Espiro

Package Leaflet: Information for the Patient

Espiro, 25 mg, Film-Coated Tablets

Espiro, 50 mg, Film-Coated Tablets

Eplerenone

Read the Package Leaflet Carefully Before Taking the Medication, 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Espiro and what is it used for
• 2. Important information 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 is Espiro and what is it 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 controls blood pressure and heart function. Increased levels of aldosterone can cause changes in the body that lead to heart failure. Espiro is used to treat heart failure to prevent the worsening of the disease and reduce the number of hospitalizations in cases of:

• previous heart attack - in combination with other heart failure medicines;
• persistent, mild symptoms despite previous treatment.

2. Important information before taking Espiro

When not to take Espiro:

• 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 help remove excess fluid from the body (potassium-sparing diuretics);
• if you have severe kidney problems;
• if you have severe liver problems;
• if you are taking medicines used to treat fungal infections (ketokonazol or itrakonazol);
• if you are taking medicines used to treat HIV (nelfinavir or ritonavir);
• if you are taking antibiotics used to treat bacterial infections (klarytromycyna or telitromycyna);
• if you are taking nefazodon, used to treat depression;
• if you are taking medicines used to treat certain heart or blood pressure conditions (so-called ACE inhibitors in combination with angiotensin II receptor antagonists (AIIRA)).

Warnings and precautions

Before taking Espiro, discuss with your doctor if:

• you have kidney or liver problems (see also "When not to take Espiro");
• you are taking lithium salts (usually used to treat manic-depressive disorder, also known as bipolar disorder);
• you are taking takrolimus or cyclosporine (used to treat skin disorders, such as psoriasis or eczema, and to prevent rejection of transplanted organs).

Children and adolescents

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

Espiro and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Do not take Espiro with the following medicines (see "When not to take Espiro"): itrakonazol or ketokonazol (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines against HIV), klarytromycyna, telitromycyna (used to treat bacterial infections), and nefazodon (used to treat depression), as these medicines may reduce the metabolism of Espiro and thus prolong its action in the body;

Tell your doctor about taking the following medicines:

• lithium (used to treat manic-depressive disorder, also known as bipolar disorder); Taking lithium with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) increased lithium levels in the blood, which may cause side effects such as loss of appetite, vision disturbances, fatigue, muscle weakness, and tremors.
• cyclosporine or takrolimus (used to treat skin disorders, such as psoriasis or eczema, and to prevent rejection of transplanted organs); These medicines may cause kidney problems and thus 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 cause kidney problems and thus increase potassium levels in the blood.
• trimetoprim (used to treat bacterial infections) may increase potassium levels in the blood;
• alpha-1-adrenolityki, such as prazosyna or alfuzosyna (used to treat high blood pressure and certain prostate disorders), may cause a sudden drop in blood pressure and dizziness when changing body position;
• tricyclic antidepressants, such as amitryptyline or amoksapina (used to treat depression), antipsychotic drugs (also known as neuroleptics), such as chloropromazyna or haloperydol (used to treat mental disorders), amifostyna (used in cancer chemotherapy), and baklofen (used to treat increased muscle tension); These medicines may cause a sudden drop in blood pressure and dizziness when changing body position.
• glucocorticosteroids, such as hydrokortyzon or prednizon (used to treat inflammatory conditions and certain skin diseases), and tetrakozaktyd (mainly used to diagnose and treat adrenal cortex disorders), may reduce the blood pressure-lowering effect of eplerenone;
• digoxin (used to treat heart disease); Taking digoxin with eplerenone may increase digoxin levels in the blood.
• warfarin (anticoagulant): if warfarin is administered, caution is required, as increased warfarin levels in the blood may affect the action of eplerenone;
• erythromycin (used to treat bacterial infections), sakwinawir (antiviral medicine against HIV), flukonazol (used to treat fungal infections), amiodaron, diltiazem, and verapamil (used to treat heart disease and high blood pressure) prolong the half-life of eplerenone, thus prolonging its action on the body;
• St. John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among other things, to treat epilepsy) may shorten the half-life of eplerenone, thus weakening its action.

