EPLERENONE TEVA-RATIO 25 mg FILM-COATED TABLETS

2. What you need to know before taking Eplerenona Teva-ratio

Do not takeEplerenona Teva-ratio

• if you are allergic to eplerenone or any of the other components 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 kidney failure
• if you have severe liver failure
• if you are taking 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 to treat depression
• if you are taking medicines used to treat certain heart diseases or high blood pressure (such as angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs)) at the same time.

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-ratio”)
• if you are taking lithium (used to treat manic-depressive disorder, also known as 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-ratio with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicines.

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for HIV treatment), 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 potassium levels in the blood.
• Angiotensin-converting enzyme inhibitors (ACEIs) 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 potassium levels in the blood.

• Lithium (used to treat manic-depressive disorder, also known as bipolar disorder). The use of lithium with diuretics and ACE inhibitors has been shown to cause high lithium levels 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 potassium levels in the blood.
• Non-steroidal anti-inflammatory medicines (NSAIDs - certain pain relievers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines can cause kidney problems and thus 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 lead to a decrease in blood pressure and dizziness when standing up.
• Tricyclic antidepressants, such as amitriptyline or amoxapine (for depression treatment), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (for psychiatric disorder treatment), 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.
• Glucocorticoids, 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 heart disease treatment). Blood levels of digoxin may increase when taken with eplerenone.
• Warfarin (an anticoagulant medicine): caution is required when administering warfarin doses, as high warfarin levels in the blood may affect 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 heart problems and high blood pressure treatment) reduce the metabolism of eplerenone, thus prolonging its effect in the body.
• St. John's Wort (a herbal medicine), 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-ratio with food and drinks

Eplerenona Teva-ratio can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any 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 interrupt breastfeeding or suspend treatment.

Driving and using machines

After taking Eplerenona Teva-ratio, 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 certain sugars, consult with them before taking this medicine.

Sodium

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

3. How to take Eplerenona Teva-ratio

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

Eplerenona Teva-ratio film-coated 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 medicines for heart failure, such as 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 one month after starting treatment or after a dose change. Your doctor may adjust the dose based on your potassium levels in the blood.

If you have mild kidney failure, you should start treatment with one 25 mg tablet per day, and if you have moderate kidney failure, you should start treatment with one 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 liver failure. 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-ratio”).

In elderly patients, no initial dose adjustment is required.

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 medicine, the most likely symptoms will be low blood pressure (manifested as dizziness, blurred vision, weakness, sudden loss of consciousness) or hyperkalemia, high potassium levels 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 ingested.

If you forget to take Eplerenona Teva-ratio

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

Otherwise, take the tablet as soon as you remember, provided that it is more than 12 hours until the time to take the next tablet. Go back to taking your medicine as usual.

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

If you stop taking Eplerenona Teva-ratio

It is important to keep taking Eplerenona Teva-ratio as 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.

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 potassium levels in the blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• fainting
• dizziness
• high cholesterol levels in the blood
• insomnia (difficulty sleeping)
• headache
• heart problems, such as irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasms
• increased urea levels in the blood
• increased creatinine levels 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)
• low sodium levels in the blood
• dehydration
• high triglyceride levels 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
• increased 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 side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website, 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-ratio

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

This medicine does not require 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Eplerenona Teva-ratio

• The active substance 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 package contents

Film-coated tablet.

The film-coated tablets are yellow, 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 film-coated tablets EFG are available in opaque PVC/PVdC/Al blisters containing 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.

Not all 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 1ª planta

28108 Alcobendas, Madrid (Spain)

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

Czech Republic

Or

Merckle GmbH

Ludwig-Merckle-Strasse 3 89143 Blaubeuren

Germany

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

Spain: Eplerenona Teva-ratio 25 mg film-coated tablets EFG

Date of the last revision of this leaflet:November 2020

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/ "

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging 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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