Leaflet:information for the user

EplerenonAristo 25 mgfilm-coated tablets

Eplerenona Aristo 50 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine because 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 medicine has been prescribed for you only, and you must not give it to otherseven if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.Seesection4.

1.What isEplerenonAristoand what it is used for

2.What you need to know before starting to takeEplerenonAristo

3.How to takeEplerenonAristo

4.Possible side effects

5.Storage ofEplerenonAristo

6.Contents of the pack and additional information

EplerenoneAAristo 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. Elevated levels of aldosterone can produce changes in the body that lead to heart failure.

EplerenoneAAristo 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. persistent mild symptoms, despite the treatment you have been receiving up to now.

Do not take Eplerenonto Aristo

• 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 fluids (potassium-sparing diuretics) or "salt tablets" (potassium supplements),
• if you have severe kidney disease,
• if you have severe liver disease,
• 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 or high blood pressure conditions (such as angiotensin-converting enzyme inhibitors (ACE) and angiotensin receptor antagonists (ARA)) at the same time.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Eplerenon to Aristo:

• if you have kidney or liver disease (also see "Do not take Eplerenon to Aristo"),
• if you are taking lithium (usually used to treat manic-depressive disorders, also known as bipolar disorder),
• if you are taking tacrolimus or cyclosporine (used to treat skin conditions such as psoriasis or eczema and to prevent organ transplant rejection).

Pediatric population

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

Use of Eplerenon to Aristo with other medicines

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

You should not take Eplerenon to Aristo with the following medicines (see section "Do not use Eplerenon to Aristo"):

• ketoconazole or itraconazole (used to treat fungal infections), ritonavir, nelfinavir (used to treat HIV infections), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression), as these medicines reduce the metabolism of Eplerenon to Aristo, and therefore prolong its effect in the body.
• Diuretics called potassium-sparing diuretics (medicines that help your body get rid of excess fluids) 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 (used to treat high blood pressure, heart disease or certain kidney diseases) at the same time, as these medicines may increase the risk of high levels of potassium in the blood.

Inform your doctor if you are taking any of the following medicines:

• Lithium (usually used to treat manic-depressive disorders, also known as bipolar disorder). The use of lithium with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) has been shown to cause high levels of lithium in the blood that may cause the following adverse reactions: loss of appetite, vision disturbances, fatigue, muscle weakness and muscle cramps.
• Cyclosporine or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent organ transplant rejection). These medicines may cause kidney problems and therefore increase the risk of high levels of potassium in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - certain analgesics such as ibuprofen (used to relieve pain, stiffness and inflammation). These medicines may cause kidney problems and therefore 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 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.
• Glucocorticoids such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions) and tetracosactide (used mainly to diagnose and treat adrenal gland disorders) may reduce the blood pressure-lowering effect of Eplerenon to Aristo.
• Digoxin (used to treat heart conditions). The levels of digoxin in the blood may increase when taken with Eplerenon to Aristo.
• Warfarin (an anticoagulant): Caution is required when administering warfarin doses because high levels of warfarin in the blood may cause changes in the effect of Eplerenon to Aristo in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral used to treat HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem and verapamil (used to treat heart conditions and high blood pressure) may reduce the metabolism of Eplerenon to Aristo, prolonging its effect in the body.
• St. John's Wort (Hypericum perforatum), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used to treat epilepsy) may increase the metabolism of Eplerenon to Aristo and therefore reduce its effect.

Taking Eplerenon to Aristo with food and drinks

Eplerenon to Aristo can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.Eplerenon to Aristo has not been evaluated in humans during pregnancy.

The safety of eplerenone during breastfeeding is unknown. Your doctor will decide with you whether to stop treatment or breastfeeding.

Driving and operating machinery

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

Eplerenon to Aristo contains lactose monohydrate

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

Eplerenona Aristo contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

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

Eplerenon Aristo is usually administered together with other medications for heart failure, for example, beta-blockers. The usual initial dose is one 25 mg tablet once a day, increasing after 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 determinations should be performed before starting treatment with Eplerenon Aristo, during the first week, and one month after starting treatment or after a change in dose. Your doctor may adjust the dose based on your blood potassium levels.

Patients with liver or kidney problems

If you have mild renal insufficiency, you should start treatment with one 25 mg tablet per day, and if you have moderate renal insufficiency, you should start treatment with one 25 mg tablet every other day. These doses may be adjusted, if your doctor indicates, and in accordance with your blood potassium levels.

Eplerenon Aristo is not recommended for patients with severe renal disease.

No initial dose adjustment is necessary for patients with mild to moderate liver insufficiency. If you have any liver or kidney disease, you may need to have your blood potassium levels checked more frequently (see also “Do not take Eplerenon Aristo”).

Patients of advanced age

In patients of advanced age: no initial dose adjustment is required.

Use in children and adolescents

In children and adolescents: Eplerenon Aristo is not recommended.

If you take more Eplerenon Aristo than you should

If you take more Eplerenon 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, 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Eplerenon Aristo

If it is almost time to take the next tablet, skip the dose you forgot and take the next tablet at the usual time.

Otherwise, take the tablet as soon as you remember, provided it has been more than 12 hours since the time you usually take the next tablet. Resume your medication as usual.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eplerenon Aristo

It is essential to continue taking Eplerenon Aristo as instructed, 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.

Like all medications, this medication can produce adverse effects, although not all people will experience them.

If any of the following occur:

Seek immediate medical attention

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

These are symptoms of angioneurotic edema, a rare adverse effect (affecting up to 1 in 100 people).

Other reported adverse effects include:

Frequent adverse 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),
• syncope
• dizziness,
• high levels of cholesterol in the blood
• insomnia (difficulty sleeping)
• headache
• cardiac discomfort, for example, irregular heartbeats and heart failure
• cough,
• constipation,
• low blood pressure,
• diarrhea,
• nausea,
• vomiting,
• abnormal kidney function,
• eruption,
• itching,
• back pain,
• weakness
• muscle spasms
• increased levels of urea in the blood
• increased levels of creatinine in the blood that may indicate kidney problems

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use, webpage:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

This medication does not require special storage conditions.

Do not usethis medicationafter the expiration date that appears onthe packaging and outer carton after CAD.The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of the containers and medicationsthat you no longer need at the SIGREpoint at the pharmacy. Ask your pharmacisthow to dispose ofthecontainers and medications that you no longerneed.By doing so, you will help protect the environment.

Eplerenone CompositionaAristo

The active ingredient of the film-coated tablets of Eplerenona Aristo 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 opadry yellow 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).

Appearance of the product and contents of the package

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

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

EplerenonaAristo 25 mg and 50 mg film-coated tablets are presented in blisters of PVC opaque-Aluminium containing 10, 20, 28, 30, 50, 90, 100, or 200 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

Responsible 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 with 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

Last date of revision of this leaflet:July2022

The detailed and updated information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es