Leaflet: information for the user

Eplerenona MABO 50 mg film-coated tablets

Read this leaflet carefully before you start taking the medicine, as it contains important information for you

• Keep this leaflet, 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 and should not be given 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 leaflet. See section 4.

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

2. What you need to know before starting to take Eplerenona MABO

3. How to take Eplerenona MABO

4. Possible side effects

5. Storage of Eplerenona MABO

6. Contents of the pack and additional information

Eplerenona MABO 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 may lead to heart failure.

Eplerenona MABO 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 MABO

• if you areallergic to eplerenone or to any of the other ingredientsof this medication (listed in section 6).
• if you havehigh levels of potassiumin your blood (hyperkalemia).
• if you are takingmedications that help your body get rid of excess fluids(potassium-sparing diuretics).
• if you havesevere kidney disease.
• if you havesevere liver disease.
• if you are takingmedications usedto treat fungal infections

(ketoconazole or itraconazole).

• if you are takingmedications used to treat HIV infection(ritonavir or nelfinavir).
• if you are takingantibiotics used to treat bacterial infections (clarithromycin or

telithromycin).

• if you are taking nefazodoneto treat depression.
• if you are takingmedications used to treat certain heart or high blood pressure conditions (such as ACE inhibitors and angiotensin receptor blockers).

Warnings and precautions

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

• if you havekidney or liver disease(also see “Do not take Eplerenona MABO”).
• if you are taking lithium(usually used to treat manic-depressive disorder, 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).

Use of Eplerenona MABO 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) ornefazodone(used to treat depression), as these medications reduce eplerenone metabolism, and thus prolong its effect in the body.
• Diuretics that spare potassium(medications that help your body get rid of excess fluids) andpotassium supplements(salt tablets), as these medications increase the risk of high potassium levels in your blood.
• ACE inhibitors and angiotensin receptor blockers(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 your blood.
• Lithium(usually used to treat manic-depressive disorder, 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 lithium levels in the blood, which may cause the following adverse reactions: loss of appetite, vision changes, fatigue, muscle weakness, and muscle cramps.
• Tacrolimus or cyclosporine(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 your blood.
• Nonssteroidal anti-inflammatory drugs (NSAIDs) – certain pain relievers like ibuprofen, used to relieve pain, stiffness, and inflammation. These medications may cause kidney problems and thus increase the risk of high potassium levels in your blood.
• Trimethoprim(used to treat bacterial infections) may increase the risk of high potassium levels in your blood.
• Alpha-1 blockers, such as prazosin or alfuzosin(used to treat high blood pressure and certain prostate conditions) may cause a decrease in blood pressure and dizziness when standing up.
• Tricyclic antidepressants(such as amitriptyline or amoxapine) (for depression treatment),antipsychotics(also known asneuroleptics) (such as chlorpromazine or haloperidol) (for psychiatric disorder treatment),amifostine(used during cancer chemotherapy) andbaclofen(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) andtetracosactide(used mainly to diagnose and treat adrenal cortex disorders) may reduce the blood pressure-lowering effect of eplerenone.
• Digoxin(used to treat heart conditions). Eplerenone levels in the blood may increase when taken with digoxin.
• Warfarin(an anticoagulant medication): Caution is required when administering warfarin doses, as high warfarin levels in the blood may cause changes in eplerenone's effect on the body.
• Erythromycin(used to treat bacterial infections),saquinavir(an antiviral medication for HIV),fluconazole(used to treat fungal infections),amiodarone,diltiazem, andverapamil(used to treat heart conditions and high blood pressure) may reduce eplerenone metabolism, prolonging its effect in the body.
• St. John's Wort (Hypericum perforatum),rifampicin(used to treat bacterial infections),carbamazepine,phenytoin, andphenobarbital(used, among others, to treat epilepsy) may increase eplerenone metabolism and thus reduce its effect.

Taking Eplerenona MABO with food and drinks

Eplerenone 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. Eplerenone has not been evaluated in humans during pregnancy.

The doctor will decide with you whether to interrupt treatment or breastfeeding.

Driving and operating machinery

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

Eplerenona MABO 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 MABO contains sodium

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

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

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

Eplerenone 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 eplerenone, 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 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 in accordance with your potassium blood levels.

Eplerenone is not recommended for patients with severe kidney disease.

No initial dose adjustment is required for patients with mild to moderate liver insufficiency. If you have any liver or kidney disease, you may need to have your potassium blood levels checked more frequently (see also “Do not take Eplerenone MABO”).

In elderly patients: no initial dose adjustment is required.

In children and adolescents: eplerenone is not recommended.

If you take more Eplerenone MABO than you should

If you take more eplerenone 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Eplerenone MABO

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

Otherwise, take the tablet as soon as you remember, as long as more than 12 hours have elapsed since the usual time for taking 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 Eplerenone MABO

It is essential to continue taking eplerenone 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:

Side effectsCommon(may affect up to 1 in 10 people):

• High levels of potassium in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• Dizziness
• 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
• Rash
• 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.

Side effectsRare(may affect up to 1 in 100 people):

• Infection
• Eosinophilia (increase in certain white blood cells)
• Dehydration
• High levels of triglycerides (fats) in the blood
• Low levels of sodium 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 discomfort
• Renal inflammation
• Enlargement of breasts in men
• Changes in certain blood tests

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, 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 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 out of sight and reach of children.

Do not use Eplerenona MABO after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of medications through drains or trash. Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Composition ofEplerenonaMABO

• The active ingredient is eplerenone. Each tablet contains 50mg of eplerenone.
• The other components are lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), sodium lauryl sulfate, talc (E553b), magnesium stearate (tablet core); hypromellose (E464), poloxamer 80 (E433), macrogol 400, titanium dioxide (E171), yellow iron oxide (E172) (tablet coating).

Appearance of the productand content of the container:

50mg tablet: coated tablet with a light yellow film, round, biconvex, marked with “E9RN” on one face and “50” on the other.

Eplerenone MABO is available in blister packs of 30 tablets.

Marketing authorization holderand manufacturer

Marketing authorization holder:

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer:

Synthon Hispania S.L.

C/ Castelló nº1, Pol. Las Salinas, Sant Boi de Llobregat,

08830 Barcelona

Spain

Or

Synthon BV

Microweg 22

6545 CM, Nijmegen

Netherlands

Last review date of this leaflet: February 2018

The 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/