EPLERENONE KERN PHARMA 50 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Eplerenone Kern Pharma 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.

Contents of the pack

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

1. What Eplerenone Kern Pharma is and what it is used for

Eplerenone Kern Pharma 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 Kern Pharma 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

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

2. What you need to know before you take Eplerenone Kern Pharma

Do not take Eplerenone Kern Pharma

• If you are hypersensitive (allergic) to eplerenone or any of the other ingredients of Eplerenone Kern Pharma.
• If you have high levels of potassium in your blood (hyperkalemia).
• If you are taking medicines from groups that help eliminate excess fluid in the body (potassium-sparing diuretics) or "salt tablets" (potassium supplements).
• If you have severe kidney impairment.
• If you have severe liver impairment.
• If you are taking medicines used to treat fungal infections (ketoconazole or itraconazole).
• If you are taking antiviral medicines for the treatment of HIV (ritonavir or nelfinavir).
• If you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin).
• If you are taking nefazodone for the treatment of 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 or pharmacist before starting to take eplerenone:

• If you have kidney or liver disease (see "Do not take Eplerenone Kern Pharma")
• 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)

Use of Eplerenone Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

Do not take Eplerenone Kern Pharma with the following medicines (see section "Do not use Eplerenone Kern Pharma"):

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

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

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

• 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 the following adverse reactions: loss of appetite, vision disturbances, 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 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 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 Kern Pharma.
• Digoxin (used in the treatment of heart diseases). Blood levels of digoxin may increase when taken with Eplerenone Kern Pharma.
• Warfarin (an anticoagulant medicine): caution is required when taking warfarin because high levels of warfarin in the blood may cause changes in the effect of Eplerenone Kern Pharma in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for the treatment of HIV infections), 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 Kern Pharma, 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 Kern Pharma and thus reduce its effect.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Eplerenone Kern Pharma with food and drinks

Eplerenone Kern Pharma can be taken with or without food.

Pregnancy and breast-feeding

The effect of Eplerenone Kern Pharma 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 interrupt breast-feeding or to stop treatment.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Eplerenone Kern Pharma contains lactose

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

3. How to take Eplerenone Kern Pharma

Follow exactly the administration instructions of Eplerenone Kern Pharma given by your doctor. Consult your doctor or pharmacist again if you have any doubts.

The tablets of Eplerenone Kern Pharma can be taken with or without food. Swallow the tablets whole with plenty of water.

Eplerenone Kern Pharma is usually given together with other medicines for heart failure, for example, 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 Kern Pharma, during the first week, and after one month of starting treatment or after a change in dose. Your doctor may adjust the dose based on your potassium levels in the blood.

If you have mild kidney impairment, you should start treatment with one 25 mg tablet per day, and if you have moderate kidney impairment, 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 Kern Pharma is not recommended in patients with severe kidney disease.

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

In elderly patients: no initial dose adjustment is required.

In children and adolescents: Eplerenone Kern Pharma is not recommended.

If you take more Eplerenone Kern Pharma than you should

If you take more Eplerenone Kern Pharma 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Eplerenone Kern Pharma

If it is almost time for your next dose, skip the missed dose and take the next dose at the right time.

Otherwise, take the dose as soon as you remember, provided that more than 12 hours have passed since the time you should have taken the dose. Then, take your medicine as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Eplerenone Kern Pharma

It is important to keep taking Eplerenone Kern Pharma as your doctor has told you, unless your doctor tells you to stop. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Eplerenone Kern Pharma 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.

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 (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 of every 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 heartbeats, rapid heartbeats, 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 levels
• decreased sense of touch
• increased sweating
• back pain
• weakness and general malaise
• increased levels of creatinine in the blood, which may indicate kidney problems
• kidney inflammation
• breast enlargement in men
• changes in certain blood tests.

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet.

5. Storage of Eplerenone Kern Pharma

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

Do not use Eplerenone Kern Pharma after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone Kern Pharma

• The active substance is eplerenone. Each tablet contains 50 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 (tablet core);

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

Appearance and packaging

50 mg tablet: white or almost white, round, biconvex, film-coated tablets, marked "CG4" on one side of the tablet and smooth (unmarked) on the other side.

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

Marketing authorization holder and manufacturer

Marketing authorization holder:Kern Pharma, S.L.

Venus, 72. Poligono Industrial Colon II.

08228 Tarrasa, Barcelona

Manufacturer:

Laboratorios LICONSA S.A.

Avenida Miralcampo 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Date of last revision of this leaflet: August 2012

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/