Package Insert: Information for the Patient

Eplerenona Cinfamed 25 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 for you only, 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.

6. Contents of the pack and additional information

EplerenonaCinfamedbelongs 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 may lead to heart failure.

This medication 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.Slight persistent symptoms, despite the treatment you have been receiving up to this point.

Do not take Eplerenona Cinfamed

• If you are allergic to eplerenone or any of the other ingredients 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) or "salt tablets" (potassium supplements).
• 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 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 ARBs) at the same time.

Warnings and precautions

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

• If you have kidney or liver disease (also see "Do not take Eplerenona Cinfamed")
• 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 eplerenone have not been established in children and adolescents.

Other medications and Eplerenona Cinfamed

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 Cinfamed, prolonging its effect in the body.
• Potassium-sparing diuretics or potassium supplements (also known as "salt tablets"), as these medications increase the risk of high potassium levels in the blood.
• ACE inhibitors and ARBs (used to treat high blood pressure, heart disease, or certain kidney diseases) at the same time, as these medications may increase the risk of high potassium levels in the blood.

• Lithium (used to treat manic-depressive disorders, also known as bipolar disorder). The use of lithium with diuretics and ACE inhibitors 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 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 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 Cinfamed.
• Digoxin (used to treat heart conditions). The levels of digoxin in the blood may increase when taken with Eplerenona Cinfamed.
• Warfarin (an anticoagulant medication): Caution is required when administering warfarin doses, as high levels of warfarin in the blood may cause changes to Eplerenona Cinfamed 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 Cinfamed, prolonging its effect in the body.
• St. John's Wort (Hypericum perforatum) or St. John's Wort extract, rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy) may increase the metabolism of Eplerenona Cinfamed and reduce its effect.

Administration of Eplerenona Cinfamed with food and drinks

Eplerenona Cinfamed can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The effect of this medication on human pregnancy has not been evaluated.

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

Driving and operating machinery

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

Eplerenona Cinfamed contains lactose

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

Eplerenona Cinfamed contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; 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.

TheEplerenonaCinfamedtablets can be takenwith or without food. Swallow the tablets whole with plenty of water.

EplerenonaCinfamedis 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.

Blood potassium determinations should be performed before starting treatment with this medication, during the first week, and one month after starting treatment or after a change in dose. Your doctor may 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. This medication is not recommended for patients with severe renal disease.

No initial dose adjustment is necessary for patients with mild renal insufficiency, nor for patients with mild to moderate hepatic 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 Cinfamed”).

In elderly patients: no initial dose adjustment is required.

In children and adolescents:Eplerenona Cinfamedis not recommended.

If you take more Eplerenona Cinfamed than you should

If you take more Eplerenona Cinfamed 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 Cinfamed

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 next scheduled dose. Resume your medication as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eplerenona Cinfamed

It is essential to continue takingEplerenona Cinfamedas 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 medications,this medicationcan 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):

• high levels of potassium in the blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• dizziness
• syncope (fainting)
• 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
• increased levels of urea in the blood
• elevated levels of creatinine in the blood that may indicate kidney problems.

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

• infection
• eosinophilia (increased levels of certain white blood cells)
• low sodium levels in the blood
• dehydration
• high levels of cholesterol or 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
• hypothyroidism (underactive thyroid)
• increased glucose levels in the blood
• diminished sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• inflammation of the kidneys
• gynecomastia (enlargement of the breasts) in men
• changes in certain blood tests.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: http://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 conditions for conservation.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Eplerenona Cinfamed

• The active ingredient is eplerenone. Each tablet contains 25 mg of eplerenone.
• The other components are lactose monohydrate, microcrystalline cellulose (type 101), sodium croscarmellose, hypromellose (type 2910), microcrystalline cellulose (type 102), sodium lauryl sulfate, talc, magnesium stearate (core of the tablet); Opadry II white OY-L-28900: lactose monohydrate, hypromellose (type 2910), titanium dioxide (E171), macrogol 4000 (tablet coating).

Appearance of the product and contents of the packaging

Eplerenona Cinfamed 25 mg film-coated tablets are white to off-white, round, biconvex tablets, marked “CG3” on one face of the tablet and smooth (unmarked) on the other face.

Eplerenona Cinfamed 25 mg film-coated tablets are presented in packs with blisters of PVC/aluminium containing 30 or 50 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Cinfa Laboratories, S.A

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible manufacturer:

Liconsa Laboratories, S.A

Miralcampo Avenue 7, Miralcampo Industrial Estate

19200 Azuqueca de Henares, Guadalajara, Spain

Last review date of this leaflet:January 2022.

Detailed and updated information on this medicine 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 medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/76273/P_76273.html

QR code link to:https://cima.aemps.es/cima/dochtml/p/76273/P_76273.html