EPLERENONE MABO 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eplerenone MABO 50 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 pack and other information:

1. What is Eplerenone MABO and what is it used for
2. What you need to know before you take Eplerenone MABO
3. How to take Eplerenone MABO
4. Possible side effects
5. Storage of Eplerenone MABO
6. Contents of the pack and further information

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

Eplerenone MABO 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.

Eplerenone 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 medicines used to treat your heart failure or
2. mild persistent symptoms, despite the treatment you have been receiving so far.

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

Do not take Eplerenone MABO

• 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 (hyperkalemia).
• if you are taking medicines that help your body get rid of excess fluid (potassium-sparing diuretics)
• if you have severe kidney problems.
• if you have severe liver problems.
• 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 Eplerenone MABO.

• if you have kidney or liver disease (see also “Do not take Eplerenone MABO”)
• 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 transplant rejection).

Using Eplerenone MABO with other medicines

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 for HIV treatment), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (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 fluid) and potassium supplements (salt tablets), as these medicines increase the risk of high levels of potassium 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 levels of potassium in your blood.
• Lithium (used to treat manic-depressive disorder, 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 transplant rejection). 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 your blood.
• Trimethoprim (used to treat bacterial infections) may increase the risk of high levels of potassium 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 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.
• Digoxin (used to treat heart diseases). Blood levels of digoxin may increase when taken with eplerenone.
• Warfarin (an anticoagulant medicine): Caution is required when administering warfarin doses, as high levels of warfarin in the blood may alter 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, and verapamil (for the treatment of heart problems and high blood pressure), as they reduce 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, and phenobarbital (used, among others, to treat epilepsy), may increase the metabolism of eplerenone and thus reduce its effect.

Taking Eplerenone 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The effect of eplerenone 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 stop treatment or breastfeeding.

Driving and using machines

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

Eplerenone MABO contains lactose

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

Eplerenone MABO contains sodium

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

3. How to take Eplerenone MABO

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 given together with other medicines for heart failure, such as beta-blockers. The usual initial dose is one 25 mg tablet once a day, 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 tests should be performed before starting treatment with eplerenone, during the first week, and after one month of starting treatment or after a dose change. Your doctor may adjust the dose based on your potassium blood levels.

If you have mild kidney problems, you should start treatment with one 25 mg tablet per day, and if you have moderate kidney problems, you should start treatment with one 25 mg tablet every other day. These doses may be adjusted, if your doctor indicates, and according to your potassium blood levels.

Eplerenone is not recommended in patients with severe kidney disease.

No initial dose adjustment is necessary in patients with mild to moderate liver problems. If you have any liver or kidney disease, you may need to have potassium blood tests performed 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, 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 MABO

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 more than 12 hours remain until the next dose. Resume taking your medicine as usual. Do not take a double dose to make up for missed doses.

If you stop taking Eplerenone MABO

It is important to keep taking eplerenone as your doctor indicated, unless your doctor tells you to stop treatment.

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:

Frequentside effects (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
• heart problems, such as irregular heartbeat 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.

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

• infection
• eosinophilia (an increase in certain white blood cells)
• dehydration
• high levels of triglycerides (fats) in the blood
• low levels of sodium 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, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone MABO

Keep out of the sight and reach of children.

Do not use Eplerenone MABO after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Eplerenone MABO

• The active substance is eplerenone. Each tablet contains 50 mg of eplerenone.
• The other ingredients 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), yellow iron oxide (E172) (tablet coating).

Appearance and packaging of the product:

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

Eplerenone MABO is available in blister packs of 30 tablets.

Marketing authorization holder and 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

Date of last revision of this leaflet: February 2018

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/