Espiro

Package leaflet: Information for the patient

Espiro, 25 mg, film-coated tablets
Espiro, 50 mg, film-coated tablets
Eplerenonum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as 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 pass it on to others. It may harm someone else, 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.

Contents of the leaflet

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

1. What Espiro is and what it is used for

Espiro 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 levels of aldosterone may cause changes in the body leading to heart failure.
Espiro is a medicine used in the treatment of heart failure to prevent disease progression and reduce the number of hospitalizations in cases of:

• Previous heart attack – in combination with other medicines used for heart failure;
• Persistent, mild symptoms despite ongoing treatment.

2. Important information before using Espiro

When not to use Espiro:

• if the patient is allergic to eplerenone or to any of the other ingredients of this medicine (listed in section 6);
• if there is increased potassium levels in the blood (hyperkalemia);
• if the patient is taking medicines that help eliminate excess fluid from the body (potassium-sparing diuretics);
• if there are severe kidney function disorders;
• if there is severe liver dysfunction;
• if the patient is taking antifungal medicines (ketoconazole or itraconazole);
• if the patient is taking medicines used for HIV infections (nelfinavir or ritonavir);
• if the patient is taking antibiotics used for bacterial infections (clarithromycin or telithromycin);
• if the patient is taking nefazodone, used in the treatment of depression;
• if the patient is simultaneously taking medicines used in the treatment of certain heart diseases or hypertension (so-called angiotensin-converting enzyme inhibitors (ACE inhibitors) in combination with angiotensin II receptor antagonists (AIIRAs)).

Warnings and precautions
Before starting treatment with Espiro, discuss with your doctor if:

• there is kidney or liver dysfunction (see also section "When not to use Espiro");
• the patient is taking lithium salts (usually used in bipolar disorder);
• the patient is taking tacrolimus or cyclosporine (used in the treatment of skin disorders such as psoriasis or eczema, and to prevent rejection reactions of transplanted organs).

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

Espiro and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Espiro with the following medicines (see section "When not to use Espiro"):

• itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for HIV), clarithromycin, telithromycin (used to treat bacterial infections), and nefazodone (used to treat depression), because these medicines may reduce the metabolism of Espiro and thereby prolong its action in the body;
• potassium-sparing diuretics (medicines that help remove excess fluid from the body) and potassium supplements. These medicines increase potassium levels in the blood;
• medicines used to treat certain heart diseases or hypertension (so-called angiotensin-converting enzyme inhibitors (ACE inhibitors) used together with angiotensin II receptor antagonists (AIIRAs), used to treat arterial hypertension, heart diseases, and certain kidney diseases), because they may increase potassium levels in the blood.

Inform your doctor if you are taking any of the following medicines:

• lithium (usually used in the treatment of bipolar disorder); Concurrent use of lithium with diuretics and angiotensin-converting enzyme (ACE) inhibitors (used to treat arterial hypertension and heart diseases) has increased lithium levels in the blood, which may cause adverse effects such as loss of appetite, visual disturbances, fatigue, muscle weakness, and muscle tremors;
• cyclosporine or tacrolimus (used in the treatment of skin disorders such as psoriasis or eczema and to prevent rejection reactions of transplanted organs); These medicines may cause kidney dysfunction and thereby increase potassium levels in the blood;
• non-steroidal anti-inflammatory drugs (NSAIDs—painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation); These medicines may lead to kidney dysfunction and thereby increase potassium levels in the blood;
• trimethoprim (used to treat bacterial infections) may increase potassium levels in the blood;
• alpha-1-adrenergic blockers such as prazosin or alfuzosin (used to treat arterial hypertension and certain prostate disorders) may cause sudden drop in blood pressure and dizziness upon standing;
• 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 psychiatric disorders), amifostine (used in cancer chemotherapy), and baclofen (used in cases of increased muscle tone); These medicines may cause sudden drop in blood pressure and dizziness upon standing;
• glucocorticosteroids such as hydrocortisone or prednisone (used to treat inflammatory conditions and certain skin diseases) and tetracosactide (used mainly in diagnosing and treating adrenal cortex disorders) may reduce the blood pressure-lowering effect of eplerenone;
• digoxin (used to treat heart diseases); Concurrent use with eplerenone may increase digoxin levels in the blood;
• warfarin (an anticoagulant medicine): caution is required if warfarin is administered, because increased warfarin levels in the blood may interfere with the effect of eplerenone on the body;
• erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine used to treat HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart diseases and arterial hypertension) may prolong the half-life of eplerenone, thereby extending its action in the body;
• St. John’s wort (a herbal remedy), rifampicin (an antibiotic used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, in epilepsy treatment) may shorten the half-life of eplerenone and thereby weaken its effect.

