EPLERENONE ALTER 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eplerenona Alter 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

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

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

Eplerenona Alter 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 controls blood pressure and cardiac function. High levels of aldosterone can cause changes in your body that lead to heart failure.

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

1. a recent myocardial infarction, in combination with other medicines used to treat your heart failure or
2. mild persistent symptoms, despite the treatment you have been receiving so far.

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

Do not take Eplerenona Alter

• 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 your blood (hyperkalemia)
• if you are taking medicines that help your body get rid of excess fluid (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 infections (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 medicines 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 Alter

• if you have kidney or liver disease (see also "Do not take Eplerenona Alter")
• if you are taking lithium (used to treat manic-depressive disorders, also called bipolar disorder)
• if you are taking tacrolimus or cyclosporin (used to treat skin diseases such as psoriasis or eczema and to prevent organ transplant rejection)

Children and adolescents

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

Taking Eplerenona Alter with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines used to treat AIDS), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression), as these medicines reduce the metabolism of Eplerenona Alter, and thus prolong its effect in the body.
• Potassium-sparing diuretics (medicines that help your body get rid of excess fluid) or potassium supplements (salt tablets), as these medicines increase the risk of high levels of potassium in the blood.

• Lithium (used to treat 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.
• Cyclosporin or tacrolimus (used to treat skin diseases such as psoriasis or eczema and to prevent organ transplant rejection). 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.
• ACE inhibitors and angiotensin receptor antagonists (used to treat high blood pressure, heart disease, or certain kidney diseases) at the same time, as these medicines can 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 cause a decrease in blood pressure and dizziness when standing up.
• Tricyclic antidepressants such as amitriptyline or amoxapine (used to treat depression), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (used to treat psychiatric disorders), amifostine (used during cancer chemotherapy), and baclofen (used to treat muscle spasms). These medicines may cause 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 to treat heart diseases). Blood levels of digoxin may increase when taken with eplerenone.
• Warfarin (an anticoagulant medicine): caution is required when administering warfarin doses because high levels of warfarin in the blood may cause changes in eplerenone in 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 problems and high blood pressure) because they reduce the metabolism of eplerenone, thus prolonging its effect in the body.
• Hypericum perforatumor St. John's Wort (a herbal product), 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 Alter with food and drinks

Eplerenona Alter can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 Eplerenona Alter 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 stop treatment or breast-feeding.

Driving and using machines

After taking Eplerenona Alter, you may feel dizzy. If this happens, do not drive or use machines.

Eplerenona Alter contains lactose

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

3. How to take Eplerenona Alter

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

Eplerenona Alter 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 Eplerenona Alter, during the first week, and one month after 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 one 25 mg tablet per day. And if you have moderate kidney problems, you should start treatment with one 25 mg tablet every other day. These doses may be adjusted, if your doctor indicates, and according to your potassium blood levels. Eplerenona Alter 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, it may be necessary to perform potassium blood level determinations more frequently (see also "Do not take Eplerenona Alter").

In elderly patients:No initial dose adjustment is required.

In children and adolescents:Eplerenona Alter is not recommended.

If you take more Eplerenona Alter than you should

If you take more Eplerenona Alter than you should, tell 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 Alter

If it is almost time for your next dose, skip the missed dose and take the next dose at the right time.

Otherwise, take the dose as soon as you remember, provided that more than 12 hours have passed since the time you should have taken the dose. Go back to taking your medicine as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Eplerenona Alter

It is important to keep taking Eplerenona Alter as your doctor has told you, unless your doctor tells you to stop.

If you have any further questions on the use of this product, 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 side effects reported 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)
• fainting
• dizziness
• 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 can cause dizziness when standing up
• blood clots in the legs
• sore throat
• flatulence
• underactive thyroid
• increased blood sugar levels
• 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 they are not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use, Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Eplerenona Alter

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after the abbreviation EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenona Alter

• The active substance of this medicine is eplerenone. Each tablet contains 25 mg of eplerenone.

The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, talc, magnesium stearate.

Coating of the tablet: Hypromellose, Macrogol 400, Polysorbate 80 (E433), Titanium dioxide, Yellow iron oxide (E172), and Red iron oxide (E172).

Appearance of Eplerenona Alter and contents of the pack

Eplerenona Alter 25 mg film-coated tablets are beige, round, and biconvex with the inscription "25" on one side.

Eplerenona Alter 25 mg film-coated tablets are available in cartons with blisters containing 10, 20, 28, 30, 50, 90, 100, or 200 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

Date of last revision of this leaflet: February 2019

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