.
Medicines used to treat Parkinson's disease, such as levodopa.
Other diuretics (diuretics), such as bendroflumethiazide. The doctor may adjust the dose.
High doses of furosemide administered with levothyroxine may initially lead to
a transient increase in free thyroid hormone levels, followed by a general
decrease in total thyroid hormone concentration.
Eplerenonum + Furosemidum LEK-AM with food and drink
Eplerenonum + Furosemidum LEK-AM should preferably be taken on an empty stomach, with the tablet swallowed with a large amount of liquid. During treatment with Eplerenonum + Furosemidum LEK-AM, alcohol consumption should be avoided, as it may lower blood pressure.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine. The effect of
Eplerenonum + Furosemidum LEK-AM during pregnancy has not been evaluated in humans.
One of the active substances in this medicine, furosemide, may pass into breast milk in small amounts.
Therefore, breastfeeding should not be continued during treatment with this medicine.
Consult a doctor whether to discontinue breastfeeding or to stop using the medicine.
Driving and operating machinery
After taking Eplerenonum + Furosemidum LEK-AM, symptoms such as reduced attention,
dizziness, and blurred vision may occur. In such cases, the patient should not drive or
operate machinery.
Eplerenonum + Furosemidum LEK-AM contains lactose monohydrate and sodium
Eplerenonum + Furosemidum LEK-AM contains lactose monohydrate (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a
doctor before taking this medicine.
Eplerenonum + Furosemidum LEK-AM contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Eplerenonum + Furosemidum LEK-AM

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Eplerenonum + Furosemidum LEK-AM tablets are best taken on an empty stomach, with a large
amount of fluid.
Eplerenonum + Furosemidum LEK-AM is a fixed-dose combination product that may only be used
in patients whose maintenance doses have already been established based on individual components
(furosemide and eplerenone administered as separate products), and who do not require dose
adjustments. If this fixed-dose combination causes adverse reactions indicating the need for dose
re-adjustment, the product should be discontinued and the doctor should determine an appropriate
dose for the patient using furosemide and eplerenone as separate products.
To allow individual dose adjustment, formulations containing 25 mg eplerenone and 40 mg
furosemide, and 50 mg eplerenone and 40 mg furosemide are available.
The maximum dose of eplerenone is 50 mg per day.
The recommended maintenance dose is one tablet containing 50 mg eplerenone and 40 mg furosemide
once daily.
During treatment, your doctor may recommend monitoring blood potassium levels, and if dose
adjustment becomes necessary depending on blood potassium levels, your doctor may adjust the dose
using furosemide and eplerenone as separate products.
If the patient has mild or moderate kidney disease, the doctor may recommend dose adjustment,
taking into account blood potassium levels, using furosemide and eplerenone as separate products.
Eplerenonum + Furosemidum LEK-AM is contraindicated in patients with severe kidney disease.
In case of liver or kidney disorders, more frequent monitoring of blood potassium levels may be
necessary (see also “When not to use Eplerenonum + Furosemidum LEK-AM”).

Use in children and adolescents:
Use of Eplerenonum + Furosemidum LEK-AM is not recommended in children and adolescents.

Use in elderly patients:
The doctor may recommend periodic monitoring of blood potassium levels, and if dose adjustment
becomes necessary depending on blood potassium levels, the doctor may adjust the dose using
furosemide and eplerenone as separate products.

Use in patients with renal impairment:
In patients with mild or moderate renal impairment, the doctor may recommend periodic monitoring of
blood potassium levels, and if dose adjustment becomes necessary depending on blood potassium
levels, the doctor may adjust the dose using furosemide and eplerenone as separate products.

Use in patients taking other medicinal products:
When used concomitantly with weak or moderate CYP3A4 inhibitors, e.g. amiodarone, diltiazem, or
verapamil, the maintenance dose should not exceed 25 mg + 40 mg once daily.

Use of a higher than recommended dose of Eplerenonum + Furosemidum LEK-AM
If a higher than recommended dose of Eplerenonum + Furosemidum LEK-AM is taken, or if any dose
is taken by a child, contact a doctor immediately or go to the emergency department of the nearest
hospital, even if no symptoms are present. Bring the medicine packaging with you so the doctor knows
which medicine was taken. The most likely symptoms of overdose include: low blood pressure (causing
dizziness, blurred vision, weakness, fainting), hyperkalaemia (high potassium levels in blood), causing
muscle cramps, diarrhoea, nausea, dizziness or headache, irregular heartbeat, blood clots (causing pain
and swelling in the affected body part), disorientation, inability to concentrate, lack of emotion or
interest in anything. Kidney or blood disorders may also occur.

Missed dose of Eplerenonum + Furosemidum LEK-AM
If it is almost time for the next dose, skip the missed dose and take the next tablet 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 Eplerenonum + Furosemidum LEK-AM
It is important to take Eplerenonum + Furosemidum LEK-AM as directed, unless your doctor advises
stopping treatment.

