EPLERENONE SANDOZ 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eplerenone Sandoz 25 mg film-coated tablets EFG

Eplerenone Sandoz 50 mg film-coated tablets EFG

Readall 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 Eplerenone Sandoz is and what it is used for
2. What you need to know before you take Eplerenone Sandoz
3. How to take Eplerenone Sandoz
4. Possible side effects
5. Storage of Eplerenone Sandoz
6. Contents of the pack and other information

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

Eplerenone Sandoz belongs to a group of medicines known as selective aldosterone blockers. These blocking agents 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:

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

2. What you need to know before you take Eplerenone Sandoz

Do not take Eplerenone:

• 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 antiviral 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, pharmacist, or nurse before starting treatment with Eplerenone Sandoz

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

Other medicines and Eplerenone Sandoz

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 eplerenone, and thus prolong its effect in the body,
• potassium-sparing diuretics (medicines that help your body get rid of excess fluid) and 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 (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 cause adverse reactions such as 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 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,
• glucocorticoids, 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 because high levels of warfarin in the blood may alter the effect of 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 (for the treatment of heart problems and high blood pressure) because they reduce the metabolism of eplerenone, thus prolonging its effect in the body,
• St. John's Wort (a herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among other things, to treat epilepsy) may increase the metabolism of eplerenone and thus reduce its effect.

Taking Eplerenone Sandoz with food and drinks

Eplerenone Sandoz 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 stop treatment or breastfeeding.

Driving and using machines

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

Eplerenone Sandoz contains lactose monohydrate and sodium

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

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

3. How to take Eplerenone Sandoz

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

Eplerenone Sandoz is usually given in combination 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 Sandoz, 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. 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.

Eplerenone Sandoz 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 Eplerenone Sandoz").

In elderly patients: no initial dose adjustment is required.

In children and adolescents: Eplerenone Sandoz is not recommended.

If you take more Eplerenone Sandoz than you should

If you take more Eplerenone Sandoz than you should, contact your doctor or pharmacist immediately. If you have taken too much medicine, the most likely symptoms will be low blood pressure (manifested as a feeling of fainting, 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).

If you have taken more Eplerenone Sandoz than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Eplerenone Sandoz

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

Otherwise, take the dose as soon as you remember, provided that more than 12 hours have passed since the scheduled time for the next dose. Resume taking your medicine as usual.

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

If you stop taking Eplerenone Sandoz

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

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 patients):

• 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,
• feeling of 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 patients):

• infection
• eosinophilia (an increase in certain white blood cells),
• dehydration,
• high levels of triglycerides (fats) in the blood,
• low levels of sodium 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 glucose levels,
• decreased sense of touch,
• increased sweating,
• musculoskeletal pain,
• general malaise,
• kidney inflammation,
• breast enlargement in men,
• changes in the results of some blood tests.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Sandoz

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 EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone Sandoz

The active substance is eplerenone.

Each Eplerenone Sandoz 25 mg tablet contains 25 mg of eplerenone.

Each Eplerenone Sandoz 50 mg tablet contains 50 mg of eplerenone.

The other ingredients are:

Core of the tablet:

Lactose monohydrate

Microcrystalline cellulose (type 101)

Croscarmellose sodium

Hypromellose (Type 2910)

Microcrystalline cellulose (type 102)

Sodium lauryl sulfate

Talc

Magnesium stearate

Coating of the tablet:

Lactose monohydrate

Hypromellose (Type 2910)

Titanium dioxide (E171)

Macrogol 4000

Appearance of the product and pack contents

Eplerenone Sandoz 25 mg tablets: are white or almost white, round, approximately 6 mm in diameter, biconvex, marked "CG3" on one side of the tablet and unmarked on the other side.

Eplerenone Sandoz 50 mg tablets: are white or almost white, round, biconvex, approximately 8 mm in diameter, marked "CG4" on one side of the tablet and unmarked on the other side.

The tablets are packaged in PVC/aluminum blisters inside a cardboard box containing 10, 20, 30, 50, 90, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid Spain

Manufacturer

Laboratorios LICONSA S.A.

Avenida Miralcampo 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Genericon Pharma Gesellschaft m.b.H.,

Hafnerstrasse 211

8054 Graz,

Austria

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Eplerenon +pharma 25/50 mg Filmtabletten

Germany: Eplerenon AL 25 mg Filmtabletten

Eplerenon AL 50 mg Filmtabletten

Romania: EPLOHART 25 mg film-coated tablets

EPLOHART 50 mg film-coated tablets

Norway: Eplerenon Medical Valley 25 mg tablets, film-coated

Eplerenon Medical Valley 50 mg tablets, film-coated

Sweden: Eplerenon Medical Valley

Eplerenon Medical Valley

Denmark: Eplerenon Medical Valley

Eplerenon Medical Valley

Date of last revision of this leaflet: December 2021

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