Espiro with food and drink

Espiro 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 for advice before taking this medicine. The use of Espiro in pregnancy has not been studied. It is not known whether eplerenone passes into breast milk. Your doctor will decide whether to stop breastfeeding or stop the medicine, taking into account the benefit of breastfeeding for the baby and the benefit of the medicine for you.

Driving and using machines

During treatment with Espiro, dizziness may occur. If this happens, do not drive or operate machinery.

Espiro contains lactose monohydrate (a type of sugar) and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially 'sodium-free'.

3. How to take Espiro

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Espiro tablets can be taken with or without food. Swallow the tablets whole with a glass of water. Espiro is usually taken with other medicines used to treat heart failure, such as beta-adrenolityki. The usual starting dose is one 25 mg tablet once a day. After 4 weeks, your doctor may 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 recommend that you have your potassium levels checked before starting treatment with Espiro, within the first week of treatment, and after one month of treatment or after changing the dose. Depending on your potassium levels, your doctor may adjust the dose. In patients with mild kidney disease, treatment is started with the usual starting dose. In patients with moderate kidney disease, the starting dose is one 25 mg tablet every other day. Your doctor may adjust the dose, taking into account your potassium levels. In patients with severe kidney disease, the use of Espiro is contraindicated. In patients with mild or moderate liver disease, it is not necessary to adjust the starting dose. In cases of liver or kidney disease, it may be necessary to check potassium levels more frequently (see also "When not to take Espiro"). Elderly patients There is no need to adjust the starting dose. Children and adolescents The use of Espiro is not recommended.

What to do if you take more Espiro than you should

Inform your doctor or pharmacist immediately. The most likely symptoms of overdose are: low blood pressure (causing dizziness, blurred vision, weakness, sudden loss of consciousness) and high potassium levels in the blood (causing muscle cramps, diarrhea, nausea, dizziness, or headache).

What to do if you forget to take Espiro

If it is time for your next dose, skip the missed dose and take the next one at the right time. Otherwise, take the dose as soon as you remember, provided that it is more than 12 hours before your next dose. Then take your medicine as you always do. Do not take a double dose to make up for a forgotten dose.

What to do if you stop taking Espiro

It is important to take your medicine as recommended, unless your doctor tells you to stop. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following symptoms, seek medical help immediately:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing.These are symptoms of angioedema, a side effect that occurs in less than 1 in 100 patients.

Other side effects include:

• frequent side effects (occurring in less than 1 in 10 patients): increased potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache), dizziness, headache, fainting, increased cholesterol levels in the blood, insomnia (difficulty sleeping), cough, constipation, low blood pressure, heart problems (such as irregular heartbeat and heart failure), diarrhea, nausea, vomiting, kidney problems, rash, itching, weakness, muscle cramps and back pain, increased urea levels in the blood, increased creatinine levels in the blood, which may indicate kidney problems.

Uncommon side effects (occurring in less than 1 in 100 patients):

• increased levels of a certain type of white blood cell (eosinophilia)
• dehydration
• increased triglyceride levels in the blood
• low sodium levels in the blood
• infection
• gallbladder inflammation
• low blood pressure, which may cause dizziness when standing up
• blood clots (thrombosis) in the legs
• rapid heartbeat
• sore throat
• bloating
• hypothyroidism
• increased glucose levels in the blood
• reduced sensitivity to touch
• increased sweating
• muscle and bone pain
• general feeling of being unwell
• kidney inflammation
• breast enlargement in men
• changes in the results of some blood tests.

Reporting side effects

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

5. How to store Espiro

There are no special precautions for storage. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number. 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 Espiro contains

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

What Espiro looks like and contents of the pack

Espiro 25 mg are yellow, round, biconvex film-coated tablets, 6 mm in diameter. Espiro 50 mg are yellow, round, biconvex film-coated tablets with a single score line on one side, 8 mm in diameter. The score line on the tablet is only to facilitate breaking for ease of swallowing and not to divide into equal doses. The pack contains: 10, 20, 28, 30, 50, or 90 film-coated tablets in blisters and a cardboard box.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 3646101

Date of last revision of the leaflet: