Eplerenone Aristo 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eplerenone Aristo 25 mg film-coated tablets EFG

Eplerenone Aristo 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Eplerenone Aristo is and what it is used for
2. What you need to know before taking Eplerenone Aristo
3. How to take Eplerenone Aristo
4. Possible adverse effects
5. How to store Eplerenone Aristo
6. Contents of the pack and other information

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

Eplerenone Aristo 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 can cause changes in the body that may lead to heart failure.

Eplerenone Aristo is used to treat heart failure to prevent its worsening and reduce hospitalization in patients who have:

1. recently suffered a myocardial infarction, in combination with other medications used to treat heart failure, or
2. persistent mild symptoms despite ongoing treatment.

2. What you need to know before taking Eplerenone Aristo

Do not take Eplerenone Aristo

• 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 (hyperkalemia),
• if you are taking medicines from groups that help your body eliminate excess fluid (potassium-sparing diuretics) or "salt tablets" (potassium supplements),
• 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 simultaneously taking medicines used to treat certain heart conditions or hypertension (such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARBs)).

Warnings and precautions

Talk to your doctor or pharmacist before taking Eplerenone Aristo:

• if you have kidney or liver disease (see also “Do not take Eplerenone Aristo”),
• 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 conditions such as psoriasis or eczema and to prevent rejection of transplanted organs).

Paediatric population

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

Use of Eplerenone Aristo with other medicines

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

You must not take Eplerenone Aristo with the following medicines (see section “Do not use Eplerenone Aristo”):

• 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 Aristo, thereby prolonging its effect in the body.
• Potassium-sparing diuretics (medicines that help your body eliminate excess fluid) or potassium supplements (salt tablets), as these medicines increase the risk of developing high potassium levels in the blood.
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARBs) taken together (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medicines may increase the risk of developing high potassium levels in the blood.

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

• Lithium (commonly used for manic-depressive disorders, also known as 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 lithium levels 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 conditions such as psoriasis or eczema and to prevent rejection of transplanted organs). These medicines may cause kidney problems and thus increase the risk of developing 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 (used mainly to diagnose and treat adrenal cortex disorders), may reduce the blood pressure-lowering effect of Eplerenone Aristo.
• Digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with Eplerenone Aristo.
• Warfarin (an anticoagulant medicine): Caution is required when administering warfarin, as high warfarin levels in the blood may alter the effect of Eplerenone Aristo in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (antiviral medicine for treating HIV infection), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for treatment of heart problems and high blood pressure) may reduce the metabolism of Eplerenone Aristo, thereby prolonging its effect in the body.
• Hypericum perforatum (St. John's wort) (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy) may increase the metabolism of Eplerenone Aristo and thus reduce its effect.

Taking Eplerenone Aristo with food and drink

Eplerenone Aristo 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 Aristo during pregnancy has not been evaluated in humans.

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

Driving and use of machines

You may feel dizzy after taking Eplerenone Aristo. If this occurs, do not drive or operate machinery.

Eplerenone Aristo contains lactose monohydrate

Eplerenone Aristo contains lactose monohydrate (a type of sugar). If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Eplerenone Aristo contains sodium

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

3. How to take Eplerenona Aristo

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

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

Eplerenona Aristo 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 dosing regimen is 50 mg per day.

Blood potassium levels should be measured before starting treatment with Eplerenona Aristo, 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.

Patients with liver or kidney problems

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.

Eplerenona Aristo 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 Aristo").

Elderly patients

In elderly patients: no initial dose adjustment is required.

Use in children and adolescents

In children and adolescents: Eplerenona Aristo is not recommended.

If you take more Eplerenona Aristo than you should

If you take more Eplerenona Aristo than you should, inform your doctor or pharmacist immediately. If you have taken too much medicine, 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, pharmacist, or the Toxicology Information Service immediately, phone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eplerenona Aristo

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 tablet as soon as you remember, provided that more than 12 hours remain before your next scheduled dose. Then continue taking your medicine as usual.

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

If you stop taking Eplerenona Aristo

It is important to continue taking Eplerenona Aristo as directed, unless your doctor advises you to stop treatment.

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 may cause adverse effects, although not everyone experiences 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 angioedema, an uncommon 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):

• elevated blood potassium levels (these symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache),
• fainting,
• dizziness,
• high blood cholesterol levels,
• insomnia (difficulty sleeping),
• headache,
• heart discomfort, for example, irregular heartbeat and heart failure,
• cough,
• constipation,
• low blood pressure,
• diarrhoea,
• 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,
• reduced sense of touch,
• increased sweating,
• musculoskeletal pain,
• general malaise,
• kidney inflammation,
• breast enlargement 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, website: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Aristo

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 which is stated on the packaging and outer carton, following EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone Aristo

The active substance in Eplerenone Aristo film-coated tablets is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.

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

The yellow opadry coating of Eplerenone 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).

Nature of the medicinal product and contents of the pack

Eplerenone Aristo 25 mg tablet is a yellow, biconvex, round, film-coated tablet, marked with "E25" on one side.

Eplerenone Aristo 50 mg tablet is a yellow, biconvex, round, film-coated tablet, marked with "E50" on one side.

Eplerenone Aristo 25 mg and 50 mg film-coated tablets are available in cartons with white opaque PVC-aluminum blisters containing 10, 20, 28, 30, 50, 90, 100 or 200 film-coated tablets.

Only certain pack 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 European Economic Area member states under the following names:

Denmark 25mg: Eplerenon Pharmathen

50mg: Eplerenon Pharmathen

Iceland 25mg: Eplerenone Algoven

50mg: Eplerenone Algoven

Austria 25mg: Eplezot 25mg Filmtabletten

50mg: Eplezot 50mg Filmtabletten

Poland 25mg: Eplenocard

50mg: Eplenocard

Greece 25mg: Vaner

50mg: Vaner

Spain 25mg: EplerenonaAristo film-coated tablets EFG

50mg: EplerenonaAristo film-coated tablets EFG

Date of the most recent revision of this leaflet: July 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