EPLERENONE PENSA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eplerenonethinks25 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet

1. What is Eplerenone and what is it used for
2. What you need to know before taking Eplerenone
3. How to take Eplerenone
4. Possible side effects
5. Storage of Eplerenone
6. Package Contents and Additional Information

1. What is Eplerenone and what is it used for

Eplerenone 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 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

1. mild persistent symptoms, despite the treatment you have been receiving so far.

2. What you need to know before taking Eplerenone

Do not take Eplerenone

• If you are hypersensitive (allergic) to eplerenone or any of the other components of Eplerenone.
• If you have high levels of potassium in your blood (hyperkalemia).
• If you are taking medications from groups that help eliminate excess fluid in the body (potassium-sparing diuretics) or "salt tablets" (potassium supplements).
• If you have severe kidney failure.
• If you have severe liver failure.
• If you are taking medications used to treat fungal infections (ketoconazole or itraconazole).
• If you are taking antiviral medications for HIV treatment (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 medications 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 or pharmacist before starting to take eplerenone:

• If you have kidney or liver disease (see "Do not take Eplerenone").
• If you are taking lithium (used to treat manic-depressive disorders, also called bipolar disorder).
• If you are taking tacrolimus or cyclosporine (used to treat skin diseases such as psoriasis or eczema and to prevent organ rejection after transplantation).

Use of Eplerenone with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Eplerenone may affect other medications. These, in turn, may affect the proper functioning of eplerenone.

Do not take Eplerenone with the following medications (see section "Do not use Eplerenone"):

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medications for HIV treatment), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medications reduce the metabolism of Eplerenone, and thus prolong its effect in the body.

• Potassium-sparing diuretics (medications that help eliminate excess fluid in the body) or potassium supplements (salt tablets), as these medications increase the risk of high levels of potassium in the 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 medications may increase the risk of high levels of potassium in the blood.

Tell your doctor if you are taking any of the following medications:

• Lithium (used to treat manic-depressive disorders, 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 adverse reactions such as loss of appetite, vision changes, fatigue, muscle weakness, and muscle cramps.
• Cyclosporine or tacrolimus (used to treat skin diseases such as psoriasis or eczema and to prevent organ rejection after transplantation). These medications can cause kidney problems and thus increase the risk of high levels of potassium in the blood.
• Non-steroidal anti-inflammatory medications (NSAIDs - certain pain relievers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medications can cause kidney problems and thus increase the risk of high levels of potassium in the blood.
• Trimethoprim (used to treat bacterial infections) may increase the risk of high levels of potassium in the 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 medications 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 (used primarily 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 medication): Caution is required when taking warfarin, 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 medication for HIV treatment), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for the treatment of heart problems and high blood pressure) 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 other things, to treat epilepsy) may increase the metabolism of Eplerenone and thus reduce its effect.

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

Taking Eplerenone with food and drinks

Eplerenone can be taken with or without food.

Pregnancy and breastfeeding

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

It is not known whether eplerenone is excreted in breast milk. The doctor will decide with you whether to interrupt breastfeeding or suspend treatment.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

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

Eplerenone contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Eplerenone

Follow the administration instructions of Eplerenone exactly as indicated by your doctor. Consult your doctor or pharmacist again if you have doubts.

The tablets of Eplerenone should be swallowed whole with or without food. Swallow the tablets whole with plenty of water.

Eplerenone is usually administered along with other medications 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 levels in the blood should be measured before starting treatment with Eplerenone, during the first week, and one month after starting treatment or after a dose change. 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 according to your blood potassium levels. Eplerenone is not recommended in patients with severe kidney disease.

No initial dose adjustment is necessary in patients with mild to moderate liver failure. If you have liver or kidney problems, it may be necessary to perform potassium blood tests more frequently (see also "Do not take Eplerenone").

In the elderly: no initial dose adjustment is required.

In children and adolescents: Eplerenone is not recommended.

If you take more Eplerenone 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, 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 medication and the amount ingested.

If you forget to take Eplerenone

If it is almost time to take the next tablet, skip the missed dose and take the next tablet at the corresponding time. Otherwise, take the tablet as soon as you remember, provided that there are more than 12 hours until the time of taking the next tablet. Resume taking your medication as usual. Do not take a double dose to make up for missed doses.

If you stop treatment with Eplerenone

It is important to continue taking Eplerenone as indicated, unless your doctor tells you to stop treatment. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Eplerenone can have side effects, although not everyone experiences them.

If any of the following occur:

Seek medical attention immediately

• swelling of the face, tongue, or throat
• difficulty swallowing
• blisters and difficulty breathing

These are symptoms of angioedema.

Other reported side effects include:

Common side effects(occur in 1 to 10 out of 100 patients):

• myocardial infarction
• high levels of potassium in the blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• dizziness
• fainting
• infection
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• abnormal kidney function
• rash
• itching
• muscle spasms and pain
• increased levels of urea in the blood

Uncommon side effects(occur in 1 to 10 out of 1,000 patients):

• eosinophilia (increase in certain white blood cells)
• dehydration
• high levels of cholesterol or triglycerides (fats) in the blood
• low levels of sodium in the blood
• insomnia (difficulty sleeping)
• headache
• heart problems such as irregular heartbeat, rapid heartbeat, and heart failure
• inflammation of the gallbladder
• low blood pressure that can cause dizziness when standing up
• blood clots in the legs
• sore throat
• flatulence
• vomiting
• underactive thyroid
• increased blood glucose
• decreased sense of touch
• increased sweating
• back pain
• weakness and general malaise
• elevated creatinine levels in the blood, which may indicate kidney problems
• kidney inflammation
• breast enlargement in men
• changes in certain blood tests.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Eplerenone

Keep this medication out of the sight and reach of children.

Do not use Eplerenone after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Eplerenone

• The active ingredient is eplerenone. Each tablet contains 25 mg of eplerenone.
• The other ingredients are lactose monohydrate, microcrystalline cellulose (type 101), sodium croscarmellose, hypromellose (Type 2910), microcrystalline cellulose (Type 102), sodium lauryl sulfate, talc, magnesium stearate (core of the tablet);

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

Appearance of the product and package contents

25 mg tablet: film-coated tablets, white to almost white, round, biconvex, marked "CG3" on one face of the tablet and smooth (unmarked) on the other face.

Eplerenone 25 mg film-coated tablets EFG are available in blister packs of 30 and 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Liconsa S.A.

Avenida Miralcampo 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Date of the last revision of this package leaflet:August 2012

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/