Leaflet: information for the user

Eplerenona Sandoz 25 mg film-coated tablets

Eplerenona Sandoz 50 mg film-coated tablets

Readthe entire 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even 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. See section 4.

1. What isEplerenona Sandozand what it is used for

2. What you need to know before you start takingEplerenona Sandoz

3. How to takeEplerenona Sandoz

4. Possible side effects

5. Storage ofEplerenona Sandoz

6. Contents of the pack and additional information

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

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

Do not take Eplerenona:

• If you are allergic to eplerenona 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 your body get rid of excess fluids (potassium-sparing diuretics),
• If you have severe kidney disease,
• If you have severe liver disease,
• If you are taking medications used to treat fungal infections (ketoconazole or itraconazole),
• If you are taking antiviral medications 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 medications used to treat certain heart or high blood pressure conditions (such as ACE inhibitors and ARBs) at the same time.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Eplerenona Sandoz

• If you have kidney or liver disease (see “Do not take Eplerenona Sandoz”),
• 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).

Children and adolescents

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

Other medications and Eplerenona Sandoz

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

• 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 eplerenona, and therefore prolong its effect in the body,
• Potassium-sparing diuretics and potassium supplements (salt tablets), as these medications increase the risk of high potassium levels in the blood,
• ACE inhibitors and ARBs at the same time (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medications may increase the risk of high potassium levels 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 that may cause the following adverse reactions: loss of appetite, vision changes, 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 medications may cause kidney problems and therefore increase the risk of high potassium levels in the blood,
• Nonsteroidal anti-inflammatory drugs (NSAIDs – certain pain relievers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medications may cause kidney problems and therefore 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 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 medications 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 primarily to diagnose and treat adrenal gland disorders) may reduce the blood pressure-lowering effect of eplerenona,
• Digoxin (used to treat heart conditions). The levels of digoxin in the blood may increase when taken with eplerenona,
• Warfarin (an anticoagulant medication): Caution is required when administering warfarin doses because high levels of warfarin in the blood may cause changes in the effect of eplerenona 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 (used to treat heart conditions and high blood pressure) may reduce the metabolism of eplerenona, prolonging its effect in the body,
• St. John's Wort (a medicinal plant), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy) may increase the metabolism of eplerenona and therefore reduce its effect.

Taking Eplerenona Sandoz with food and drinks

Eplerenona Sandoz 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 medication. Eplerenona has not been evaluated in humans during pregnancy.

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

Driving and operating machinery

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

Eplerenona Sandoz contains lactose monohydrate and sodium

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

This medication contains less than 23 mg of sodium (1 mmol) per coated 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.

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

Eplerenona Sandoz 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 Eplerenona Sandoz, 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.

If you have mild renal insufficiency, you should start treatment with one 25 mg tablet per day. 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.

Eplerenona Sandoz 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 Eplerenona Sandoz”).

In elderly patients: no initial dose adjustment is required.

In children and adolescents: Eplerenona Sandoz is not recommended.

If you take more Eplerenona Sandoz than you should

If you take more Eplerenona Sandoz 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 a feeling of fainting, 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).

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

If you forget to take Eplerenona Sandoz

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, as long as more than 12 hours have elapsed since the usual time for taking the next tablet. Resume your usual medication schedule.

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

If you interrupt treatment with Eplerenona Sandoz

It is essential to continue taking Eplerenona Sandoz 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 medicationcan 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 angioneurotic edema,a rare side effect (affecting up to 1 in 100 people).

Other reported side effects include:

Frequent side effects(may affect up to 1 in 10 patients):

• high levels of potassium in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache),
• dizziness,
• syncope,
• 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,
• pruritus,
• back pain,
• sensation of weakness,
• muscle spasms,
• increase in blood urea levels.
• increase in creatinine levels in the blood that may indicate kidney problems.

Rare side effects(may affect up to 1 in 100 patients):

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not usethis medicationafter the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGREpointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Eplerenona Sandoz

The active ingredient is eplerenone.

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

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

The other excipients are:

Tablet core:

Lactose monohydrate

Microcrystalline cellulose (type 101)

Sodium croscarmellose

Hydroxypropyl methylcellulose (Type 2910)

Microcrystalline cellulose (type 102)

Sodium lauryl sulfate

Talc

Magnesium stearate

Tablet coating::

Lactose monohydrate

Hydroxypropyl methylcellulose (Type 2910)

Titanium dioxide (E171)

Macrogol 4000

Appearance of the product and contents of the package

Eplerenona Sandoz 25 mg tablets: are white or almost white, round, biconvex, approximately 6 mm in diameter, marked “CG3” on one face of the tablet and not marked on the other face.

Eplerenona Sandoz 50 mg tablets: are white or almost white, round, biconvex, approximately 8 mm in diameter, marked “CG4” on one face of the tablet and not marked on the other face.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid Spain

Manufacturer responsible

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 medicinal product 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 comprimate filmate

EPLOHART 50 mg comprimate filmate

Norway:Eplerenon Medical Valley 25 mg Tablett, filmdrasjert

Eplerenon Medical Valley 50 mg Tablett, filmdrasjert

Sweden:Eplerenon Medical Valley

Eplerenon Medical Valley

Denmark:Eplerenon Medical Valley

Eplerenon Medical Valley

Last review date of this leaflet: December 2021

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