Prospect: information for theuser

Eplerenone Normon 25 mg film-coated tablets EFG

Eplerenone

Read this prospect carefully beforestarting totakethis medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If youhave any doubts, consult yourdoctororpharmacist.

• This medication has been prescribed to you alone,and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult yourdoctororpharmacist, even if they are not listed in this prospect.See section 4.

1. What isEplerenone Normonand for what it is used

2. What you need to know before starting to takeEplerenone Normon

3. How to takeEplerenone Normon

4. Possible adverse effects

5. Storage ofEplerenone Normon

6. Contents of the package and additional information

Eplerenona Normon belongs to a group of medications known as selective aldosterone blockers. These blockers inhibit the action of aldosterone, a substance produced by the body, which controls blood pressure and cardiac function. Elevated levels of aldosterone can produce changes in the body that lead to heart failure.

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

1. a recent myocardial infarction, in combination with other medications used to treat your heart failure or,
2. persistent mild symptoms, despite the treatment you have been receiving up to this point.

Do not take Eplerenona Normon

• if you are allergic to eplerenone or any of the other ingredients of 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) or "salt tablets" (potassium supplements).
• 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 angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARAs)) at the same time.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Eplerenona Normon:

• if you have kidney or liver disease (see "Do not take Eplerenona Normon").
• 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 eplerenone in children and adolescents have not been established.

Taking Eplerenona Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

You should not take Eplerenona Normon with the following medications (see section "Do not take Eplerenona Normon"):

• 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 Normon, and therefore prolong its effect in the body.
• • potassium-sparing diuretics or potassium supplements (medications that help your body get rid of excess fluids) as these medications increase the risk of high potassium levels in the blood.
  • ACE inhibitors and ARAs (used to treat high blood pressure, heart disease, or certain kidney diseases) at the same time as Eplerenona Normon, as these medications may increase the risk of high potassium levels in the blood.

Inform your doctor if you are taking any of the following medications:

• 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 high levels of lithium in the blood that may cause the following adverse reactions: loss of appetite, vision changes, 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 therefore 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 therefore 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 Normon.
• digoxin (used to treat heart conditions). The levels of digoxin in the blood may increase when taken with Eplerenona Normon.
• warfarin (an anticoagulant medication). Caution is required when administering warfarin doses as high levels of warfarin in the blood may cause changes to Eplerenona Normon 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 Normon, prolonging its effect in the body.
• Hypericum perforatum (St. John's Wort) or St. John's Wort (a medicinal plant product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy) may increase the metabolism of Eplerenona Normon and therefore reduce its effect.

Taking Eplerenona Normon with food, drinks, and alcohol

Eplerenona Normon can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

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

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

Driving and operating machinery

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

Eplerenona Normon 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 for Eplerenona Normon indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Eplerenona Normon tablets can be taken with or without food. Swallow the tablets whole with plenty of water.

Eplerenona Normon 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 Eplerenona Normon, 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.

Eplerenona Normon is not recommended for patients with severe renal disease.

No initial dose adjustment is required for 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 Eplerenona Normon”).

In the elderly: no initial dose adjustment is required.

In children and adolescents: Eplerenona Normon is not recommended.

If you take more Eplerenona Normon than you should

If you take more Eplerenona Normon 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Eplerenona Normon

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, as long as more than 12 hours have elapsed since the usual time for taking 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 Eplerenona Normon

It is essential to continue taking Eplerenona Normon as instructed, unless your doctor tells you to stop treatment.

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

Like all medicines, Eplerenona Normon may cause side effects, although not everyone will experience them.

If you experience any of the following, seek medical attention immediately:solicite atención médica inmediatamente:

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

These are symptoms of angioneurotic edema.

Other side effects reported include:

Frequent side effects(occur in 1 to 10 of every 100 patients):

• myocardial infarction
• elevated potassium levels in the blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• dizziness
• syncope
• high levels of cholesterol in the blood
• headache
• insomnia (difficulty sleeping)
• cardiac discomfort, for example, irregular heartbeats
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• eruption
• itching
• back pain
• muscle spasms
• increased levels of urea in the blood
• elevated levels of creatinine in the blood that may indicate kidney problems.

Rare side effects(occur in 1 to 10 of every 1,000 patients):

• infection
• eosinophilia (increase in certain white blood cells)
• dehydration
• high levels of cholesterol or triglycerides (fats) in the blood
• low sodium levels in the blood
• rapid heartbeats
• inflammation of the gallbladder
• low blood pressure that may cause dizziness when standing up
• thrombosis (blood clot) in the legs
• sore throat
• flatulence
• vomiting
• underactive thyroid
• increased glucose levels in the blood
• decreased sense of touch
• increased sweating
• musculoskeletal pain
• general feeling of illness
• inflammation of the kidney
• gynecomastia 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: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Store below 30 °C.

Do not use this medication after the expiration date that appears on the packaging afterCad. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Eplerenona Normon

The active ingredient is eplerenone. Each tablet contains 25 mg of eplerenone.

The other components (excipients) are:

Core:Microcrystalline cellulose, lactose, sodium croscarmellose, sodium lauryl sulfate, hydroxypropyl methylcellulose, colloidal silica, and magnesium stearate.

Coating:Hydroxypropyl methylcellulose, titanium dioxide (E-171), talc, macrogol 6000, iron oxide red (E-172), and iron oxide yellow (E-172).

Appearance of the product and content of the packaging

Eplerenona Normon 25 mg is presented in the form of film-coated tablets. They are cream-colored, round, biconvex, and have the imprint “25”. Each package contains 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Eplerenona Normon 50 mg film-coated tablets EFG

This leaflet was approved in June 2015

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