If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, stop taking the medicine and consult a doctor immediately:

swelling of the face, tongue or throat, difficulty swallowing, urticaria and breathing difficulties (these are symptoms of angioedema, an adverse reaction that is not common).
allergic reactions such as itching, skin rash with intense itching and urticaria, fever, photosensitivity, severe allergic reaction with (high) fever, red skin spots, joint pain and (or) eye inflammation, severe acute allergic reaction accompanied by fever, skin blisters/skin peeling and petechiae due to skin hemorrhage.
acute pancreatitis, characterized by severe upper abdominal pain radiating to the back.

Other possible adverse reactions:
Inform your doctor if any of the following symptoms worsen or persist for longer than a few days.
Common (may occur in less than 1 in 10 people)

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

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

kidney inflammation,
infection,
sore throat,
eosinophilia (increased number of one type of white blood cells),
thrombocytopenia,
hypothyroidism,
low sodium levels in blood,
dehydration, dryness of oral mucosa, thirst,
increased triglyceride (fat) levels in blood,
impaired touch sensation,
visual disturbances,
increased heart rate,
thrombosis (blood clot formation) in the lower limbs,
reduced blood pressure, possibly causing dizziness upon changing to an upright position,
bloating,
angioedema (symptoms may include swelling of the face, tongue or throat, difficulty swallowing, urticaria and breathing difficulties),
increased sweating,
musculoskeletal pain,
gallbladder inflammation,
gynecomastia (breast enlargement in males),
general malaise,
increased glucose levels in blood,
changes in certain blood test results (e.g. transient increase in creatinine and urea levels),
abnormal platelet count associated with bruising and tendency to bleed,
photosensitivity,
involuntary urine leakage,
in elderly patients – reduced intravascular volume, fluid deficiency and blood concentration, which may lead to thrombus formation,
deafness (sometimes irreversible).

Rare (may occur in less than 1 in 1000 people)

abnormal blood cell count (leukopenia), associated with increased susceptibility to infections,
increased number of certain white blood cells (eosinophils) in blood,
bone marrow suppression,
sensation of skin crawling, itching or tingling without cause,
life-threatening loss of consciousness,
hearing disorders and tinnitus, which are usually transient,
vasculitis,
acute kidney failure,
kidney inflammation with blood in urine, fever and back flank pain – in case of urinary tract obstruction, urine retention may occur,
if the patient has bladder dysfunction, enlarged prostate gland or ureteral narrowing, acute urinary retention may occur,
shock (severe drop in blood pressure, extreme pallor, restlessness, rapid weak pulse, cold moist skin, impaired consciousness) due to sudden, significant vasodilation caused by hypersensitivity to certain substances,
fever.

Very rare (may occur in less than 1 in 10,000 people)

anemia (condition characterized by deficiency of red blood cells),
very severe blood disorders (leukopenia) accompanied by sudden high fever, severe sore throat and oral ulcers,
some liver function disorders,
increased activity of certain liver enzymes. During treatment with furosemide, levels of certain blood lipids (cholesterol and triglycerides) may increase, but usually return to normal within 6 months.

Frequency not known (frequency cannot be estimated from available data)

acute generalized exanthematous pustulosis (acute drug rash with fever),
dizziness, fainting and loss of consciousness (caused by symptomatic hypotension).

Reporting of adverse reactions
If any adverse reactions occur, including those 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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Eplerenonum + Furosemidum LEK-AM

Keep the medicine out of the sight and reach of children.
Store below 30°C. Keep the blister in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister following EXP:.
The expiry date refers to the last day of the stated 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 Eplerenonum + Furosemidum LEK-AM contains
The active substances are:

Eplerenonum + Furosemidum LEK-AM, 25 mg + 40 mg, tablets: each tablet contains 25 mg eplerenone and 40 mg furosemide
Eplerenonum + Furosemidum LEK-AM, 50 mg + 40 mg, tablets: each tablet contains 50 mg eplerenone and 40 mg furosemide

The other ingredients are: lactose monohydrate, microcrystalline cellulose type 101, microcrystalline cellulose type 102, hydroxypropylcellulose 100 cPs, sodium croscarmellose, talc, magnesium stearate, and sodium lauryl sulfate.

What Eplerenonum + Furosemidum LEK-AM looks like and contents of the pack
Eplerenonum + Furosemidum LEK-AM, 25 mg + 40 mg, tablets: white or almost white, biconvex, capsule-shaped tablets, 20 mm x 8 mm in size, with the imprint “25/40” on one side. Dark specks may be present on the tablet surface.
Eplerenonum + Furosemidum LEK-AM, 50 mg + 40 mg, tablets: white or almost white, biconvex, oval tablets, 19 mm x 9.6 mm in size, with the imprint “50/40” on one side. Dark specks may be present on the tablet surface.
The tablets are packed in PVC/PVDC/Aluminium blisters and placed in a cardboard box.
Pack sizes contain 30, 60 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
ul. Ostrzykowizna 14A
05-170 Zakroczym
Tel.: (22) 785 27 60