EPLERENONE TARBIS FARMA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eplerenone Tarbis Farma 25 mg film-coated tablets EFG

Eplerenone Tarbis Farma 50 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, 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 Tarbis Farma and what is it used for
2. What you need to know before you take Eplerenone Tarbis Farma
3. How to take Eplerenone Tarbis Farma
4. Possible side effects
5. Storage of Eplerenone Tarbis Farma
6. Contents of the pack and other information

1. What is Eplerenone Tarbis Farma and what is it 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 controls blood pressure and cardiac function. High levels of aldosterone can produce changes in your body that lead to heart failure.

Eplerenone 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 Tarbis Farma

Do not take Eplerenone 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 (hyperkalemia)
• if you are taking medicines that help your body get rid of excess fluid (potassium-sparing diuretics)
• 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 infection (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 conditions or high blood pressure (such as ACE inhibitors and angiotensin receptor antagonists) at the same time.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take eplerenone.

• if you have kidney or liver disease (see also “Do not take Eplerenone Tarbis Farma”)
• if you are taking lithium (used to treat manic-depressive disorders, also known as bipolar disorder)
• if you are taking tacrolimus or cyclosporin (used to treat skin diseases such as psoriasis or eczema and to prevent organ transplant rejection)

Children and adolescents

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

Using Eplerenone Tarbis Farma with other medicines

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

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines used to treat HIV), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression), as these medicines reduce the metabolism of eplerenone, 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.
• Lithium (used to treat manic-depressive disorders, also known as 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 transplant rejection). 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 (used primarily to diagnose and treat adrenal cortex diseases), may reduce the blood pressure-lowering effect of Eplerenone Tarbis Farma.
• Digoxin (used in the treatment of heart diseases). Blood levels of digoxin may increase when taken with Eplerenone Tarbis Farma.
• Warfarin (an anticoagulant medicine): caution is required when administering warfarin doses, as high levels of warfarin in the blood may alter the effect of Eplerenone Tarbis Farma in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine used to treat 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, thus prolonging its effect in the body.
• Hypericum perforatum or St. John's Wort (a herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among other things, to treat epilepsy), may increase the metabolism of eplerenone and thus reduce its effect.

Taking Eplerenone Tarbis Farma with food and drinks

Eplerenone Tarbis Farma can be taken with or without food.

Pregnancy and breast-feeding

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 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 interrupt treatment or breast-feeding.

Driving and using machines

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

Eplerenone Tarbis Farma contains lactose

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

Eplerenone Tarbis Farma contains sodium

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

3. How to take Eplerenone Tarbis Farma

Follow exactly the instructions of your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

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

Eplerenone is usually given together with other medicines for heart failure, for example, beta-blockers. The usual initial dose is one 25 mg tablet once daily, 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 Tarbis Farma, 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 one 25 mg tablet per day, and if you have moderate kidney problems, you should start treatment with one 25 mg tablet every other day. These doses may be adjusted, if your doctor indicates, and according to your potassium blood levels.

Eplerenone 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, you may need to have potassium blood levels checked more frequently (see also “Do not take Eplerenone Tarbis Farma”).

In elderly patients: no initial dose adjustment is necessary.

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

If you take more Eplerenone Tarbis Farma than you should

If you take more Eplerenone Tarbis Farma 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, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eplerenone Tarbis Farma

If it is almost time for your next dose, skip the dose you missed and take the next dose at the scheduled time.

Otherwise, take the tablet as soon as you remember, provided that more than 12 hours have passed since the scheduled time. Go back to taking your medicine as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Eplerenone Tarbis Farma

It is important to keep taking Eplerenone Tarbis Farma as your doctor has told you, unless your doctor tells you to stop.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen:

Seek medical attention immediately

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

These are symptoms of angioedema, a rare side effect (affecting up to 1 in 100 people).

Other side effects reported include:

Common side effects(may affect up to 1 in 10 people):

• high levels of potassium in the blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• fainting
• dizziness
• high levels of cholesterol in the blood
• insomnia (difficulty sleeping)
• headache
• heart problems, such as irregular heartbeats and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasms
• increased levels of urea in the blood
• increased levels of creatinine in the blood, which may indicate kidney problems

Uncommon side effects(may affect up to 1 in 100 people):

• infection
• eosinophilia (an increase in certain white blood cells)
• low levels of sodium in the blood
• dehydration
• high levels of triglycerides (fats) 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
• 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, pharmacist, or nurse. 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 their website: https://www.notificaram.es.

By reporting side 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 which is stated on the packaging and outer carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone Tarbis Farma

The active substance is eplerenone.

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

Each Eplerenone 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 Eplerenone Tarbis Farma and contents of the pack

Film-coated tablets.

Eplerenone Tarbis Farma 25 mg film-coated tablets EFG

Film-coated tablets, round, biconvex, light yellow in color, approximately 6.0 mm in diameter and 3.0 mm in thickness, engraved with a “V” on one side and “68” on the other side.

Eplerenone Tarbis Farma 50 mg film-coated tablets EFG

Film-coated tablets, round, biconvex, light yellow in color, approximately 8.0 mm in diameter and 3.5 mm in thickness, engraved with a “V” on one side and “67” on the other side.

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

HDPE containers: 30 and 90 tablets.

Not all 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

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Eplerenone Amarox 25 mg/50 mg film-coated tablets

Spain: Eplerenona Tarbis Farma 25 mg/50 mg film-coated tablets EFG

Netherlands: Eplerenon Amarox 25 mg/50 mg film-coated tablets

Date of the last revision of this leaflet:

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