Package Insert: Information for the User

Eplerenone MABO 25 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

1. What is Eplerenone MABO and how is it used

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

3. How to take Eplerenone MABO

4. Possible adverse effects

5. Storage of Eplerenone MABO

6. Contents of the package 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 medicine (listed in section 6).
• if you havehigh levels of potassiumin your blood (hyperkalemia).
• if you are takingmedicines 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 takingmedicines usedto treat fungal infections

• (ketoconazole or itraconazole).
• if you are takingmedicines used to treat HIV infection(ritonavir or nelfinavir).
• if you are takingantibioticsused to treat bacterial infections (clarithromycin or
• telithromycin)
• if you are taking nefazodoneto treat depression.
• if you are takingmedicines used to treat certain heart or high blood pressure conditions (such as ACE inhibitors and angiotensin receptor antagonists).

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 disorders, also known as bipolar disorder).

if you are taking tacrolimus or cyclosporin(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.

Use of Eplerenona MABO with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or might have to take any other medicine.

• ketoconazole or itraconazole(used to treat fungal infections),ritonavir,nelfinavir(antiviral medicines for HIV treatment),clarithromycin,telithromycin(used to treat bacterial infections) ornefazodone(used to treat depression), as these medicines reduce the metabolism of eplerenone, and thus prolong its effect in the body.
• potassium-sparing diuretics(medicines that help your body get rid of excess fluids) andpotassium supplements(tablets), as these medicines increase the risk of high potassium levels in your 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 potassium levels in your blood.

• lithium(usually used to treat manic-depressive disorders, also known as 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 cause the following adverse reactions: loss of appetite, visual disturbances, fatigue, muscle weakness, and muscle cramps.
• tacrolimus or cyclosporin(used to treat skin conditions such as psoriasis or eczema, and to prevent organ transplant rejection). These medicines may cause kidney problems and thus increase the risk of high potassium levels in your blood.
• non-steroidal anti-inflammatory drugs (NSAIDs) – certain painkillers like ibuprofen, used to relieve pain, stiffness, and inflammation. These medicines 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 diseases) may lead to a decrease in blood pressure and the appearance of dizziness when standing up.
• tricyclic antidepressantssuch as amitriptyline or amoxapine (for the treatment of depression),antipsychotics(also known asneuroleptics) (such as chlorpromazine or haloperidol) (for the treatment of psychiatric disorders),amifostine(used during cancer chemotherapy) andbaclofen(used to treat muscle spasms). These medicines may lead to a decrease in blood pressure and the appearance of dizziness when standing up.
• glucocorticoids(such as hydrocortisone or prednisone) (used to treat inflammation and certain skin diseases) andtetracosactide(used mainly to diagnose and treat adrenal cortex diseases) may reduce the blood pressure-lowering effect of eplerenone.
• digoxin(used in the treatment of heart diseases). The blood levels of digoxin may increase when taken with eplerenone.
• warfarin(an anticoagulant): Caution is required when administering warfarin doses, as high levels of warfarin in the blood may cause modifications of the effect of eplerenone in the body.
• erythromycin(used to treat bacterial infections),saquinavir(an antiviral medicine for HIV treatment),fluconazole(used to treat fungal infections),amiodarone,diltiazem,andverapamil(used to treat heart problems and high blood pressure) by reducing the metabolism of eplerenone, thus prolonging its effect in the body.
• Hypericum perforatum or St. John's Wort(a medicinal plant),rifampicin(used to treat bacterial infections),carbamazepine,phenytoin,andphenobarbital(used, among others, to treat epilepsy) may increase the metabolism of eplerenone 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 might be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Eplerenone has not been evaluated in humans during pregnancy.

We do not know if eplerenone is excreted in breast milk. Your 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 medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Eplerenona MABO contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablets; 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.

Blood potassium determinations 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 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.

Eplerenone is not recommended for patients with severe renal disease.

No initial dose adjustment is necessary in 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 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 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 taking 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 medications, this medication 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:

Common 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)
• Dizziness
• Fainting
• 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

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

• Infection
• Eosinophilia (increase in certain white blood cells)
• Dehydration
• High levels of cholesterol or triglycerides (fats) in the blood
• Low sodium levels 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
• Renal inflammation
• Enlargement of the 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 not listed 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 medication.

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. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

Composition ofEplerenona MABO

• The active ingredient is eplerenone. Each tablet contains 25mg 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), polysorbate 80 (E433), macrogol 400, titanium dioxide (E171), iron oxide yellow (E172) (tablet coating).

Appearance of the productand content of the container:

25mg tablet: coated tablet with a light yellow film, round, biconvex, marked with “E9RN” on one face and “25” on the other.

Eplerenona MABO is available in blister packs of 30 tablets.

Only some container sizes may be marketed.

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/