Package Insert: Information for the Patient

Eplerenone50 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 only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

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

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

3. How to take Eplerenone Pensa

4. Possible adverse effects

5. Storage of Eplerenone Pensa

6. Contents of the package and additional information

EplerenonaPensabelongs 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 lead to heart failure.

EplerenonaPensais 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 up to this point.

Do not take EplerenonaThink

• If you are hypersensitive (allergic) to eplerenona or to any of the other components of EplerenonaThink.
• If you have high levels of potassium in your blood (hyperkalemia).
• If you are taking medications that help eliminate excess fluids in the body (potassium-sparing diuretics) or "salt tablets" (potassium supplements).
• If you have severe kidney disease.
• If you have severe liver disease.
• 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 or high blood pressure conditions (such as ACE inhibitors and ARAs) at the same time.

Warnings and precautions

Consult your doctor or pharmacist before starting to take eplerenona:

• If you have kidney or liver disease (see "Do not take EplerenonaThink”).
• If you are taking lithium (usually used to treat manic-depressive disorders, 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 EplerenonaThinkwith other medications

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

Eplerenona may affect other medications. These, in turn, may affect the proper functioning of eplerenona.

Do not take EplerenonaThinkwith the following medications (see section "Do not use EplerenonaThink”):

• 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 ofEplerenonaThink, and therefore prolong its effect in the body.

• Potassium-sparing diuretics (medications that help eliminate excess fluids in the body) or potassium supplements (salt tablets), as these medications increase the risk of high potassium levels in your blood.
• ACE inhibitors and ARAs (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.

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

• Lithium (usually used to treat manic-depressive disorders, 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 high lithium levels in the blood that may cause the following adverse reactions: loss of appetite, vision changes, fatigue, muscle weakness, and muscle cramps.
• Cyclosporine or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent organ transplant rejection). These medications may cause kidney problems and therefore increase the risk of high potassium levels in your blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - certain analgesics such as ibuprofen (used to relieve pain, stiffness, and inflammation). These medications may cause kidney problems and therefore 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 cause a decrease in blood pressure and dizziness when standing up.
• Tricyclic antidepressants such as amitriptyline or amoxapine (used to treat depression), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (used to treat psychiatric disorders), amifostine (used during cancer chemotherapy), and baclofen (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) and tetracosactide (used primarily to diagnose and treat adrenal gland disorders) may reduce the blood pressure-lowering effect ofEplerenonaThink.
• Digoxin (used to treat heart conditions). Digoxin blood levels may increase when taken withEplerenonaThink.
• Warfarin (an anticoagulant medication): Caution is required when taking warfarin because high warfarin levels in the blood may cause changes in the effect ofEplerenonaThinkin 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 (used to treat heart conditions and high blood pressure) reduce the metabolism ofEplerenonaThink, prolonging its effect in the body.
• St. John's Wort (Hypericum perforatum), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy) may increase the metabolism ofEplerenonaThinkand therefore reduce its effect.

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

Taking EplerenonaThinkwith food and drinks

EplerenonaThinkcan be taken with or without food.

Pregnancy and breastfeeding

The effect ofEplerenonaon humans during pregnancy has not been evaluated.Eplerenonais unknown whether eplerenona is excreted in breast milk. Your doctor will decide with you whether to stop breastfeeding or suspend treatment.

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

Driving and operating machinery

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

EplerenonaThinkcontains lactose

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

Follow exactly the administration instructions for Eplerenona as indicated by your doctor. Consult your doctor or pharmacist again if you have any doubts.

The Eplerenona Pensa tablets can be taken with or without food. Swallow the tablets whole with plenty of water.

Eplerenona Pensa is usually taken together with other medications for heart failure, such as 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.

It is necessary to measure blood potassium levels before starting treatment with Eplerenona Pensa, 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 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 blood potassium levels.

Eplerenona Pensa is not recommended for patients with severe kidney disease.

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

In the elderly: no initial dose adjustment is required.

In children and adolescents: Eplerenona Pensa is not recommended.

If you take more Eplerenona Pensa than you should

If you take more Eplerenona Pensa 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Eplerenona Pensa

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, as long as more than 12 hours have passed since the usual time for taking the next tablet. Then, resume your medication as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eplerenona Pensa

It is essential to continue taking Eplerenona Pensa 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,EplerenonaPensamay 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.

Other side effects reported include:

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

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

Rare side effects(occur in 1 to 10 of every 1,000 patients):

• increased levels of certain white blood cells (eosinophilia)
• dehydration
• high levels of cholesterol or triglycerides (fats) in the blood
• low levels of sodium in the blood
• difficulty sleeping (insomnia)
• headache
• cardiac symptoms such as irregular heartbeat, myocardial infarction, and heart failure
• inflammation of the gallbladder
• low blood pressure that can cause dizziness when standing
• thrombosis (blood clot) in the legs
• sore throat
• flatulence
• vomiting
• hypothyroidism
• increased blood glucose
• decreased sense of touch
• increased sweating
• back pain
• weakness and general malaise
• increased levels of creatinine in the blood that may indicate kidney problems
• inflammation of the kidney
• gynecomastia 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 prospectus.

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

Do not useEplerenonaPensaafter 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.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Eplerenone CompositionPensa

• The active ingredient is eplerenone. Each tablet contains 50 mg of eplerenone.
• The other components 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 contents of the packaging

50 mg tablet: white to off-white coated tablets, round, biconvex, marked “CG4” on one face of the tablet and smooth (unmarked) on the other face.

EplerenonePensa50 mg coated tablets are available in blister packs of 30 and 50 tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible Manufacturer:

Laboratorios Liconsa S.A.

Avenida Miralcampo 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Last review date of this leaflet:August 2012

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