Eplerenone Normon 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eplerenona Normon 50 mg film-coated tablets EFG

Eplerenone

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 you must not give it to others, 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Eplerenona 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 that regulates blood pressure and heart function. Elevated levels of aldosterone can cause changes in the body that may lead to heart failure.

Eplerenona Normon 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 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 from groups that help your body eliminate excess fluid (potassium-sparing diuretics) or "salt tablets" (potassium supplements).
• If you have severe renal impairment.
• If you have severe hepatic impairment.
• 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 for depression.
• If you are simultaneously taking medicines used to treat certain heart conditions or hypertension (such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists (ARBs)).

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 (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 Normon with other medicines

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

You must not take Eplerenone Normon with the following medicines (see section "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, 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 (ACE) inhibitors and angiotensin receptor antagonists (ARBs), which are used simultaneously 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.

Tell 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 lead to 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), which 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), which may reduce the blood pressure-lowering effect of Eplerenone Normon.
• Digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with Eplerenone Normon.
• Warfarin (an anticoagulant medicine). Caution is required when administering warfarin doses, as elevated warfarin levels in the blood may be influenced by changes caused by 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, thereby prolonging its effect in the body.
• Hypericum perforatum or St. John's wort (a herbal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy), which may increase the metabolism of Eplerenone Normon and thus reduce its effect.

Taking Eplerenone Normon with food, drinks, and alcohol

Eplerenone Normon may be taken with or without food.

Pregnancy, breastfeeding, and fertility

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.

The effect of Eplerenone Normon 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 Normon, you may feel dizzy. If this occurs, do not drive or operate machinery.

Eplerenone Normon contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him 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 Eplerenona Normon

Follow exactly the instructions for administering Eplerenona Normon given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Eplerenona Normon 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 Normon, 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.

Eplerenona Normon 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 any liver or kidney disease, your blood potassium levels may need to be monitored more frequently (see also "Do not take Eplerenona Normon").

In elderly patients: no initial dose adjustment is required.

In children and adolescents: Eplerenona Normon is not recommended.

If you take more Eplerenona Normon than you should

If you take more Eplerenona Normon than you should, inform your doctor or pharmacist immediately. If you have taken an excessive amount of the medicine, the most likely symptoms are low blood pressure (manifested as dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalaemia (high levels of potassium in the blood), manifested by 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 Eplerenona Normon

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 Eplerenona Normon

It is important to continue taking Eplerenona Normon 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, Eplerenona Normon can have adverse effects, although not everyone experiences them.

If you experience any of the following, seek immediate medical attention:

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

These are symptoms of angioneurotic edema.

Other reported adverse effects include:

Frequent adverse effects (occur in 1 to 10 out of every 100 patients):

• myocardial infarction

• elevated potassium levels in blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)

• dizziness

• fainting

• elevated cholesterol levels in blood

• headache

• insomnia (difficulty sleeping)

• cardiac discomfort, for example, irregular heartbeats

• cough

• constipation

• low blood pressure

• diarrhea

• nausea

• vomiting

• abnormal kidney function

• rash

• itching

• back pain

• muscle spasm

• increased blood urea levels

• increased blood creatinine levels, which may indicate kidney problems.

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

• infection

• eosinophilia (increase in certain white blood cells)

• dehydration

• elevated levels of cholesterol or triglycerides (fats) in blood

• low sodium levels 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

• vomiting

• underactive thyroid

• increased blood glucose

• 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 ºC.

Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help 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 components (excipients) are:

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

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

Appearance of the product and contents of the pack

Eplerenone Normon 50 mg is presented as film-coated tablets. The tablets are cream-colored, round, biconvex, and printed with "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 summary of product characteristics was approved in June 2015

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.

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