Eplerenone Tarbis Farma 25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Eplerenone Tarbis Farma 25 mg film-coated tablets EFG

Eplerenone Tarbis Farma 50 mg film-coated tablets EFG

Please read all of this leaflet carefully before you start taking this medicine, as 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 other people, even if they have the same symptoms as you, because it may 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 Eplerenone Tarbis Farma is and what it is used for
2. What you need to know before taking Eplerenone Tarbis Farma
3. How to take Eplerenone Tarbis Farma
4. Possible adverse effects
5. How to store Eplerenone Tarbis Farma
6. Contents of the pack and other information

1. What Eplerenona Tarbis Farma 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 may cause changes in the body that lead to heart failure.

Eplerenone is used to treat heart failure to prevent worsening 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 ongoing treatment received up to now.

2. What you need to know before taking Eplerenona Tarbis Farma

Do not take Eplerenona Tarbis Farma

• 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 (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 itraconazole)
• if you are taking medicines used to treat HIV infection (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 taking, at the same time, medicines used to treat certain heart conditions 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 starting eplerenone.

• if you have kidney or liver disease (see also “Do not take Eplerenona Tarbis Farma”)
• 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 has not been established.

Taking Eplerenona Tarbis Farma 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 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 (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 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. 3 of 7
• 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 Eplerenona Tarbis Farma.
• Digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with Eplerenona Tarbis Farma.
• Warfarin (an anticoagulant medicine): Caution is required when administering warfarin doses, as high levels of warfarin in the blood may cause changes in the effect of Eplerenona Tarbis Farma 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) may reduce the metabolism of eplerenone, thereby prolonging its effect in the body.
• Hypericum perforatum (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 Eplerenona Tarbis Farma with food and drink

Eplerenona Tarbis Farma 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 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

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

Eplerenona Tarbis Farma contains lactose

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

Eplerenona Tarbis Farma contains sodium

Eplerenona Tarbis Farma contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Eplerenona Tarbis Farma

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

Eplerenona Tarbis Farma 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, 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 Tarbis Farma, 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 on alternate days. These doses may be adjusted, as directed by your doctor, according to your blood potassium levels.

Eplerenone 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, you may require more frequent blood potassium monitoring (see also "Do not take Eplerenona Tarbis Farma").

In elderly patients: no initial dose adjustment is required.

In children and adolescents: Eplerenona Tarbis Farma is not recommended.

If you take more Eplerenona Tarbis Farma than you should

If you take more Eplerenona Tarbis Farma 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, acute 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 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Eplerenona Tarbis Farma

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 Tarbis Farma

It is important to continue taking Eplerenona Tarbis Farma 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 will experience 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)
• headache
• heart problems, for example, 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 levels of creatinine 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 blood triglyceride levels (fats)
• 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 gland
• increased blood glucose
• reduced sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in certain blood tests

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Tarbis Farma

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

This medicine does not require any special storage conditions.

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

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. 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 Tarbis Farma

The active substance is eplerenone.

Each Eplerenona Tarbis 25mg film-coated tablet contains 25 mg of eplerenone.

Each Eplerenona Tarbis 50mg film-coated tablet contains 50 mg of eplerenone.

The other ingredients are:

Core: Lactose monohydrate, microcrystalline cellulose (E460), sodium lauryl sulfate, sodium croscarmellose (E468), hypromellose (E464), talc (E553b) and magnesium stearate (E470b).

Coating: Hypromellose (E464), titanium dioxide (E171), macrogol (E1521), polysorbate 80 (E433), yellow iron oxide (E172) and red iron oxide (E172).

Appearance of Eplerenona Tarbis Farma and contents of the pack

Film-coated tablets.

Eplerenona Tarbis Farma 25 mg film-coated tablets EFG

Film-coated, round, biconvex tablets, light yellow in colour, approximately 6.0 mm in diameter and 3.0 mm thick, engraved with a "V" on one side and "68" on the other side.

Eplerenona Tarbis Farma 50 mg film-coated tablets EFG

Film-coated, round, biconvex tablets, light yellow in colour, approximately 8.0 mm in diameter and 3.5 mm thick, engraved with a "V" on one side and "67" on the other side.

Eplerenona Tarbis Farma 25 mg and 50 mg film-coated tablets are available in opaque white PVC/Al blisters containing 20, 30, 50, 90, 100 or 250 tablets.

HDPE bottles: 30 and 90 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Germany: Eplerenone Amarox 25 mg/50 mg Filmtabletten

Spain: Eplerenona Tarbis Farma 25 mg/50 mg comprimidos recubiertos con película EFG

The Netherlands: Eplerenon Amarox 25 mg/50 mg, filmomhulde tabletten

Date of the most recent review of this leaflet:

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