Eplerenone Mabo 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eplerenone MABO 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. 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, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Eplerenone MABO is and what it is 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 regulates blood pressure and heart function. Elevated levels of aldosterone can cause changes in the body that may lead to heart failure.

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

1. recently suffered 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 starting to take Eplerenone MABO

Do not take Eplerenone MABO

• if you are allergic to eplerenone or to 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 from groups that help your body eliminate excess fluid (potassium-sparing diuretics).
• 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 hypertension (such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARBs)).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Eplerenone MABO.

• if you have kidney or liver disease (see also "Do not take Eplerenone MABO")
• if you are taking lithium (commonly used for manic-depressive disorder, also called bipolar disorder)
• if you are taking tacrolimus or cyclosporine (used to treat skin diseases such as psoriasis or eczema, and to prevent rejection of transplanted organs).

Use of Eplerenone MABO with other medicines

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, thereby prolonging its effect in the body.
• Potassium-sparing diuretics (medicines that help eliminate excess fluid from the body) and potassium supplements (salt tablets), as these medicines increase the risk of developing high potassium levels in your blood.
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARBs) taken together (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medicines may increase the risk of developing high potassium levels in the blood.
• Lithium (commonly used for manic-depressive disorder, 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 reactions: loss of appetite, vision disturbances, fatigue, muscle weakness, and muscle cramps.
• Cyclosporine or tacrolimus (used to treat skin diseases 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 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 lead to a drop in blood pressure and dizziness upon standing.
• Tricyclic antidepressants (such as amitriptyline or amoxapine) (for treatment of depression), antipsychotics (also known as neuroleptics) (such as chlorpromazine or haloperidol) (for 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 diseases) and tetracosactide (used mainly to diagnose and treat adrenal cortex disorders), may reduce the blood pressure-lowering effect of eplerenone.
• Digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with eplerenone.
• Warfarin (an anticoagulant medicine): Caution is required when administering warfarin doses, as high levels of warfarin in the blood may cause changes in the effect of eplerenone in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for treating HIV infections), 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, 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 and thus reduce its effect.

Taking Eplerenone MABO with food and drink

Eplerenone may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. The effect of eplerenone 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

You may feel dizzy after taking eplerenone. If this occurs, do not drive or operate machinery.

Eplerenone MABO contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Eplerenone MABO contains sodium

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

3. How to take Eplerenone MABO

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Eplerenone tablets may 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 starting dose is one 25 mg tablet once daily, increasing 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 eplerenone, 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, according to your blood potassium levels.

Eplerenone is not recommended in patients with severe renal disease.

No initial dose adjustment is necessary in patients with mild to moderate hepatic impairment. If you have any liver or kidney disease, more frequent blood potassium measurements may be required (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 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 medication 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 tablet at the scheduled time.

Otherwise, take the tablet as soon as you remember, provided that more than 12 hours remain before the next dose is due. Resume your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Eplerenone MABO

It is important to continue taking eplerenone as directed, unless your doctor advises you to stop treatment.

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:

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

• elevated blood potassium levels (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 heartbeats 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
• increased levels of creatinine 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)
• dehydration
• elevated levels of triglycerides (fats) in blood
• low sodium levels 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 levels
• 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 Medicines: https://www.notificaram.es. By reporting adverse 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 refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone MABO

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

Appearance of the product and contents of the pack:

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

Eplerenone MABO is available in blister packs of 30 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

The Netherlands

Date of the most recent revision of this leaflet: February 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/