Eplerenone Cinfamed 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Eplerenona Cinfamed 50 mg film-coated tablets EFG

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Eplerenona Cinfamed is and what it is used for
2. What you need to know before taking Eplerenona Cinfamed
3. How to take Eplerenona Cinfamed
4. Possible side effects
5. How to store Eplerenona Cinfamed
6. Contents of the pack and other information

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

Eplerenona 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 regulates blood pressure and heart function. High levels of aldosterone can cause changes in your body that may lead to heart failure.

This medicine is used to treat heart failure to prevent its worsening and reduce hospitalization in patients who have:

1. Recently had a myocardial infarction, in combination with other medicines used to treat their heart failure, or

2. Persistent mild symptoms, despite the treatment they have been receiving up to now.

2. What you need to know before taking 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 your blood (hyperkalaemia).
• If you are taking medicines from groups that help your body eliminate excess fluid (potassium-sparing diuretics) or "salt tablets" (potassium supplements).
• If you have severe renal impairment.
• If you have severe hepatic 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 for depression.
• If you are simultaneously taking medicines used to treat certain heart conditions or high blood pressure (such as angiotensin-converting enzyme [ACE] inhibitors and angiotensin receptor antagonists [ARA]).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine.

• If you have kidney or liver disease (see also “Do not take Eplerenone Cinfamed”)
• If you are taking lithium (commonly used for manic-depressive disorders, also called bipolar disorder)
• If you are taking tacrolimus or cyclosporine (used to treat skin conditions such as psoriasis or eczema and to prevent rejection of transplanted organs)

Children and adolescents

The safety and efficacy of eplerenone in children and adolescents has not been established.

Other medicines and Eplerenone Cinfamed

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

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for treating HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the metabolism of Eplerenone Cinfamed, thereby prolonging its effect in the body.

• Diuretics known as potassium-sparing diuretics (medicines that help eliminate excess fluid from the body) or potassium supplements (salt tablets), as these medicines increase the risk of developing high potassium levels in the blood.

• Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists (ARA) taken together (used to treat high blood pressure, heart disease, or certain kidney conditions), as these medicines may increase the risk of developing high potassium levels in the blood.

• Lithium (commonly used for manic-depressive disorders, also called bipolar disorder). The use of lithium together 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 lead to the following adverse effects: 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 rejection of transplanted organs). These medicines may cause kidney problems and thus increase the risk of developing high potassium levels in the blood.

• Non-steroidal anti-inflammatory drugs (NSAIDs – certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines 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 conditions), may lead to a drop in blood pressure and dizziness upon standing.

• Tricyclic antidepressants such as amitriptyline or amoxapine (for the treatment of depression), antipsychotics (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 drop in blood pressure and dizziness upon standing.

• Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions), and tetracosactide (used mainly to diagnose and treat adrenal cortex disorders), may reduce the blood pressure-lowering effect of Eplerenone Cinfamed.

• Digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with Eplerenone Cinfamed.

• Warfarin (an anticoagulant medicine): Caution is required when administering warfarin, as high levels of warfarin in the blood may be affected by changes caused by Eplerenone Cinfamed in the body.

• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for treating HIV infection), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for the treatment of heart problems and high blood pressure) may reduce the metabolism of Eplerenone Cinfamed, thereby prolonging its effect in the body.

• Hypericum perforatum or St. John's wort (herbal remedy), 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 may 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 become pregnant, consult your doctor or pharmacist before using this medicine.

The effect of this medicine during pregnancy has not been evaluated in humans.

It is unknown 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 occurs, 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 certain sugars, consult with him before taking this medicine.

Eplerenone Cinfamed contains sodium

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

3. How to take Eplerenone Cinfamed

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in 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 administered together with other medicines for heart failure, for example, beta-blockers. The usual starting dose is one 25 mg tablet once daily, which is subsequently increased after approximately 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 levels should be measured before starting treatment with this medicine, during the first week, and one month after starting treatment or after any dose adjustment. Your doctor may adjust the dose based on your blood potassium levels.

If you have mild renal impairment, you should start treatment with one 25 mg tablet daily. If you have moderate renal impairment, treatment should be initiated with one 25 mg tablet every other day. These doses may be adjusted, as directed by your doctor and according to your blood potassium levels. This medicine is not recommended for patients with severe renal disease.

No initial dose adjustment is required in patients with mild renal impairment or in patients with mild to moderate hepatic impairment. If you have any liver or kidney disease, you may require more frequent blood potassium monitoring (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, inform your doctor or pharmacist immediately. If you have taken too much medicine, the most likely symptoms are low blood pressure (manifested as dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalaemia, high levels of potassium in the blood (manifested by muscle cramps, diarrhoea, nausea, dizziness or headache).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 tablet at the scheduled time. Otherwise, take the tablet as soon as you remember, provided that more than 12 hours remain before the next scheduled dose. Then continue taking your medicine as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Eplerenone Cinfamed

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 angioedema, an uncommon adverse effect (affecting up to 1 in 100 people).

Other reported adverse effects include:

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

• elevated potassium levels in blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness or headache)
• dizziness
• fainting
• elevated cholesterol levels in blood
• insomnia (difficulty sleeping)
• headache
• heart problems, for example, irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasm
• increased levels of urea in blood
• elevated creatinine levels in blood, which may indicate kidney problems.

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

• infection
• eosinophilia (increase in certain white blood cells)
• low sodium levels in blood
• dehydration
• elevated levels of cholesterol or triglycerides (fats) in blood
• rapid heartbeat
• inflammation of the gallbladder
• drop in blood pressure that may cause dizziness upon standing
• thrombosis (blood clot) in the legs
• sore throat
• flatulence
• underactive thyroid
• increased blood glucose
• reduced sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in certain blood tests.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Eplerenona Cinfamed

• The active substance is eplerenone. Each tablet contains 50 mg of eplerenone.
• The other components are monohydrate lactose, microcrystalline cellulose (type 101), sodium croscarmellose, hypromellose (type 2910), microcrystalline cellulose (type 102), sodium lauryl sulfate, talc, magnesium stearate (tablet core);

Opadry II white OY-L-28900: monohydrate lactose, hypromellose (type 2910), titanium dioxide (E171), macrogol 4000 (film coating).

Appearance of the product and contents of the container

Eplerenona Cinfamed 50 mg film-coated tablets are white to almost white, round, biconvex tablets, marked "CG4" on one side and smooth (unmarked) on the other side.

Eplerenona Cinfamed 50 mg film-coated tablets EFG are supplied in cardboard boxes with PVC/aluminum blisters containing 30 or 50 film-coated tablets.

Only certain 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 the most recent revision of this package leaflet: January 2022.

Detailed and up-to-date information on this medicinal product 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 with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76274/P_76274.html

QR code link: https://cima.aemps.es/cima/dochtml/p/76274/P_76274.html