Eplerenone Combix 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Eplerenona Combix 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Contents of the leaflet

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

1. What Eplerenona Combix is and what it is used for

Eplerenona Combix 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 your body that may lead to heart failure.

Eplerenona Combix 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. Persistent mild symptoms, despite the treatment you have been receiving up to now.

2. What you need to know before taking Eplerenone Combix

Do not take Eplerenone Combix

• If you are hypersensitive (allergic) to eplerenone or to any of the other components of Eplerenone Combix
• If you have high levels of potassium in the blood (hyperkalaemia).
• If you are taking medicines from groups that help eliminate excess fluid from the body (potassium-sparing diuretics) or "salt tablets" (potassium supplements).
• If you have severe renal insufficiency.
• If you have severe hepatic insufficiency.
• If you are taking antifungal 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 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

Consult your doctor or pharmacist before starting eplerenone:

• If you have kidney or liver disease (see “Do not take Eplerenone Combix”)
• If you are taking lithium (commonly used for manic-depressive disorders, also called bipolar disorder)
• If you are taking tacrolimus or cyclosporine (used to treat skin conditions such as psoriasis or eczema and to prevent rejection of transplanted organs)

Use of Eplerenone Combix with other medicines

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

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

You must not take Eplerenone Combix with the following medicines (see section “Do not use Eplerenone Combix”):

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for treating AIDS), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the metabolism of Eplerenone Combix, thereby prolonging its effect in the body.

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

• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARBs) taken simultaneously (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.

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

• Lithium (commonly used for manic-depressive disorders, 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 cause the following adverse reactions: loss of appetite, vision disturbances, fatigue, muscle weakness, and muscle cramps.
• Cyclosporine or tacrolimus (used to treat skin conditions 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 the blood.
• Trimethoprim (used to treat bacterial infections) may increase the risk of high potassium levels in the 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 the treatment of depression), antipsychotics (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 drop in blood pressure and dizziness upon standing.
• Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions), and tetracosactide (used mainly to diagnose and treat adrenal cortex disorders), may reduce the blood pressure-lowering effect of Eplerenone Combix.
• Digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with Eplerenone Combix.
• Warfarin (an anticoagulant medicine): Caution is required when taking warfarin, as high levels of warfarin in the blood may cause changes in the effect of Eplerenone Combix 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) reduce the metabolism of Eplerenone Combix, 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 Combix and thus reduce its effect.

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

Taking Eplerenone Combix with food and drink

Eplerenone Combix may be taken with or without food.

Pregnancy and breastfeeding

The effect of Eplerenone Combix 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 breastfeeding or to stop 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 medicine.

Driving and use of machines

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

Eplerenone Combix contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Eplerenona Combix

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

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

Eplerenona Combix is usually administered together with other medications for heart failure, for example, beta-blockers. The usual initial 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 Eplerenona Combix, 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 on alternate days. These doses may be adjusted, as directed by your doctor, according to your blood potassium levels.

Eplerenona Combix is not recommended in patients with severe renal disease.

No initial dose adjustment is required in patients with mild to moderate hepatic impairment. 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 Combix”).

In elderly patients: no initial dose adjustment is required.

In children and adolescents: Eplerenona Combix is not recommended.

If you take more Eplerenona Combix than you should

If you take more Eplerenona Combix 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, 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, 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 Eplerenona Combix

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 time for taking the next tablet. Then continue taking your medicine as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Eplerenona Combix

It is important to continue taking Eplerenona Combix 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, Eplerenone Combix can have adverse effects, although not everyone gets them.

If any of the following occur:

Seek immediate medical attention

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

These are symptoms of angioedema.

Other reported adverse effects include:

Common adverse effects (occur in between 1 and 10 out 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 spasm and muscle pain
• Increased levels of urea in the blood

Uncommon adverse effects (occur in between 1 and 10 out of every 1,000 patients):

• Eosinophilia (increase in certain white blood cells)
• Dehydration
• Elevated levels of cholesterol or triglycerides (fats) in the blood
• Low levels of sodium in the blood
• Insomnia (difficulty sleeping)
• Headache
• Heart-related discomfort such as irregular heartbeat, rapid heartbeat, or heart failure
• Inflammation of the gallbladder
• Drop in blood pressure that may cause dizziness upon standing
• Thrombosis (blood clot) in the legs
• Sore throat
• Flatulence
• Vomiting
• Underactive thyroid
• Increased blood glucose
• Reduced sense of touch
• Increased sweating
• Back pain
• Weakness and general malaise
• Elevated levels of creatinine in the blood, which may indicate kidney problems
• Kidney inflammation
• Breast enlargement in men
• Changes in certain blood test results

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

5. Storage of Eplerenone Combix

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

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, 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 Combix

• The active substance is eplerenone. Each tablet contains 50 mg of eplerenone.
• The other components are monohydrate lactose, 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: monohydrate lactose, hypromellose (type 2910), titanium dioxide (E171), macrogol 4000 (tablet coating).

Appearance of the product and contents of the container

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcon (Madrid)

Manufacturer:

Laboratorios LICONSA S.A.

Avenida Miralcampo 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Date of the most recent revision of this leaflet: August 2012

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