Eplerenone Teva 25 mg film-coated tablets EFG

Patient Leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Eplerenone Teva 25 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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, since 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 Teva is and what it is used for

2. What you need to know before taking Eplerenone Teva

3. How to take Eplerenone Teva

4. Possible adverse effects

5. How to store Eplerenone Teva

6. Contents of the pack and other information

1. What Eplerenona Teva is and what it is 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 that controls blood pressure and heart function. Elevated 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 recently had a 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 starting to take Eplerenone Teva

Do not take Eplerenone 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 (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 (nelfinavir or ritonavir)
• if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin)
• if you are taking nefazodone for depression
• if you are taking at the same time medicines used to treat certain heart conditions or high blood pressure (such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs)).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take eplerenone:

• if you have kidney or liver disease (see also “Do not take Eplerenone Teva”)
• if you are taking lithium (commonly used for manic depression, 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 has not been established.

Taking Eplerenone Teva with other medicines

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 HIV), 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 eliminate excess fluid from the body) or potassium supplements (salt tablets), as these medicines increase the risk of high potassium levels in the blood.

• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) 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 depression, 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 thereby 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 thereby 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 conditions) and tetracosactide (used mainly 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 (an antiviral medicine for the treatment of HIV), 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, 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 thereby reduce its effect.

Taking Eplerenone Teva with food and drink

Eplerenone Teva may 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 any 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 breastfeeding or discontinue treatment.

Driving and using machines

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

Lactose

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

Sodium

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

3. How to take Eplerenone Teva

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. Consult your doctor or pharmacist if you have any doubts.

Eplerenone Teva film-coated tablets may be taken with or without food. Swallow the tablets whole with plenty of water.

Eplerenone Teva is usually administered together with other medications for heart failure, for example, beta-blockers. The recommended 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 per day.

Blood potassium levels should be measured before starting treatment with eplerenone, 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, as directed by your doctor, according to your blood potassium levels.

Eplerenone 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 liver or kidney problems, you may require more frequent blood potassium monitoring (see also "Do not take Eplerenone Teva").

In elderly patients, no initial dose adjustment is required.

Use in children and adolescents

Eplerenone Teva is not recommended in children and adolescents.

If you take more Eplerenone Teva than you should

If you take more Eplerenone Teva than you should, contact your doctor or pharmacist immediately. If you have taken an excessive amount of the 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 or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Eplerenone Teva

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 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 Eplerenone Teva

It is important to continue taking Eplerenone Teva as directed, unless your doctor tells 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 can cause adverse effects, although not everyone will experience them.

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

Other reported adverse effects include:

Frequent (may affect up to 1 in 10 people):

• elevated blood potassium levels (these symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache)
• dizziness
• fainting
• elevated blood cholesterol levels
• insomnia (difficulty sleeping)
• headache
• heart problems, 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 (may affect up to 1 in 100 people):

• infection
• eosinophilia (increase in certain white blood cells)
• dehydration
• elevated levels of triglycerides (fats) in blood
• low blood sodium levels
• 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 adverse effects, consult your doctor, pharmacist or nurse, even if these adverse effects are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone 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 stated on the packaging and blister after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone Teva

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

• The other ingredients are monohydrate lactose, 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).

Description of the product and contents of the container

Film-coated tablet.

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

Eplerenone Teva 25 mg film-coated tablets EFG is available in opaque PVC/PVdC/Al blisters containing 1, 10, 20, 28, 30, 50, 90, 100 and 200 tablets, and in pre-cut single-dose opaque PVC/PVdC/Al blisters containing 20 x 1, 30 x 1, 50 x 1, 90 x 1, 100 x 1 or 200 x 1 tablets. It is also available in calendar blister packs of 30 and 100 tablets.

Only certain 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
The 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 Kraków
Poland

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

Germany: Eplerenon AbZ 25 mg Filmtabletten
Austria: Eplerenon Ratiopharm GmbH 25 mg Filmtabletten
Denmark: Eplerenone Teva 25 mg filmovertrukne tabletter
Spain: Eplerenona Teva 25 mg comprimidos recubiertos con película EFG
Greece: Eplerenone Teva 25 mg Επικαλυμμένα με λεπτό υμένιο δισκία
France: Eplérénone Teva 25 mg comprimé pelliculé
The Netherlands: Eplerenone Teva 25 mg filmomhulde tabletten
Sweden: Eplerenone Teva 25 mg filmfragerade tableter
United Kingdom: Eplerenone 25 mg Film-coated tablets
Slovak Republic: Eplerenone Teva 25 mg

Date of the most recent revision of this leaflet: April 2021

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/