Eplerenone Sandoz 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eplerenone Sandoz 25 mg film-coated tablets EFG

Eplerenone Sandoz 50 mg film-coated tablets EFG

Read the entire 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Eplerenona 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 regulates blood pressure and heart function. Elevated levels of aldosterone may cause changes in the body that lead to heart failure.

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

• recently had a myocardial infarction, in combination with other medicines used to treat heart failure, or
• persistent mild symptoms despite ongoing treatment.

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

Do not take Eplerenone Sandoz:

• 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 (hyperkalaemia),
• if you are taking medicines from groups that help your body eliminate excess fluid (potassium-sparing diuretics),
• if you have severe renal impairment,
• if you have severe hepatic impairment,
• if you are taking antifungal 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 for depression,
• if you are simultaneously taking medicines used to treat certain heart conditions or hypertension (such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists (ARA)).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Eplerenone Sandoz

• if you have kidney or liver disease (see “Do not take Eplerenone Sandoz”),
• if you are taking lithium (commonly used for 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 rejection of transplanted organs).

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 need to take any other medicines.

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for treating AIDS), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the metabolism of eplerenone, thereby prolonging its effect in the body,
• potassium-sparing diuretics (medicines that help your body eliminate excess fluid) and potassium supplements (salt tablets), as these medicines increase the risk of developing high potassium levels in the blood,
• angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists (ARA) taken together (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medicines may increase the risk of high potassium levels in the blood,
• 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 levels of lithium in the blood, which may lead to adverse reactions such as 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 therefore increase the risk of 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 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 conditions), may lead to a drop in blood pressure and dizziness upon standing,
• tricyclic antidepressants such as amitriptiline or amoxapine (for the treatment of depression), antipsychotics (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 drop in blood pressure and dizziness upon standing,
• glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions) and tetracosactide (mainly used to diagnose and treat adrenal cortex disorders), may reduce the blood pressure-lowering effect of eplerenone,
• digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with eplerenone,
• warfarin (an anticoagulant medicine): Caution is required when administering warfarin doses, as high levels of warfarin in the blood may cause changes in the effect of eplerenone in the body,
• erythromycin (used to treat bacterial infections), saquinavir (antiviral medicine for treating HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for the treatment of heart problems and high blood pressure) may reduce the metabolism of eplerenone, thereby prolonging its effect in the body,
• 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 and therefore reduce its effect.

Taking Eplerenone Sandoz with food and drink

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 become pregnant, consult your doctor or pharmacist before using this medicine. The effect of eplerenone 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 using machines

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

Eplerenone Sandoz contains lactose monohydrate and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Eplerenona Sandoz

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

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 medicines for heart failure, for example, beta-blockers. The usual initial 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 dosage regimen is 50 mg once daily.

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

If you have mild renal impairment, you should start treatment with one 25 mg tablet daily. If you have moderate renal impairment, you should start treatment with one 25 mg tablet every other day. These doses may be adjusted, if your doctor advises, according to your blood potassium levels.

Eplerenona Sandoz is not recommended in patients with severe renal impairment.

No initial dose adjustment is required 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 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 an overdose, the most likely symptoms are low blood pressure (manifested as a feeling of faintness, dizziness, blurred vision, weakness, or acute loss of consciousness) or hyperkalaemia, high levels of potassium in the blood (manifested by muscle cramps, diarrhoea, nausea, dizziness, or headache).

If you have taken more Eplerenona Sandoz than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Eplerenona Sandoz

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 the time of the next 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 Sandoz

It is important to continue taking Eplerenona Sandoz as directed, unless your doctor tells you otherwise.

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 can cause adverse effects, although not everyone 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 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 patients):

• elevated blood potassium levels (these symptoms include muscle cramps, diarrhea, nausea, dizziness or headache),
• dizziness,
• fainting,
• elevated cholesterol levels in blood,
• insomnia (difficulty sleeping),
• headache,
• heart-related discomfort, for example, irregular heartbeats 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 blood,
• elevated levels of creatinine in blood, which may indicate kidney problems.

Uncommon adverse effects (may affect up to 1 in 100 patients):

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

Reporting of adverse effects

If you experience any 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 Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging and blister after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. 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:

Tablet core:

Monohydrate lactose
Microcrystalline cellulose (type 101)
Sodium croscarmellose
Hypromellose (Type 2910)
Microcrystalline cellulose (type 102)
Sodium lauryl sulfate
Talc
Magnesium stearate

Tablet coating:

Monohydrate lactose
Hypromellose (Type 2910)
Titanium dioxide (E171)
Macrogol 4000

Appearance of the product and contents of the pack

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

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

The tablets are packed in bottles within a cardboard box containing 105, 110, 112 and 120 tablets.

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
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
(Only in AT)

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

Austria: Eplerenon +pharma 25/50 mg Film Tablets
Germany: Eplerenon AL 25 mg Film Tablets
Eplerenon AL 50 mg Film Tablets
Romania: EPLOHART 25 mg film-coated tablets
EPLOHART 50 mg film-coated tablets
Norway: Eplerenon Medical Valley 25 mg Tablet, film-coated
Eplerenon Medical Valley 50 mg Tablet, film-coated
Sweden: Eplerenon Medical Valley
Eplerenon Medical Valley
Denmark: Eplerenon Medical Valley
Eplerenon Medical Valley

Date of the most recent review of this leaflet: December 2023

Detailed and up-to-date 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/