Package Insert: Information for the Patient

Eplerenona Teva 50 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

6. Contents of the pack and additional information

Eplerenona Teva belongs to a group of medications 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. Elevated levels of aldosterone can produce changes in the body that lead to heart failure.

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

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

Do not takeEplerenona Teva

• 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 failure
• if you have severe liver failure
• if you are taking medications used to treat fungal infections (ketoconazole or itraconazole)
• if you are taking antiviral medications 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 to treat depression
• if you are taking medications used to treat certain heart or high blood pressure conditions (such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs)) at the same time.

Warnings and precautions

Consult your doctor or pharmacist before starting to take eplerenona:

• if you have a kidney or liver disease (see also “Do not take Eplerenona Teva”)
• if you are taking lithium (usually used to treat manic-depressive disorder, 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 have not been established in children and adolescents.

Taking Eplerenona Teva with other medications

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

• ketoconazole or itraconazole (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 or potassium supplements (potassium 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 (usually used to treat manic-depressive disorder, also known as bipolar disorder). The use of lithium with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) has been shown to cause high levels of lithium in the blood, which 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 on the body.
• erythromycin (used to treat bacterial infections), saquinavir (antiviral medication for HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart conditions and high blood pressure) reduce the metabolism of eplerenona, prolonging its effect in the body.
• St. John's Wort (herbal remedy), 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 Teva with food and drinks

Eplerenona Teva 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 any medication. Eplerenona has not been evaluated for use during pregnancy in humans.

The elimination of eplerenona in breast milk is unknown. Your doctor will decide with you whether to stop breastfeeding or suspend treatment.

Driving and operating machinery

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

Lactose

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

Sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet, that is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Consult with your doctor or pharmacist if you have doubts.

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

Eplerenona 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 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.

It is necessary to measure blood potassium levels before starting treatment with eplerenona, during the first week, and one month after starting treatment or after a change in dosage. Your doctor will be able to 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, and 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 is not recommended for patients with severe renal disease.

No initial dose adjustment is necessary in patients with mild to moderate liver insufficiency. If you have liver or kidney problems, it may be necessary to make blood potassium determinations more frequently (see also “Do not take Eplerenona Teva”).

No initial dose adjustment is required in elderly patients.

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 medication, the most likely symptoms will be 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Eplerenona Teva

If it is almost time to take the next tablet, skip the dose you forgot and take the next tablet when it is due.

Otherwise, take the tablet as soon as you remember, as long as more than 12 hours have elapsed since the time for the next tablet. Resume taking your medication as usual.

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

If you interrupt treatment with Eplerenona Teva

It is essential to continue takingEplerenona Tevaas 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 medicines,this medicinemay cause side effects, although not everyone will experience 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 angioneurotic edema, a rare side effect (which can affect up to 1 in 100 people).

Other reported side effects include:

Frequent(may affectup to1 in 10 people):

• high levels of potassium in the blood (these 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
• itching
• back pain
• weakness
• muscle spasms
• increase in blood urea levels
• elevation of creatinine levels in the blood that may indicate kidney problems.

Rare(may affectup to1 in 100 people):

• 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
• underactive thyroid
• increase in blood glucose levels
• diminished sense of touch
• increased sweating
• musculoskeletal pain
• general feeling of discomfort
• inflammation of the kidneys
• gynecomastia in men
• changes in certain blood tests.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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 medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and on the blister after the abbreviation CAD. The expiration date is the last day of the month indicated.

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

Eplerenone Teva Composition

• The active ingredient is eplerenone. Each tablet contains 50 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 contents of the package

Coated tablet.

Yellow-coated, diamond-shaped, biconvex tablets, approximately 8.0 mm in width and 9.5 mm in length, engraved with “E50” on one side and smooth on the other.

Eplerenone Teva 50 mg coated tablets EFG are available in PVC/PVdC/Al opaque blisters containing 1, 10, 20, 28, 30, 50, 90, 100, and 200 tablets, and in PVC/PVdC/Al opaque single-dose pre-cut 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 a 100-tablet calendar blister.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Teva Pharma S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Manufacturer responsible

Merckle GmbH

Ludwig-Merckle-Street 3 89143 Blaubeuren

Germany

Or

Teva UK Ltd.

Brampton Road, Hamped 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 Cracovia

Poland

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

Germany:Eplerenon AbZ 50 mg Filmtabletten

Austria:Eplerenon ratiopharm GmbH 50 mg Filmtabletten

Denmark:Eplerenone Teva 50 mg filmovertrukne tabletter

Spain:Eplerenona Teva 50 mg comprimidos recubiertos con película EFG

Greece:Eplerenone Teva 50 mg Επικαλυμ?να με λεπτ? υμ?νιο δισκ?α

France:Eplérénone Teva 50 mg comprimé pelliculé

Netherlands:Eplerenone Teva 50 mg filmomhulde tabletten

Sweden:Eplerenone Teva 50 mg filmdragerade tablette

United Kingdom:Eplerenone 50 mg Film-coated Tablets

Slovak Republic:Eplerenone Teva 50 mg

Last review date of this leaflet: April 2021

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/