EPLERENONE ARISTO 25 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the user

EplerenoneaAristo 25 mgfilm-coated tablets EFG

Eplerenone Aristo 50 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Eplerenone Aristo and what is it used for
2. What you need to know before taking Eplerenone Aristo
3. How to take Eplerenone Aristo
4. Possible side effects
5. Storage of Eplerenone Aristo
6. Package contents and additional information

1. What is Eplerenone Aristo and what is it used for

Eplerenone Aristo belongs to a group of medications 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.

Eplerenone Aristo 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
2. mild persistent symptoms, despite the treatment you have been receiving so far.

2. What you need to know before taking Eplerenone Aristo

Do not take EplerenoneaAristo

• if you are allergic to eplerenone or any of the other components of this medication (listed in section 6)
• if you have high levels of potassium in your blood (hyperkalemia)
• if you are taking medications that help eliminate excess fluid in the body (potassium-sparing diuretics) or "salt tablets" (potassium supplements)
• if you have severe kidney failure
• if you have severe liver failure
• if you are taking medications used to treat fungal infections (ketoconazole or itraconazole)
• if you are taking medications used to treat HIV (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 Eplerenone Aristo:

• if you have kidney or liver disease (see also "Do not take Eplerenone Aristo")
• if you are taking lithium (used to treat manic-depressive disorders, also known as 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)

Pediatric population

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

Use of EplerenoneaAristo withother medications

Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medication.

Do not take Eplerenone Aristo with the following medications (see section "Do not use Eplerenone Aristo"):

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medications for HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medications reduce the metabolism of Eplerenone Aristo and thus prolong its effect in the body.
• Potassium-sparing diuretics (medications that help eliminate excess fluid in the body) or potassium supplements (salt tablets), as these medications 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 medications may increase the risk of high levels of potassium in the blood.

Tell your doctor if you are taking any of the following medications:

• Lithium (used to treat manic-depressive disorders, also known as 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 lead to adverse reactions such as 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 medications can cause kidney problems and thus increase the risk of high levels of potassium in the blood.
• Non-steroidal anti-inflammatory medications (NSAIDs - certain pain relievers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medications 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 medications 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 (used primarily to diagnose and treat adrenal cortex diseases), may reduce the blood pressure-lowering effect of Eplerenone Aristo.
• Digoxin (used to treat heart diseases). Blood levels of digoxin may increase when taken with Eplerenone Aristo.
• Warfarin (an anticoagulant medication): caution is required when administering warfarin doses, as high levels of warfarin in the blood may alter the effect of Eplerenone Aristo in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medication for HIV), 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 Aristo, 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 other things, to treat epilepsy), may increase the metabolism of Eplerenone Aristo and thus reduce its effect.

Taking EplerenoneaAristo with food and drinks

Eplerenone Aristo can 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 medication. The effect of Eplerenone Aristo during pregnancy in humans has not been evaluated.

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

Driving and using machines

After taking Eplerenone Aristo, you may feel dizzy. If this happens, do not drive or operate machinery.

EplerenoneaAristo contains lactose monohydrate

Eplerenone Aristo contains lactose monohydrate (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Eplerenone Aristo contains sodium

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

3. How to take Eplerenone Aristo

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Eplerenone Aristo is usually administered along with other medications for heart failure, such as 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 levels in the blood should be determined before starting treatment with Eplerenone Aristo, 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 levels in the blood.

Patients with liver or kidney problems

If you have mild kidney failure, you should start treatment with one 25 mg tablet per day, and if you have moderate kidney failure, 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 blood potassium levels.

Eplerenone Aristo is not recommended in patients with severe kidney disease.

No initial dose adjustment is necessary in patients with mild to moderate liver failure. If you have any liver or kidney disease, it may be necessary to perform more frequent blood potassium level determinations (see also "Do not take Eplerenone Aristo").

Elderly patients

In elderly patients: no initial dose adjustment is required.

Use in children and adolescents

In children and adolescents: Eplerenone Aristo is not recommended.

If you take more EplerenoneaAristo than you should

If you take more Eplerenone Aristo than you should, inform your doctor or pharmacist immediately. If you have taken too much medication, 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 medication and the amount ingested.

If you forget to take EplerenoneaAristo

If it is almost time to take the next tablet, skip the missed dose and take the next tablet at the corresponding time.

Otherwise, take the tablet as soon as you remember, provided that there are more than 12 hours until the time of taking the next tablet. Resume taking your medication as usual.

Do not take a double dose to make up for missed doses.

If you stop taking EplerenoneaAristo

It is important to continue taking Eplerenone Aristo as indicated by your doctor, unless your doctor tells you to stop treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If any of the following occur:

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 (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
• decrease in blood pressure that may cause dizziness when standing up
• blood clots in the legs
• throat pain
• flatulence
• underactive thyroid
• increased blood glucose levels
• decreased sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in certain blood tests.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through 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 medication.

5. Storage of Eplerenone Aristo

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging and outer carton after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of EplerenonaAristo

The active ingredient of the film-coated Eplerenona Aristo tablets is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.

Eplerenona Aristo 25 mg and 50 mg film-coated tablets EFG also contain the following components: Lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (Typo A), hypromellose (Benecel E3), talc, and magnesium stearate.

The yellow opadry coating of Eplerenona Aristo 25 mg and 50 mg film-coated tablets contains macrogol/PEG 6000, HPMC 2910/ hypromellose 5cP, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Product Appearance and Container Content

The Eplerenona Aristo 25 mg tablet is a film-coated, biconvex, round, yellow tablet, with “E25” engraved on one side.

The Eplerenona Aristo 50 mg tablet is a film-coated, biconvex, round, yellow tablet, with “E50” engraved on one side.

Eplerenona Aristo 25 mg and 50 mg film-coated tablets are presented in boxes with white PVC opaque-Aluminum blisters containing 10, 20, 28, 30, 50, 90, 100, or 200 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

Manufacturer

Pharmathen S.A.

6, Dervenakion str.

15351 Pallini, Attiki

Greece

Pharmathen International SA

Sapes Industrial Park Block 5

69300 Rodopi

Greece

G.L. Pharma GmbH

Schlossplatz 1, 8502 Lannach

Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark25mg: Eplerenon Pharmathen

50mg: Eplerenon Pharmathen

Iceland25mg: Eplerenone Algoven

50mg: Eplerenone Algoven

Austria25mg: Eplezot 25mg Filmtabletten

50mg: Eplezot 50mg Filmtabletten

Poland25mg: Eplenocard

50mg: Eplenocard

Greece25mg: Vaner

50mg: Vaner

Spain25mg: EplerenonaAristofilm-coated tablets EFG

50mg: EplerenonaAristofilm-coated tablets EFG

Date of the last revision of this leaflet:July2022

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