Leaflet: information for the user

Eplerenona Stada 50 mg film-coated tablets EFG

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

Eplerenona belongs to a group of medications 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. Elevated levels of aldosterone can produce changes in the body that lead to heart failure.

Eplerenona is used to treat heart failure to prevent worsening and reduce hospitalization if you have:

Do not take Eplerenona Stada

• if you are allergic to eplerenona or any of the other ingredients in this medication (listed in section 6)
• if you have high levels of potassium in your blood (hyperkalemia)
• if you are taking medications that help your body get rid of excess fluids (potassium-sparing diuretics)
• if you have severe kidney disease
• if you have severe liver disease
• if you are taking medications used to treat fungal infections (ketoconazole or itraconazole)
• if you are taking medications 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 to treat depression
• if you are taking medications used to treat certain heart or high blood pressure conditions (such as ACE inhibitors and ARBs) at the same time.

Contraindications and precautions

Consult your doctor or pharmacist before starting to take Eplerenona Stada.

• if you have kidney or liver disease (see “Do not take Eplerenona Stada”)
• if you are taking lithium (usually used to treat manic-depressive disorders, also known as bipolar disorder)

• if you are taking tacrolimus or cyclosporine (used to treat skin conditions such as psoriasis or eczema and to prevent organ transplant rejection)

Children and adolescents

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

Use of Eplerenona Stada with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (used to treat HIV infections), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medications reduce the metabolism of eplerenona, and thus prolong its effect in the body.
• Potassium-sparing diuretics or potassium supplements (such as salt tablets), as these medications increase the risk of high potassium levels in the blood.
• ACE inhibitors and ARBs at the same time (used to treat high blood pressure, heart disease, or certain kidney diseases), as these medications may increase the risk of high potassium levels in the blood.
• Lithium (used to treat manic-depressive disorders, also known as bipolar disorder). The use of lithium 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 cause 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 organ transplant rejection). These medications may cause kidney problems and thus increase the risk of high potassium levels in the blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs – certain pain relievers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medications 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 diseases), may cause a decrease in blood pressure and dizziness when standing up.
• Tricyclic antidepressants, such as amitriptyline or amoxapine (used to treat depression), antipsychotics (also known as neuroleptics), such as chlorpromazine or haloperidol (used to treat psychiatric disorders), amifostine (used during cancer chemotherapy), and baclofen (used to treat muscle spasms). These medications may cause a decrease in blood pressure and dizziness when standing up.
• Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions), and tetracosactide (used primarily to diagnose and treat adrenal gland disorders) may reduce the blood pressure-lowering effect of eplerenona.
• Digoxin (used to treat heart conditions). The levels of digoxin in the blood may increase when taken with eplerenona.
• Warfarin (an anticoagulant): Caution is required when administering doses of warfarin due to the risk of high warfarin levels in the blood, which may modify the effect of eplerenona in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medication used to treat HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart conditions and high blood pressure) may reduce the metabolism of eplerenona, prolonging its effect in the body.
• St. John's Wort (Hypericum perforatum) or rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy) may increase the metabolism of eplerenona and thus reduce its effect.

Taking Eplerenona Stada with food and drinks

Eplerenona can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The effect of eplerenona during pregnancy in humans has not been evaluated.

The elimination of eplerenona in breast milk is unknown. Your doctor will decide with you whether to stop treatment or breastfeeding.

Driving and operating machinery

After taking eplerenona, you may feel dizzy. If this happens, do not drive or operate machinery.

This medication contains lactose and sodium

This medication contains lactose.If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Eplerenone tablets can 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 a day, increasing after 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 determinations should be performed before starting treatment with eplerenone, 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 blood potassium levels.

If you have mild renal insufficiency, you should start treatment with one 25 mg tablet per day, and if you have moderate renal insufficiency, you should start treatment with one 25 mg tablet every other day. These doses may be adjusted, if your doctor indicates, and in accordance with your blood potassium levels. Eplerenone is not recommended for patients with severe kidney disease.

No initial dose adjustment is required in patients with mild to moderate liver insufficiency. If you have any liver or kidney disease, you may need to have your blood potassium levels checked more frequently (see also "Do not take Eplerenone Stada").

In elderly patients: no initial dose adjustment is required.

In children and adolescents: eplerenone is not recommended.

If you take more Eplerenone Stada 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 will be 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Eplerenone Stada

If it is almost time to take the next tablet, skip the dose you forgot and take the next tablet at the usual time. Otherwise, take the tablet as soon as you remember, provided it has been more than 12 hours since the time you were supposed to take the next tablet. Resume your medication as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eplerenone Stada

It is essential to continue taking eplerenone as instructed, unless your doctor tells you to stop treatment. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side 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 angioneurotic edema, a rare side effect (affecting up to 1 in 100 people).

Other reported side effects include:

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

• Elevated potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea,
• nausea, dizziness, or headache)
• Dizziness
• Fainting
• High cholesterol levels in the blood
• Insomnia (difficulty sleeping)
• Headache
• Cardiac discomfort, for example, irregular heartbeats and heart failure
• Cough
• Constipation
• Low blood pressure
• Diarhea
• Nausea
• Vomiting
• Abnormal kidney function
• Rash
• Itching
• Back pain
• Weakness
• Muscle spasms
• Increased urea levels in the blood
• Elevated creatinine levels in the blood that may indicate kidney problems

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

• Infection
• Eosinophilia (increased levels of certain white blood cells)
• Low sodium levels in the blood
• Dehydration
• Elevated triglyceride levels (fats) in the blood
• Fast heartbeats
• Bile duct inflammation
• Low blood pressure that may cause dizziness when standing
• Thrombosis (blood clot) in the legs
• Sore throat
• Flatulence
• Underactive thyroid
• Increased blood glucose
• Decreased sense of touch
• Increased sweating
• Musculoskeletal pain
• General discomfort
• Kidney inflammation
• Enlarged breasts in men
• Changes in certain blood tests.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children. This medication does not require special storage conditions.

Do not use this medication after the expiration date (CAD) that appears on the packaging and outer carton. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Eplerenona Stada

The active ingredient of the film-coated tablets of Eplerenona Stada is eplerenone. Each tablet contains 50 mg of eplerenone.

Eplerenona Stada 50 mg also contains the following components in the tablet core: lactose monohydrate, microcrystalline cellulose (type 101), sodium croscarmellose, hypromellose (Type 2910), microcrystalline cellulose (type 102), sodium lauryl sulfate, talc, and magnesium stearate.

Eplerenona Stada 50 mg contains the following components in the Opadry II white OY-L-28900 coating: lactose monohydrate, hypromellose (Type 2910), titanium dioxide (E171), and macrogol 4000.

Appearance of Eplerenona Stada and content of the packaging

The Eplerenona Stada 50 mg tablet is a white-to-off-white, round, biconvex tablet, marked “CG4” on one face of the tablet and smooth (unmarked) on the other face.

Eplerenona Stada 50 mg film-coated tablets EFG are presented in blisters of PVC/aluminum containing 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern, Barcelona

Spain

[email protected]

Responsible for manufacturing

LICONSA S.A. Laboratories

Avenida Miralcampo 7, Industrial Park Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Last review date of this leaflet:August 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/