Prospecto:InformationforthePatient

Eplerenona Teva-ratio 25 mg Film-Coated Tablets

Read this 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, ask 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.

6. Contents of the pack and additional information

Eplerenona Teva-ratio 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 may produce changes in the body that lead to heart failure.

Eplerenona 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 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-ratio

• if you are allergic to eplerenona or any of the other ingredients in 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 (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 kidney or liver disease (also see “Do not take Eplerenona Teva-ratio”)
• if you are taking lithium (usually used to treat manic-depressive disorder, also known as bipolar disorder)
• if you are taking tacrolimus or ciclosporina (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.

Taking Eplerenona Teva-ratio 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, prolonging 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.
• tacrolimus or ciclosporina (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 due to the risk of high levels of warfarin in the blood, which may cause changes in the effect of eplerenona in 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-ratio with food and drinks

Eplerenona Teva-ratio 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 safety of eplerenona during breastfeeding is unknown. Your doctor will decide with you whether to stop breastfeeding or suspend treatment.

Driving and operating machinery

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

Lactose

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

Sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet, making it 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-ratio tablets can be taken with food or on an empty stomach. Swallow the tablets whole with plenty of water.

Eplerenona Teva-ratio 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 dose. 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 have your blood potassium levels checked more frequently (see also “Do not take Eplerenona Teva-ratio”).

No initial dose adjustment is required in elderly patients.

Use in children and adolescents

In children and adolescents, Eplerenona Teva-ratio is not recommended.

If you take more Eplerenona Teva-ratio than you should

If you take more Eplerenona Teva-ratio 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 forget to take Eplerenona Teva-ratio

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-ratio

It is essential to continue takingEplerenona Teva-ratioas indicated by your doctor, unless your doctor tells you to stop treatment.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications,this medication may 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 may 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)
• syncope
• dizziness
• 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)
• low sodium levels in the blood
• dehydration
• high levels of triglycerides (fats) 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
• decreased sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• 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 alsoreport them directly through the Spanish System for 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.

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.

Eplerenona Teva-ratio Composition

• 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 contents of the package

Coated tablet.

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

Eplerenona Teva-ratio 25 mg coated tablets EFG are available in opaque PVC/PVdC/Al blisters containing 10, 20, 28, 30, 50, 90, 100, and 200 tablets, and in single-dose opaque PVC/PVdC/Al blisters pre-cut containing 20 x 1, 30 x 1, 50 x 1, 90 x 1, 100 x 1, or 200 x 1 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer

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

Republic of Czech

Or

Merckle GmbH

Ludwig-Merckle-Strasse 3 89143 Blaubeuren

Germany

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

Spain:Eplerenona Teva-ratio 25 mg coated tablets EFG

Last revision date of this leaflet:november 2020

“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/”

You can access detailed and updated information on this medicinal product by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/77324/P_77324.html

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