Package Insert: Information for the User

Eplerenona Tarbis Farma 25 mg Film-Coated Tablets

Eplerenona Tarbis Farma 50 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should 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 package insert. See section 4.

Eplerenona belongs to a group of medications known as selective aldosterone blockers. These blockers inhibit the action of aldosterone, a substance produced by the body that controls blood pressure and cardiac function. Elevated levels of aldosterone can produce changes in the body that lead to heart failure.

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

1.a recent myocardial infarction, in combination with other medications used to treat your heart failure or

2. persistent mild symptoms, despite the treatment you have been receiving up to this point.

Do not take Eplerenona Tarbis Farma

• 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 medications used to treat HIV infections (ritonavir or nelfinavir)
• 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 ACE inhibitors and ARAs) at the same time.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take eplerenona.

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

Use of Eplerenona Tarbis Farma with other medications

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

• Itraconazole or ketoconazole (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 thus 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 ARAs 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 disorders, 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 excessively high levels of lithium in the blood, which may cause the following adverse reactions: 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 organ transplant rejection). These medications may cause kidney problems and thus increase the risk of high potassium levels in the blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs – certain analgesics such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medications may 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 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 cortex diseases) may reduce the blood pressure-lowering effect of Eplerenona Tarbis Farma.
• Digoxin (used to treat heart conditions). The levels of digoxin in the blood may increase when taken with Eplerenona Tarbis Farma.
• Warfarin (an anticoagulant medication): Caution is required when administering warfarin doses, as high levels of warfarin in the blood may cause modifications to the effect of Eplerenona Tarbis Farma in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medication for HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart conditions and high blood pressure) may reduce the metabolism of eplerenona, prolonging its effect in the body.
• St. John's Wort (Hypericum perforatum), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy, among other conditions) may increase the metabolism of eplerenona and thus reduce its effect.

Taking Eplerenona Tarbis Farma with food and drinks

Eplerenona Tarbis Farma can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. Eplerenona has not been evaluated for its effect on human pregnancy.

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

Driving and operating machinery

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

Eplerenona Tarbis Farma contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Eplerenona Tarbis Farma contains sodium

Eplerenona Tarbis Farma contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Eplerenona Tarbis Farma tablets can be taken with or without food. Swallow the tablets whole with plenty of water.

Eplerenona is usually administered together with other medications for heart failure, for example, beta-blockers. The usual 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.

Measurements of potassium in the blood should be performed before starting treatment with Eplerenona Tarbis Farma, during the first week, and one month after starting treatment or after a change in dosage. Your doctor may adjust the dose based on your blood potassium levels.

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 in accordance with your blood potassium levels.

Eplerenona is not recommended for patients with severe kidney disease.

No initial dose adjustment is necessary in patients with mild to moderate liver insufficiency. If you have any liver or kidney disease, you may need to have your blood potassium levels checked more frequently (see also "Do not take Eplerenona Tarbis Farma").

In elderly patients: no initial dose adjustment is required.

In children and adolescents:Eplerenona Tarbis Farmais not recommended.

If you take more Eplerenona Tarbis Farma than you should

If you take more Eplerenona Tarbis Farma than you should, inform 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 Tarbis Farma

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

Otherwise, take the tablet as soon as you remember, provided it has been more than 12 hours since the time you were supposed to take the next tablet. Resume your medication as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eplerenona Tarbis Farma

It is essential to continue taking Eplerenona Tarbis Farma as 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 medicine may cause side effects, although not everyone will experience them.

If any of the following occur:

Seek immediate medical attention

• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Blisters and difficulty breathing

These are symptoms of angioneurotic edema, a rare side effect (affecting up to 1 in 100 people).

Other reported side effects include:

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

• Elevated potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• Fainting
• Dizziness
• High cholesterol levels 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
• Rash
• Itching
• Back pain
• Weakness
• Muscle spasms
• Increased urea levels in the blood
• Elevated creatinine levels in the blood that may indicate kidney problems

Rare side effects(may affect up to 1 in 100 people):

• Infection
• Eosinophilia (increase in certain white blood cells)
• Low sodium levels in the blood
• Dehydration
• Elevated triglyceride levels (fats) in the blood
• Fast 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
• Increased blood glucose
• Decreased sense of touch
• Increased sweating
• Musculoskeletal pain
• General malaise
• Kidney inflammation
• Increased breast tissue 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 possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the 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 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 outer carton after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed ofthrough drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Eplerenone Tarbis Farma Composition

The active ingredient is eplerenone.

Each Eplerenone Tarbis 25mg film-coated tablet contains 25 mg of eplerenone.

Each Eplerenone Tarbis 50mg film-coated tablet contains 50 mg of eplerenone.

The other ingredients are:

Core:Lactose monohydrate, microcrystalline cellulose (E460), sodium lauryl sulfate, sodium croscarmellose (E468), hypromellose (E464), talc (E553b), and magnesium stearate (E470b).

Coating:Hypromellose (E464), titanium dioxide (E171), macrogol (E1521), polysorbate 80 (E433), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of Eplerenone Tarbis Farma and packaging contents

Film-coated tablets.

Eplerenone Tarbis Farma 25 mg film-coated tablets EFG

Film-coated, round, biconvex, yellowish, approximately 6.0 mm in diameter and 3.0 mm in thickness, engraved with a "V" on one face and "68" on the other face.

Eplerenone Tarbis Farma 50 mg film-coated tablets EFG

Film-coated, round, biconvex, yellowish, approximately 8.0 mm in diameter and 3.5 mm in thickness, engraved with a "V" on one face and "67" on the other face.

Eplerenone Tarbis Farma The 25 mg and 50 mg film-coated tablets are available in PVC/Al white opaque blisters containing 20, 30, 50, 90, 100, or 250 tablets.

HDPE containers: 30 and 90 tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Eplerenone Amarox 25 mg/50 mg Filmtabletten

Spain:Eplerenone Tarbis Farma 25 mg/50 mg film-coated tablets EFG

Netherlands:Eplerenon Amarox 25 mg/50 mg, filmomhulde tabletten

Last review date of this leaflet:

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es