EPLERENONE CINFAMED 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Eplerenone Cinfamed 25 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Eplerenone Cinfamed and what is it used for
2. What you need to know before you take Eplerenone Cinfamed
3. How to take Eplerenone Cinfamed
4. Possible side effects
5. Storage of Eplerenone Cinfamed

1. Contents of the pack and further information

1. What is Eplerenone Cinfamed and what is it used for

Eplerenone Cinfamed belongs to a group of medicines 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. High levels of aldosterone can cause changes in your body that lead to heart failure.

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

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

1. Mild persistent symptoms, despite the treatment you have been receiving so far.

2. What you need to know before you take Eplerenone Cinfamed

Do not take Eplerenone Cinfamed

• If you are allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6).
• If you have high levels of potassium in the blood (hyperkalemia).
• If you are taking medicines from groups that help eliminate excess fluid in the body (potassium-sparing diuretics) or "salt tablets" (potassium supplements).
• If you have severe kidney impairment.
• If you have severe liver impairment.
• If you are taking medicines used to treat fungal infections (ketoconazole or itraconazole).
• If you are taking medicines used to treat HIV infection (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 medicines used to treat certain heart diseases or high blood pressure (such as ACE inhibitors and angiotensin receptor antagonists) at the same time.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with this medicine.

• If you have kidney or liver disease (see also "Do not take Eplerenone Cinfamed")
• If you are taking lithium (used to treat manic-depressive disorders, also called bipolar disorder)
• If you are taking tacrolimus or cyclosporin (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.

Other medicines and Eplerenone Cinfamed

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

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines used to treat HIV), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression), as these medicines reduce the metabolism of Eplerenone Cinfamed, 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 levels of potassium in the blood.
• ACE inhibitors and angiotensin receptor antagonists (used to treat high blood pressure, heart disease, or certain kidney diseases) at the same time, as these medicines may increase the risk of high levels of potassium in the blood.

• Lithium (used to treat manic-depressive disorders, also called bipolar disorder). The use of lithium with diuretics and ACE inhibitors has been shown to cause high levels of lithium in the blood, which can cause the following adverse reactions: loss of appetite, vision changes, fatigue, muscle weakness, and muscle cramps.
• Cyclosporin 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 levels of potassium in the blood.
• Non-steroidal anti-inflammatory medicines (NSAIDs - certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines can cause kidney problems and thus increase the risk of high levels of potassium in the blood.
• Trimethoprim (used to treat bacterial infections) may increase the risk of high levels of potassium 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 the treatment of depression), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (for the treatment of psychiatric disorders), 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.
• Corticosteroids, 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 Cinfamed.
• Digoxin (used to treat heart diseases). Blood levels of digoxin may increase when taken with Eplerenone Cinfamed.
• Warfarin (an anticoagulant medicine): caution is required when administering warfarin doses, as high levels of warfarin in the blood may cause changes in Eplerenone Cinfamed in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine used to treat HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for the treatment of heart problems and high blood pressure), as they reduce the metabolism of Eplerenone Cinfamed, thus prolonging its effect in the body.
• Hypericum perforatumor St. John's Wort (a medicinal plant), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy), may increase the metabolism of Eplerenone Cinfamed and thus reduce its effect.

Taking Eplerenone Cinfamed with food and drinks

Eplerenone Cinfamed can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The effect of this medicine 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 discontinue treatment or breastfeeding.

Driving and using machines

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

Eplerenone Cinfamed contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Eplerenone Cinfamed contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Eplerenone Cinfamed

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

Eplerenone Cinfamed tablets can be taken with or without food. Swallow the tablets whole with plenty of water.

Eplerenone Cinfamed is usually given together with other medicines for heart failure, for example, beta-blockers. The usual initial dose is one 25 mg tablet once daily, increasing later 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 blood levels should be determined before starting treatment with this medicine, 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 blood levels.

If you have mild kidney impairment, you should start treatment with a 25 mg tablet per day, and if you have moderate kidney impairment, you should start treatment with a 25 mg tablet every other day. These doses may be adjusted if your doctor indicates and according to your potassium blood levels. This medicine is not recommended in patients with severe kidney disease.

No initial dose adjustment is necessary in patients with mild kidney impairment or in patients with mild to moderate liver impairment. If you have any liver or kidney disease, it may be necessary to perform potassium blood level determinations more frequently (see also "Do not take Eplerenone Cinfamed").

In elderly patients: no initial dose adjustment is required.

In children and adolescents: Eplerenone Cinfamed is not recommended.

If you take more Eplerenone Cinfamed than you should

If you take more Eplerenone Cinfamed than you should, tell 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 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eplerenone Cinfamed

If it is almost time for your next dose, skip the missed dose and take the next dose at the scheduled time. Otherwise, take the dose as soon as you remember, provided that it is more than 12 hours until the next dose. Go back to taking your medicine as usual. Do not take a double dose to make up for missed doses.

If you stop taking Eplerenone Cinfamed

It is important to keep taking Eplerenone Cinfamed as your doctor has told you, unless your doctor tells you to stop. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen:

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 (affecting up to 1 in 100 people).

Other reported side effects include:

Common 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
• fainting
• high levels of cholesterol in the blood
• insomnia (difficulty sleeping)
• headache
• heart problems, such as irregular heartbeats and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasms
• increased levels of urea in the blood
• increased levels of creatinine in the blood, which may indicate kidney problems.

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

• infection
• eosinophilia (an increase in certain white blood cells)
• low levels of sodium in the blood
• dehydration
• high levels of cholesterol or triglycerides (fats) 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Cinfamed

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Eplerenone Cinfamed

• The active substance is eplerenone. Each tablet contains 25 mg of eplerenone.
• The other ingredients are lactose monohydrate, microcrystalline cellulose (type 101), croscarmellose sodium, 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 pack contents

Eplerenone Cinfamed 25 mg film-coated tablets are white to almost white, round, biconvex tablets, marked "CG3" on one side of the tablet and smooth (unmarked) on the other side.

Eplerenone Cinfamed 25 mg film-coated tablets EFG are available in packs with PVC/aluminum blisters containing 30 or 50 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avenida Miralcampo 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara, Spain

Date of last revision of this leaflet:January 2022.

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