Eplerenone Aurovitas Spain 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eplerenone Aurovitas Spain 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.

• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Eplerenona Aurovitas Spain is and what it is used for

Eplerenone 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.

Eplerenone is used to treat heart failure to prevent its worsening and to reduce hospitalization in patients who have:

• recently had a myocardial infarction, in combination with other medicines used to treat heart failure, or
• persistent mild symptoms, despite ongoing treatment received up to now.

2. What you need to know before taking Eplerenone Aurovitas Spain

Do not take Eplerenone Aurovitas Spain

• 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 get rid of 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 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 disorders or hypertension (such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists (ARA)).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Eplerenone Aurovitas Spain:

• if you have kidney or liver disease (see also “Do not take Eplerenone Aurovitas Spain”).
• if you are taking lithium (commonly used for manic-depressive disorder, also known as bipolar disorder).
• if you are taking tacrolimus or cyclosporine (used to treat skin diseases 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 has not been established.

Taking Eplerenone Aurovitas Spain with other medicines

Tell 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 HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the metabolism of eplerenone, thereby prolonging its effect in the body.

• Potassium-sparing diuretics (medicines that help your body eliminate excess fluid, such as spironolactone, amiloride and triamterene) and potassium supplements (salt tablets), as these medicines increase the risk of developing high potassium levels in your blood.

• Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists (ARA) 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.

• Lithium (commonly used for manic-depressive disorder, also known as 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 effects: loss of appetite; vision disturbances; fatigue; muscle weakness; muscle cramps.

• Cyclosporine or tacrolimus (used to treat skin diseases 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 your 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 your blood.

• Trimethoprim (used to treat bacterial infections) may increase the risk of high potassium levels in your 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 (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 drop in blood pressure and dizziness upon standing.

• Glucocorticoids (such as hydrocortisone or prednisone) (used to treat inflammation and certain skin diseases) and tetracosactide (mainly used 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 taking warfarin, as high levels of warfarin in the blood may affect the action of eplerenone in the body.

• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for the treatment of HIV), 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, thereby prolonging its effect in the body.

• 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 and thus reduce its effect.

Taking Eplerenone Aurovitas Spain with food and drink

Eplerenone may 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 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 breastfeeding should be discontinued or treatment stopped.

Driving and using machines

You may feel dizzy after taking eplerenone. If this occurs, do not drive or operate machinery.

Eplerenone Aurovitas Spain contains lactose monohydrate

This medicine contains lactose monohydrate (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Eplerenone Aurovitas Spain contains sodium

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

3. How to take Eplerenone Aurovitas Spain

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

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

Eplerenone is usually administered together with other medications for heart failure, e.g., beta-blockers. The recommended starting dose is one 25 mg tablet once daily, increasing after approximately 4 weeks to 50 mg daily (by taking one 50 mg tablet or two 25 mg tablets). The maximum dose is 50 mg daily.

Blood potassium levels should be measured before starting treatment with eplerenone, 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. This is especially important if you are elderly or have kidney disease or diabetes, as you are at higher risk of having high 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 tablets are not recommended for patients with severe renal impairment.

No initial dose adjustment is necessary in patients with mild to moderate hepatic impairment. If you have liver or kidney problems, more frequent monitoring of blood potassium levels may be required (see also “Do not take Eplerenone Aurovitas Spain”).

In elderly patients: no adjustment of the initial dose is required.

Use in children and adolescents

In children and adolescents: eplerenone is not recommended.

If you take more Eplerenone Aurovitas Spain than you should

If you take more eplerenone than you should, inform your doctor or pharmacist immediately. If you have taken too much medication, 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 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Eplerenone Aurovitas Spain

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 missed 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 Aurovitas Spain

It is important to continue taking eplerenone as prescribed, 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 will experience 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, an uncommon adverse effect (may affect 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 (symptoms include muscle cramps, diarrhea, nausea, dizziness or headache)
• dizziness
• fainting
• elevated cholesterol levels in the blood
• difficulty sleeping (insomnia)
• headache
• heart problems, such as irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• spasms
• increased blood urea levels
• elevated blood creatinine levels, which may indicate kidney problems

Uncommon adverse effects: may affect up to 1 in 100 people

• infection
• increase in certain white blood cells (eosinophilia)
• dehydration
• elevated triglyceride (fat) levels in the blood
• low blood sodium levels
• rapid heartbeat
• inflammation of the gallbladder
• low blood pressure that may cause dizziness upon standing
• thrombosis (blood clot) in the leg
• sore throat
• flatulence
• hypothyroidism
• increased blood sugar levels
• decreased sense of touch
• increased sweating
• general malaise
• musculoskeletal pain
• kidney inflammation
• breast enlargement in men
• changes in certain blood test results

Reporting of adverse effects

If you experience any adverse effects, consult 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: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Aurovitas Spain

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, 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 Eplerenona Aurovitas Spain

• The active substance is eplerenone. Each tablet contains 50 mg of eplerenone.
• The other components are monohydrate lactose, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), sodium lauryl sulfate, talc (E553b), magnesium stearate (tablet core); hypromellose (E464), polysorbate 80 (E433), macrogol 400, titanium dioxide (E171), yellow iron oxide (E172) (tablet coating).

Appearance of the product and contents of the pack

Light yellow, round, biconvex, film-coated tablet with a diameter of approximately 8 mm. The tablet is marked with “E9RN” on one side and “50” on the other.

Eplerenona Aurovitas Spain is available in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 or 100 tablets; unit-dose blister packs of 10 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, or 100 x 1 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Generis Farmacêutica, S.A.

Rua Joao de Deus, nº 19, Venda Nova,

2700-487 Amadora

Portugal

Or

APL swift Services (Malta) Ltd.

HF26 Hal Far Industrial Estate, Hal Far,

Birzebbugia BBG 3000

Malta

Date of the most recent revision of this leaflet: June 2022

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