Eplerenone Stada 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eplerenona Stada 25 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Eplerenona Stada is and what it is used for

2. What you need to know before taking Eplerenona Stada

3. How to take Eplerenona Stada

4. Possible side effects

5. How to store Eplerenona Stada

6. Contents of the pack and other information

1. What Eplerenona Stada is and what it is used for

Eplerenone belongs to a group of medicines known as selective aldosterone blockers. These blockers inhibit 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 your body that can lead to heart failure.

Eplerenone is used to treat heart failure to prevent worsening of the condition and reduce hospitalization in patients who have:

1. recently suffered a myocardial infarction, in combination with other medicines used to treat heart failure, or

2. persistent mild symptoms despite ongoing treatment.

2. What you need to know before starting to take Eplerenone Stada

Do not take Eplerenone Stada

• if you are allergic to eplerenone or to any of the other ingredients of this medicine (listed in section 6)
• if you have high levels of potassium in your blood (hyperkalaemia)
• if you are taking medicines from groups that help your body eliminate excess fluid (potassium-sparing diuretics)
• if you have severe renal impairment
• if you have severe hepatic impairment
• if you are taking medicines used to treat fungal infections (ketoconazole or itraconazole)
• if you are taking medicines used to treat HIV infection (ritonavir or nelfinavir)
• if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin)
• if you are taking nefazodone for depression
• if you are taking, at the same time, medicines used to treat certain heart conditions or hypertension (such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists (ARA)).

W arnings and precautions

Consult your doctor or pharmacist before starting to take Eplerenone Stada.

• if you have kidney or liver disease (see “Do not take Eplerenone Stada”)
• if you are taking lithium (commonly used for manic-depressive disorders, also called bipolar disorder)
• if you are taking tacrolimus or cyclosporine (used to treat skin diseases 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.

Taking Eplerenone Stada with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for treating HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the metabolism of eplerenone, thereby prolonging its effect in the body.
• Potassium-sparing diuretics (medicines that help eliminate excess fluid from the body) or potassium supplements (salt tablets), as these medicines increase the risk of developing high potassium levels in the blood.
• Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists (ARA) taken together (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medicines may increase the risk of high potassium levels in the blood.
• Lithium (commonly used for manic-depressive disorders, also called bipolar disorder). The use of lithium together with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) has been shown to cause excessively high levels of lithium in the blood, which may lead to the following adverse reactions: loss of appetite, vision disturbances, fatigue, muscle weakness, and muscle cramps.
• Cyclosporine or tacrolimus (used to treat skin diseases such as psoriasis or eczema and to prevent rejection of transplanted organs). These medicines may cause kidney problems and thus increase the risk of high potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs – certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines may cause kidney problems and thus increase the risk of high potassium levels in the blood.
• Trimethoprim (used to treat bacterial infections) may increase the risk of high potassium levels in the blood.
• Alpha-1 blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions), may lead to a drop in blood pressure and dizziness upon standing.
• Tricyclic antidepressants such as amitriptyline or amoxapine (for treatment of depression), antipsychotics (known as neuroleptics) such as chlorpromazine or haloperidol (for treatment of psychiatric disorders), amifostine (used during cancer chemotherapy), and baclofen (used to treat muscle spasms). These medicines may lead to a drop in blood pressure and dizziness upon standing.
• Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin diseases), and tetracosactide (mainly used to diagnose and treat adrenal cortex disorders), may reduce the blood pressure-lowering effect of eplerenone.
• Digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with eplerenone.
• Warfarin (an anticoagulant medicine): Caution is required when administering warfarin, as high levels of warfarin in the blood may affect how eplerenone acts in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for treating HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart problems and high blood pressure) may reduce the metabolism of eplerenone, thereby prolonging its effect in the body.
• Hypericum perforatum (St. John's wort, a herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy) may increase the metabolism of eplerenone and thus reduce its effect.

Taking Eplerenone Stada with food and drink

Eplerenone may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The effect of eplerenone during pregnancy has not been evaluated in humans.

It is unknown whether eplerenone is excreted in human breast milk. Your doctor will decide with you whether to discontinue treatment or breastfeeding.

Driving and using machines

After taking eplerenone, you may feel dizzy. If this occurs, do not drive or operate machinery.