Espiro with food and drink
Espiro may be taken with or without food.

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 her doctor before using this medicine.
The use of Espiro during pregnancy has not been studied.
It is unknown whether eplerenone passes into human breast milk. The doctor should decide whether to discontinue breastfeeding or discontinue the medicine, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery
Dizziness may occur during treatment with Espiro. If dizziness occurs, do not drive or operate machinery.

Espiro contains lactose monohydrate (a type of sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Espiro

This medicine should always be taken as directed by a physician. If in doubt, consult a doctor or pharmacist.
Espiro tablets may be taken with or without food. Swallow the tablets whole with a large amount of water.
Espiro is usually taken together with other medicines used to treat heart failure, e.g. beta-blockers.
The usual starting dose is one 25 mg tablet once daily.
After 4 weeks, the doctor will increase 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 recommend measuring blood potassium levels before starting Espiro treatment, during the first week of treatment, and one month after starting treatment or after any dose adjustment.
Depending on the blood potassium level, the doctor may adjust the dose.
In patients with mild kidney disease, treatment is usually initiated with the standard starting dose.
In patients with moderate kidney disease, the starting dose is one 25 mg tablet administered every other day. The doctor may adjust the dose based on blood potassium levels.
In patients with severe kidney disease, use of Espiro is contraindicated.
In patients with mild or moderate liver disease, no adjustment of the starting dose is necessary.
In case of liver or kidney disease, more frequent monitoring of blood potassium levels may be required (see also section "When not to take Espiro").

Elderly patients
No adjustment of the starting dose is necessary.

Children and adolescents
Use of Espiro is not recommended.

Taking more Espiro than prescribed
Inform 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 increased blood potassium levels (causing muscle cramps, diarrhoea, nausea, dizziness, or headache).

Missing a dose of Espiro
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 continue taking the medicine as usual.
Do not take a double dose to make up for a missed dose.

Stopping Espiro treatment
It is important to take this medicine as prescribed, unless the doctor advises stopping treatment.
If you have any further questions about how to use 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, seek medical help immediately:

• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria and breathing difficulties. These are symptoms of angioedema, an adverse reaction occurring not commonly (in less than 1 in 100 patients).

Other adverse reactions include:
Common adverse reactions (occur in less than 1 in 10 patients):

• increased blood potassium levels (symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache)
• dizziness
• headache
• fainting
• increased blood cholesterol levels
• insomnia (difficulty sleeping)
• cough
• constipation
• low blood pressure
• heart disorders, e.g. irregular heartbeat and heart failure
• diarrhoea
• nausea
• vomiting
• kidney function disorders
• rash
• itching
• fatigue
• muscle cramps and back pain
• increased blood urea levels
• increased blood creatinine levels, which may indicate kidney function disorders.

Uncommon adverse reactions (occur in less than 1 in 100 patients):

• increased number of a specific type of white blood cells (eosinophilia)
• dehydration
• increased blood triglyceride (fat) levels
• low blood sodium levels
• infection
• gallbladder inflammation
• low blood pressure, possibly causing dizziness upon standing
• blood clot (thrombosis) in the lower limbs
• rapid heartbeat
• sore throat
• bloating
• hypothyroidism
• increased blood glucose levels
• decreased sensitivity to touch
• excessive sweating
• muscle and bone pain
• malaise
• kidney inflammation
• breast enlargement in men
• changes in results of certain blood tests.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 to provide more information on the safety of this medicine.

5. How to store Espiro

No special storage conditions are required.
The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the specified month.
The label on the packaging indicates the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Espiro contains

• The active substance is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.
• Other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose 15cP, magnesium stearate, sodium lauryl sulfate. The tablet coating contains: hypromellose 6 cP, macrogol 3350, titanium dioxide (E 171), monohydrate lactose, triacetin, yellow iron oxide (E 172).

What Espiro looks like and contents of the pack
Espiro 25 mg are yellow, film-coated, round, biconvex tablets with a diameter of 6 mm.
Espiro 50 mg are yellow, film-coated, round, biconvex tablets with a single break line on one side and a diameter of 8 mm. The break line is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dose division.
Packaging contains:
10, 20, 28, 30, 50 or 90 film-coated tablets in blisters packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański, Poland
tel. + 48 22 3646101