Eplerenone Bluefish 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Eplerenona Bluefish 50mg Film-coated Tablets EFG

Read the entire 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, pharmacist or nurse.
• 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 could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

2. What you need to know before taking Eplerenona Bluefish.

3. How to take Eplerenona Bluefish.

4. Possible side effects.

5. How to store Eplerenona Bluefish.

6. Contents of the pack and other information.

1. What Eplerenona Bluefish 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 your 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:

1. recently suffered a myocardial infarction, in combination with other medications used to treat heart failure, or

2. persistent mild symptoms, despite ongoing treatment received up to now.

2. What you need to know before taking Eplerenona Bluefish

Do not take Eplerenona Bluefish

• 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 from groups 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 (nelfinavir or ritonavir),
• 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 (ARA)).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Eplerenona Bluefish,

• if you have kidney or liver disease (see also “Do not take Eplerenona Bluefish”),
• 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.

Other medicines and Eplerenona Bluefish

Inform 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 Eplerenona Bluefish, 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 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 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 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), 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 Bluefish.

• Digoxin (used in the treatment of heart conditions). Blood levels of digoxin may increase when taken together with Eplerenona Bluefish.

• 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 Bluefish 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 Eplerenona Bluefish, 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 Eplerenona Bluefish and thus reduce its effect.

Taking Eplerenona Bluefish with food and drink

Eplerenona Bluefish can be taken with or without food.

Pregnancy and breastfeeding

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 Eplerenona Bluefish 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 Eplerenona Bluefish, you may feel dizzy. If this occurs, do not drive or operate machinery.

Eplerenona Bluefish contains lactose

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

Eplerenona Bluefish contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 25 mg and 50 mg tablet; this is essentially “sodium-free”.

3. How to take Eplerenona Bluefish

Follow exactly the dosing instructions given to you by your doctor or pharmacist. 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, 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 recommended dosage regimen is 50 mg per day.

Serum potassium measurements should be performed before starting treatment with eplerenone, during the first week, and one month after initiating treatment or after any dose adjustment. Your doctor may adjust the dose based on your serum potassium levels.

Patients with renal or hepatic impairment

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 serum potassium levels. Eplerenone is not recommended in patients with severe renal disease.

No initial dose adjustment is required in patients with mild to moderate hepatic impairment. If you have liver or kidney disease, more frequent serum potassium monitoring may be necessary (see also "Do not take Eplerenona Bluefish").

Elderly patients

No initial dose adjustment is required in elderly patients.

Use in children and adolescents

Eplerenone is not recommended for use in children and adolescents.

If you take more Eplerenona Bluefish 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 telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Eplerenona Bluefish

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 Eplerenona Bluefish

It is important to continue taking eplerenone 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 (may affect up to 1 in 100 patients).

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),
• dizziness,
• fainting,
• elevated blood cholesterol levels,
• insomnia (difficulty sleeping),
• headache,
• heart-related discomfort such as irregular heartbeat and heart failure,
• cough,
• constipation,
• low blood pressure,
• diarrhea,
• nausea,
• vomiting,
• abnormal kidney function,
• rash,
• itching,
• back pain,
• weakness,
• muscle 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,
• eosinophilia (increase in certain white blood cells),
• low blood sodium levels,
• dehydration,
• elevated blood triglyceride (fats) levels,
• rapid heartbeat,
• inflammation of the gallbladder,
• drop in blood pressure that may cause dizziness when standing up,
• thrombosis (blood clot) in the legs,
• sore throat,
• flatulence,
• underactive thyroid,
• increased blood glucose,
• reduced sense of touch,
• increased sweating,
• musculoskeletal pain,
• weakness and 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, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenone Bluefish

Keep this medicine out of 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 blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste.

Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eplerenone Bluefish

• • The active substance is eplerenone. Each tablet contains 50 mg of eplerenone.
• The other components are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose (Type A), hypromellose (Benecel E3), talc and magnesium stearate.

The yellow opadry film coating of Eplerenone Bluefish 50 mg film-coated tablets contains macrogol/PEG 6000, HPMC 2910/hypromellose 5cP, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

Appearance of Eplerenone Bluefish and contents of the pack

Eplerenone Bluefish 50 mg film-coated tablets are presented as round, biconvex, yellow tablets, marked with "E50" on one side.

Eplerenone Bluefish film-coated tablets are available in cartons with opaque PVC/white Al blisters containing 10, 20, 28, 30, 50, 90, 100, and 200 tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden

Manufacturer

Pharmathen S.A.
Dervenakion 6, Pallini 15351, Attikis
Greece
and
Pharmathen International S.A.
Industrial Park Sapes Rodopi Perfecture, Block No. 5, Rodopi, 69300
Greece

Local Representative:

Bluefish Pharma S.L.U.,
P.O. Box 36007, 28320 Madrid,
Branch Office 36

This medicinal product is authorised in EU Member States under the following names:

Date of the most recent review of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es