This medicine contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Eplerenona Stada

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Eplerenone tablets can be taken with or without food. Swallow the tablets whole with plenty of water.

Eplerenone is usually administered together with other medicines for heart failure, for example, beta-blockers. The usual starting dose is one 25 mg tablet once daily, increasing after approximately 4 weeks to 50 mg daily (one 50 mg tablet or two 25 mg tablets). The maximum dosage regimen is 50 mg per day.

Blood potassium levels should be measured before starting treatment with eplerenone, during the first week, and one month after starting treatment or after any dose adjustment. Your doctor may adjust the dose based on your blood potassium levels.

If you have mild renal impairment, treatment should be initiated with one 25 mg tablet daily. If you have moderate renal impairment, treatment should be initiated with one 25 mg tablet every other day. These doses may be adjusted, as directed by your doctor, according to your blood potassium levels. Eplerenone is not recommended in patients with severe renal disease.

No initial dose adjustment is necessary in patients with mild to moderate hepatic impairment. If you have any liver or kidney disease, you may require more frequent blood potassium monitoring (see also "Do not take Eplerenona Stada").

In elderly patients: no initial dose adjustment is required.

In children and adolescents: eplerenone is not recommended.

If you take more Eplerenona Stada than you should

If you take more eplerenone than you should, inform your doctor or pharmacist immediately. If you have taken an overdose, the most likely symptoms are low blood pressure (manifested as dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalemia, high levels of potassium in the blood (manifested by muscle cramps, diarrhea, nausea, dizziness, or headache).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eplerenona Stada

If it is almost time for your next dose, skip the missed dose and take the next tablet at the scheduled time. Otherwise, take the missed tablet as soon as you remember, provided that more than 12 hours remain before the next scheduled dose. Resume your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Eplerenona Stada

It is important to continue taking eplerenone as directed, unless your doctor tells you to stop treatment. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If any of the following occur:

Seek immediate medical attention

• swelling of the face, tongue or throat
• difficulty swallowing
• blistering and difficulty breathing

These are symptoms of angioedema, an uncommon adverse effect (affecting up to 1 in 100 people).

Other reported adverse effects include:

Common adverse effects (may affect up to 1 in 10 people):

• elevated blood potassium levels (these symptoms include muscle cramps, diarrhea, nausea,
• dizziness or headache)
• dizziness
• fainting
• elevated blood cholesterol levels
• insomnia (difficulty sleeping)
• headache
• heart-related discomfort, for example, irregular heartbeats and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasm
• increased blood urea levels
• elevated blood creatinine levels, which may indicate kidney problems

Uncommon adverse effects (may affect up to 1 in 100 people):

• infection
• eosinophilia (increase in certain white blood cells)
• low blood sodium levels
• dehydration
• elevated blood triglyceride levels (fats)
• rapid heartbeat
• inflammation of the gallbladder
• drop in blood pressure that may cause dizziness upon standing
• thrombosis (blood clot) in the legs
• sore throat
• flatulence
• underactive thyroid
• increased blood glucose levels
• reduced sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in certain blood test results

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Stada

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 (EXP) stated on the packaging and outer carton. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenona Stada

The active substance in Eplerenona Stada film-coated tablets is eplerenone. Each tablet contains 25 mg of eplerenone.

Eplerenona Stada 25 mg also contains the following excipients in the tablet core: monohydrate lactose, microcrystalline cellulose (type 101), sodium croscarmellose, hypromellose (Type 2910), microcrystalline cellulose (type 102), sodium lauryl sulfate, talc, and magnesium stearate.

Eplerenona Stada 25 mg contains the following excipients in the coating Opadry II white OY-L-28900: monohydrate lactose, hypromellose (Type 2910), titanium dioxide (E171), macrogol 4000.

Appearance of Eplerenona Stada and contents of the pack

Eplerenona Stada 25 mg is a white to almost white, round, biconvex tablet, marked "CG3" on one side and smooth (unmarked) on the other side.

Eplerenona Stada 25 mg film-coated tablets EFG are supplied in cardboard boxes with PVC/aluminum blisters containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern, Barcelona

Spain

[email protected]

Manufacturer

Laboratorios LICONSA S.A.

Avenida Miralcampo 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Date of the most recent revision of this package leaflet: August 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/