EPLERENONE NORMON 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eplerenone Normon 50 mg Film-Coated Tablets EFG

Eplerenone

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. See section 4.

Contents of the pack

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

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

Eplerenone Normon belongs to a group of medicines known as selective aldosterone blockers. These blockers inhibit the action of aldosterone, a substance produced by the body, which controls blood pressure and cardiac function. High levels of aldosterone can cause changes in your body that lead to heart failure.

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

2. What you need to know before you take Eplerenone Normon

Do not take Eplerenone Normon

• If you are allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6).
• If you have high levels of potassium in your blood (hyperkalemia).
• If you are taking medicines that help your body get rid of excess fluid (potassium-sparing diuretics) or 'salt tablets' (potassium supplements).
• If you have severe kidney problems.
• If you have severe liver problems.
• If you are taking medicines used to treat fungal infections (ketoconazole or itraconazole).
• 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 to treat 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 Normon:

• If you have kidney or liver disease (see "Do not take eplerenone Normon").
• If you are taking lithium (usually used for 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 rejection after transplants).

Children and adolescents

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

Taking Eplerenone Normon with other medicines

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

Do not take Eplerenone Normon with the following medicines (see "Do not take Eplerenone Normon"):

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for treating HIV), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression), as these medicines reduce the metabolism of Eplerenone Normon, and thus prolong its effect in the body.
• • Potassium-sparing diuretics (medicines that help your body get rid of excess fluid) 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.

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

• Lithium (usually used for 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 changes, fatigue, muscle weakness, and muscle cramps.
• Cyclosporin or tacrolimus (used to treat skin diseases such as psoriasis or eczema and to prevent organ rejection after transplants). 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 Normon.
• Digoxin (used in the treatment of heart diseases). Blood levels of digoxin may increase when taken with Eplerenone Normon.
• Warfarin (an anticoagulant medicine). Caution is required when administering warfarin doses, as high levels of warfarin in the blood may cause changes in Eplerenone Normon 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), as they reduce the metabolism of Eplerenone Normon, thus prolonging the effect of Eplerenone Normon in the body.
• Hypericum perforatumor St. John's Wort (a herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among other things, to treat epilepsy), may increase the metabolism of Eplerenone Normon and thus reduce its effect.

Taking Eplerenone Normon with food, drinks, and alcohol

Eplerenone Normon can be taken with or without food.

Pregnancy, breast-feeding, and fertility

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.

The effect of Eplerenone Normon 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 discontinue treatment or breast-feeding.

Driving and using machines

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

Eplerenone Normon contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Eplerenone Normon

Follow exactly the administration instructions of Eplerenone Normon given by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Eplerenone Normon 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 blood levels should be determined before starting treatment with Eplerenone Normon, during the first week, and one month after starting treatment or after a change in dose. Your doctor may adjust the dose based on your potassium blood levels.

If you have mild kidney problems, you should start treatment with a 25 mg tablet per day, and if you have moderate kidney problems, you should start treatment with a 25 mg tablet every other day. These doses may be adjusted, if your doctor indicates, and according to your potassium blood levels.

Eplerenone Normon is not recommended in patients with severe kidney disease.

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

In the elderly: no initial dose adjustment is required.

In children and adolescents: Eplerenone Normon is not recommended.

If you take more Eplerenone Normon than you should

If you take more Eplerenone Normon than you should, contact 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 ingested.

If you forget to take Eplerenone Normon

If it is almost time for your next dose, skip the dose you missed and take the next tablet at the right time. Otherwise, take the tablet as soon as you remember, provided that more than 12 hours have passed since the time you should have taken the last tablet. Take your medicine as usual.

Do not take a double dose to make up for forgotten doses.

If you stop taking Eplerenone Normon

It is important to keep taking Eplerenone Normon 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 Normon can cause side effects, although not everybody gets them.

If you experience any of the following, 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

• high levels of cholesterol in the blood
• headache
• insomnia (difficulty sleeping)
• heart problems, such as irregular heartbeats

• cough
• constipation
• low blood pressure
• diarrhea
• nausea

• vomiting

• abnormal kidney function
• rash
• itching
• back pain
• muscle spasms
• increased levels of urea in the blood
• increased levels of creatinine in the blood, which may indicate kidney problems.

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

• infection

• eosinophilia (an increase in certain white blood cells)
• dehydration
• high levels of cholesterol or triglycerides (fats) in the blood
• low levels of sodium in the blood

• rapid heartbeat

• inflammation of the gallbladder
• low blood pressure that may cause dizziness when standing up
• blood clots in the legs
• sore throat
• flatulence
• vomiting
• underactive thyroid
• increased blood sugar levels
• decreased sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in certain blood tests.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Normon

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

Store below 30°C.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone Normon

The active substance is eplerenone. Each tablet contains 50 mg of eplerenone.

The other ingredients (excipients) are:

Core:Microcrystalline cellulose, lactose, sodium croscarmellose, sodium lauryl sulfate, hydroxypropyl methylcellulose, colloidal silicon dioxide, and magnesium stearate.

Coating:Hypromellose, titanium dioxide (E-171), talc, macrogol 6000, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Eplerenone Normon 50 mg is presented in the form of film-coated tablets. They are cream-colored, round, biconvex tablets with serigraphy "50". Each pack contains 30 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Eplerenone Normon 25 mg film-coated tablets EFG

This leaflet was approved in June 2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) www.aemps.gob.es

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone.

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75988/P_75988.html.