EPLERENONE STADA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eplerenona Stada 50 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What you need to know before you take Eplerenona Stada
2. How to take Eplerenona Stada

1. Possible side effects
2. Storage of Eplerenona Stada
3. Contents of the pack and further information

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

Eplerenone belongs to a group of medicines called selective aldosterone blockers. These blockers inhibit the action of aldosterone, a substance produced by the body that controls blood pressure and cardiac function. High levels of aldosterone can cause changes in your body that lead to heart failure.

Eplerenone is used to treat heart failure to prevent worsening and reduce hospitalization if you have:

1. a recent myocardial infarction, in combination with other medications used to treat your heart failure or

1. mild persistent symptoms, despite treatment you have been receiving so far.

2. What you need to know before you take Eplerenona Stada

Do not take Eplerenona Stada

• 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 from groups that help eliminate excess fluid in 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 (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 to treat depression
• if you are taking medications used to treat certain heart diseases or high blood pressure (such as ACE inhibitors and angiotensin receptor antagonists) at the same time.

Warnings and precautions

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

• if you have kidney or liver disease (see "Do not take Eplerenona Stada")
• if you are taking lithium (normally 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 organ rejection after transplantation)

Children and adolescents

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

Using Eplerenona Stada with other medicines

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

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for HIV treatment), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression), as these medicines reduce the metabolism of eplerenone and thus prolong its effect in the body.
• Potassium-sparing diuretics (medicines that help eliminate excess fluid in the body) or potassium supplements (salt tablets), as these medicines increase the risk of high levels of potassium in the blood.
• ACE inhibitors and angiotensin receptor antagonists at the same time (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medicines may increase the risk of high levels of potassium in the blood.
• Lithium (normally used for manic-depressive disorders, also called bipolar disorder). The use of lithium with diuretics and ACE inhibitors has been shown to cause high levels of lithium in the blood, which can cause the following adverse reactions: loss of appetite, vision changes, fatigue, muscle weakness, and muscle cramps.
• Cyclosporine or tacrolimus (used to treat skin diseases such as psoriasis or eczema and to prevent organ rejection after transplantation). These medicines can cause kidney problems and thus increase the risk of high levels of potassium in the blood.
• Non-steroidal anti-inflammatory medicines (NSAIDs - certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines can cause kidney problems and thus increase the risk of high levels of potassium in the blood.
• Trimethoprim (used to treat bacterial infections) may increase the risk of high levels of potassium in the blood.
• Alpha-1 blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate diseases), may lead to a decrease in blood pressure and dizziness when standing up.
• Tricyclic antidepressants such as amitriptyline or amoxapine (for the treatment of depression), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (for the treatment of psychiatric disorders), amifostine (used during cancer chemotherapy), and baclofen (used to treat muscle spasms). These medicines may lead to a decrease in blood pressure and dizziness when standing up.
• Corticosteroids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin diseases), and tetracosactide (mainly used to diagnose and treat adrenal cortex diseases), may reduce the blood pressure-lowering effect of eplerenone.
• Digoxin (used in the treatment of heart diseases). Blood levels of digoxin may increase when taken with eplerenone.
• Warfarin (an anticoagulant medicine): Caution is required when administering warfarin doses, as high levels of warfarin in the blood may affect the effect of eplerenone in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for HIV treatment), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for the treatment of heart problems and high blood pressure), as they reduce the metabolism of eplerenone, thus prolonging its effect in the body.
• Hypericum perforatum or St. John's Wort (a medicinal plant), 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 Eplerenona Stada with food and drinks

Eplerenone 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 or pharmacist for advice before taking this medicine.

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

It is not known whether eplerenone is excreted in 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 happens, do not drive or operate machinery.

This medicine contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Eplerenona Stada

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of 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 given together with other medicines for heart failure, for example, beta-blockers. The usual initial dose is one 25 mg tablet once a day, increasing later after about 4 weeks to 50 mg daily (one 50 mg tablet or two 25 mg tablets). The maximum dose regimen is 50 mg per day.

Potassium blood levels should be determined before starting treatment with eplerenone, during the first week, and after one month of starting treatment or after a dose change. Your doctor may adjust the dose based on your potassium blood levels.

If you have mild kidney problems, you should start treatment with a 25 mg tablet per day, and if you have moderate kidney problems, you should start treatment with a 25 mg tablet every other day. These doses may be adjusted if your doctor indicates and according to your potassium blood levels. Eplerenone is not recommended in patients with severe kidney disease.

No initial dose adjustment is necessary in patients with mild to moderate liver problems. If you have any liver or kidney disease, you may need to have potassium blood levels determined more frequently (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 too much medicine, the most likely symptoms will be low blood pressure (manifested as dizziness, blurred vision, weakness, sudden 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 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 dose at the scheduled time. Otherwise, take the dose as soon as you remember, provided that more than 12 hours remain until the next dose. Resume taking your medicine as usual. Do not take a double dose to make up for missed doses.

If you stop taking Eplerenona Stada

It is important to keep taking eplerenone as your doctor has told you, unless your doctor tells you to stop. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 any of the following happen:

Seek medical attention immediately

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

These are symptoms of angioedema, a rare side effect (affecting up to 1 in 100 people).

Other reported side effects include:

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

• high levels of potassium in the blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• dizziness
• fainting
• high levels of cholesterol in the blood
• insomnia (difficulty sleeping)
• headache
• heart problems, such as irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasms
• increased levels of urea in the blood
• increased levels of creatinine in the blood, which may indicate kidney problems

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

• infection
• eosinophilia (an increase in certain white blood cells)
• low levels of sodium in the blood
• dehydration
• high levels of triglycerides (fats) in the blood
• rapid heartbeat
• inflammation of the gallbladder
• low blood pressure that may cause dizziness when standing up
• blood clots in the legs
• sore throat
• flatulence
• underactive thyroid
• increased blood glucose
• decreased sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in certain blood tests.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenona 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of containers and medicines no longer needed. This will help protect the environment.

6. Contents of the pack and further information

Composition of Eplerenona Stada

The active substance of Eplerenona Stada film-coated tablets is eplerenone. Each tablet contains 50 mg of eplerenone.

Eplerenona Stada 50 mg also contains the following ingredients in the tablet core: lactose monohydrate, microcrystalline cellulose (type 101), croscarmellose sodium, hypromellose (Type 2910), microcrystalline cellulose (type 102), sodium lauryl sulfate, talc, and magnesium stearate.

Eplerenona Stada 50 mg contains the following ingredients in the Opadry II white OY-L-28900 coating: lactose monohydrate, hypromellose (Type 2910), titanium dioxide (E171), macrogol 4000.

Appearance of Eplerenona Stada and contents of the pack

The Eplerenona Stada 50 mg tablet is a white to almost white, round, biconvex tablet, marked "CG4" on one side of the tablet and smooth (unmarked) on the other side.

Eplerenona Stada 50 mg film-coated tablets EFG are presented in cartons 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 last revision of this leaflet:August 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/