Eplerenone Alter 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eplerenone Alter 25 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, 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. Do not give it to others, even if they have the same symptoms as you, because it may 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.

Contents of the leaflet

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

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

Eplerenona Alter 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.

Eplerenona Alter is used to treat heart failure to prevent worsening of the condition and reduce hospitalization in patients who have:

1. recently had 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 taking Eplerenone Alter

Do not take Eplerenone Alter

• 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 (hyperkalaemia)
• if you are taking medicines 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 itraconazol)
• if you are taking medicines used to treat HIV infections (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

Consult your doctor or pharmacist before starting Eplerenone Alter

• if you have kidney or liver disease (see also "Do not take Eplerenone Alter")
• 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)

Children and adolescents

The safety and efficacy of eplerenone in children and adolescents have not been established.

Taking Eplerenone Alter with other medicines

Inform 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 AIDS), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the metabolism of Eplerenone Alter, 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 levels of potassium in the blood.

• 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 lead to the following adverse reactions: loss of appetite, visual 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 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.

• 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 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 (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.

• 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 result from changes in eplerenone metabolism.

• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for treating HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart problems and high blood pressure) may reduce the metabolism of eplerenone, thereby prolonging its effect in the body.

• Hypericum perforatum (St. John's Wort, a 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 thereby reduce its effect.

Taking Eplerenone Alter with food and drinks

Eplerenone Alter can be taken with or without food.

Pregnancy and breastfeeding

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

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

Eplerenone Alter 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 Eplerenone Alter

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

Eplerenone Alter tablets may be taken with or without food. Swallow the tablets whole with plenty of water.

Eplerenone Alter 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, which is then increased 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 Alter, 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, treatment should be initiated 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 Alter 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 liver or kidney disease, you may require more frequent monitoring of blood potassium levels (see also "Do not take Eplerenone Alter").

In elderly patients: No initial dose adjustment is required.

In children and adolescents: Eplerenone Alter is not recommended.

If you take more Eplerenone Alter than you should

If you take more Eplerenone Alter than you should, inform your doctor or pharmacist immediately. If you have taken an overdose, the most likely symptoms are low blood pressure (manifested as dizziness, blurred vision, weakness, or sudden loss of consciousness) or hyperkalaemia (high potassium levels in the blood), which may present as 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 Alter

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 scheduled dose. Then continue taking your medicine as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Eplerenone Alter

It is important to continue taking Eplerenone Alter 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 experiences 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:

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

• elevated blood potassium levels (these symptoms include muscle cramps, diarrhea, nausea, dizziness or headache)
• fainting
• dizziness
• elevated blood cholesterol levels
• insomnia (difficulty sleeping)
• heart-related discomfort, such as irregular heartbeat 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
• elevated creatinine levels 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)
• low sodium levels in blood
• dehydration
• elevated levels of triglycerides (fats) 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 test results

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Alter

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

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

6. Contents of the pack and other information

Composition of Eplerenone Alter

• The active substance in this medicine is eplerenone. Each tablet contains 25 mg of eplerenone.

The other components are:

Tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, talc, magnesium stearate.

Tablet coating: hypromellose, Macrogol 400, Polysorbate 80 (E433), titanium dioxide, yellow iron oxide (E172) and red iron oxide (E172).

Appearance of Eplerenone Alter and contents of the pack

Eplerenone Alter 25 mg film-coated tablets are beige-colored, round and biconvex, with the imprint ''25'' on one side.

Eplerenone Alter 25 mg film-coated tablets are available in boxes with blisters containing 10, 20, 28, 30, 50, 90, 100 or 200 tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

Date of the most recent revision of this leaflet: February 2019

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