EPLERENONE TEVA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Eplerenona Teva 25 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 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 is Eplerenona Teva and what is it used for
2. What you need to know before you take Eplerenona Teva
3. How to take Eplerenona Teva
4. Possible side effects
5. Storage of Eplerenona Teva

1. Contents of the pack and further information

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

Eplerenona Teva 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, which controls blood pressure and cardiac function. High levels of aldosterone can cause changes in your body that lead to heart failure.

Eplerenona Teva is used to treat heart failure to prevent worsening and reduce hospitalization if:

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

2. What you need to know before you take Eplerenona Teva

Do not takeEplerenona Teva

• 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 from groups that help eliminate excess fluid in the body (potassium-sparing diuretics)
• 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 antiviral medicines used to treat HIV (nelfinavir or ritonavir)
• 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 angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs)).

Warnings and precautions

Consult your doctor or pharmacist before starting to take eplerenone:

• if you have kidney or liver disease (see also “Do not take Eplerenona Teva”)
• if you are taking lithium (usually used for manic-depressive disorder, also called bipolar disorder)
• if you are taking tacrolimus or cyclosporine (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.

Taking Eplerenona Teva with other medicines

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 for HIV), 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 eliminate excess fluid in the body) or potassium supplements (salt tablets) as these medicines increase the risk of high levels of potassium in the blood.
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) 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 (usually used for manic-depressive disorder, also called 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 the following adverse reactions: loss of appetite, vision changes, fatigue, muscle weakness, and muscle cramps.
• Cyclosporine 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 drugs (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.
• Corticosteroids, 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 for HIV treatment), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for the treatment of heart problems and high blood pressure) reduce the metabolism of eplerenone, thus prolonging the effect of eplerenone in the body.
• St. John's Wort (a medicinal plant), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy) may increase the metabolism of eplerenone and thus reduce its effect.

Taking Eplerenona Teva with food and drinks

Eplerenona Teva 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 discontinue breastfeeding or stop treatment.

Driving and using machines

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

Lactose

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.

3. How to take Eplerenona Teva

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. Ask your doctor or pharmacist if you have any doubts.

Eplerenona Teva film-coated tablets can be taken with food or on an empty stomach. Swallow the tablets whole with plenty of water.

Eplerenona Teva is usually given together with other medicines for heart failure, for example, beta-blockers. The recommended initial dose is one 25 mg tablet once a day, increasing 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 levels in the blood should be measured before starting treatment with eplerenone, during the first week, and after one month of starting treatment or after a change in dose. Your doctor may adjust the dose based on your potassium levels in the blood.

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

Eplerenone is not recommended in patients with severe kidney disease.

No initial dose adjustment is necessary in patients with mild to moderate hepatic impairment. If you have liver or kidney problems, you may need to have your potassium levels in the blood checked more frequently (see also “Do not take Eplerenona Teva”).

In elderly patients, no initial dose adjustment is necessary.

Use in children and adolescents

In children and adolescents, Eplerenona Teva is not recommended.

If you take more Eplerenona Teva than you should

If you take more Eplerenona Teva than you should, consult your doctor or pharmacist immediately. If you have taken too much medicine, the most likely symptoms will be low blood pressure (manifested as 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).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Eplerenona Teva

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

Otherwise, take the dose as soon as you remember, provided that more than 12 hours have passed since the time you should have taken the dose. Go back to taking your medicine as usual.

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

If you stop taking Eplerenona Teva

It is important to continue takingEplerenona Teva as your doctor has told you, unless your doctor tells you to stop.

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 you experience any of the following, 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 (which may affect up to 1 in 100 people).

Other reported side effects include:

Common(may affect up to1 in 10 people):

• 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 heartbeats and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasms
• increased levels of urea in the blood
• increased levels of creatinine in the blood, which may indicate kidney problems.

Uncommon(may affect up to1 in 100 people):

• 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 may cause dizziness when standing up
• blood clots in the legs
• sore throat
• flatulence
• underactive thyroid
• high blood sugar levels
• decreased sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in certain blood tests.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use, https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenona Teva

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 carton and blister after the abbreviation EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

Composition of Eplerenona Teva

• The active ingredient is eplerenone. Each tablet contains 25 mg of eplerenone.

• The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone (type A), sodium lauryl sulfate, talc (E553b), and magnesium stearate. The coating contains polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and container contents

Coated tablet.

Yellow, diamond-shaped, biconvex, film-coated tablets, approximately 6.4 mm wide and 7.4 mm long, engraved with "E25" on one side and smooth on the other.

Eplerenona Teva 25 mg film-coated tablets EFG are available in opaque PVC/PVdC/Al blisters containing 1, 10, 20, 28, 30, 50, 90, 100, and 200 tablets, and in opaque PVC/PVdC/Al unit dose blisters containing 20 x 1, 30 x 1, 50 x 1, 90 x 1, 100 x 1, or 200 x 1 tablets. They are also available in a calendar blister pack of 30 and 100 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

c/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3, 89143 Blaubeuren

Germany

Or

Teva UK Ltd.

Brampton Road, Hampden Park, Eastbourne

East Sussex, BN22 9AG

United Kingdom

Or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Or

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Or

Teva Czech Industries s.r.o.

Ostravská 29, c.p. 305, 747 70 Opava, Komárov

Czech Republic

Or

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Or

Teva Operations Poland Sp. Z.o.o.

ul. Mogilska 80, 31-546 Cracow

Poland

This medicinal product is authorized in the following European Economic Area Member States with the following names:

Germany: Eplerenon AbZ 25 mg film-coated tablets

Austria: Eplerenon Ratiopharm GmbH 25 mg film-coated tablets

Denmark: Eplerenone Teva 25 mg film-coated tablets

Spain: Eplerenona Teva 25 mg film-coated tablets EFG

Greece: Eplerenone Teva 25 mg film-coated tablets

France: Eplérénone Teva 25 mg film-coated tablets

Netherlands: Eplerenone Teva 25 mg film-coated tablets

Sweden: Eplerenone Teva 25 mg film-coated tablets

United Kingdom: Eplerenone 25 mg film-coated tablets

Slovak Republic: Eplerenone Teva 25 mg

Date of last revision of this leaflet:April2021

Detailed and updated 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/