Package Insert: Information for the User

Eplerenone Alter 50 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Eplerenone Alter and what is it used for

2. What you need to know before starting to take Eplerenone Alter

3. How to take Eplerenone Alter

4. Possible side effects

5. Storage of Eplerenone Alter

6. Contents of the pack and additional information

Eplerenona Alter 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 may lead to heart failure.

.

Eplerenona Alter 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. mild persistent symptoms, despite the treatment you have been receiving up to this point.

Do not take Eplerenona Alter

• if you are allergic to eplerenona or any of the other components 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)
• 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Eplerenona Alter

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

Taking Eplerenona Alter with other medications

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

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medications for HIV), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression), as these medications reduce the metabolism of Eplerenona Alter, and therefore prolong its effect in the body.
• Diuretics called potassium-savers (medications that help your body get rid of excess fluids) or potassium supplements (salt tablets), as these medications increase the risk of high potassium levels in the blood.

• Lithium (usually 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 that can 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 can 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 can 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.
• ACE inhibitors and ARBs (used to treat high blood pressure, heart disease, or certain kidney diseases) at the same time, as these medications can 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 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 medication): Caution is required when administering warfarin doses because high levels of warfarin in the blood may cause changes to eplerenona in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medication for HIV), 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 St. John's Wort extract, rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy, among other conditions) may increase the metabolism of eplerenona and therefore reduce its effect.

Taking Eplerenona Alter with food and drinks

Eplerenona Alter can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. Eplerenona Alter has not been evaluated for its effect on human pregnancy.

The safety of eplerenona in breastfeeding women is unknown. Your doctor will decide with you whether to stop treatment or breastfeeding.

Driving and operating machinery

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

Eplerenona Alter contains lactose

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

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

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

Eplerenona Alter 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 Alter, 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.EplerenonaAlteris not recommended for patients with severe kidney disease.No initial dose adjustment is necessary 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 Eplerenona Alter").

In elderly patients:No initial dose adjustment is required.

Inchildren and adolescents:Eplerenona Alter is not recommended.

If you take more Eplerenona Alter than you should

If you take more Eplerenona Alter 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 forget to take Eplerenona Alter

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 Eplerenona Alter

It is essential to continue taking Eplerenona Alter 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, this medicine may cause side effects, although not everyone will experience them.

If any of the following occur,seek medical attention immediately:

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

These are the 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)

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

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

• infection

• eosinophilia (increase in certain white blood cells)
• low sodium levels in the blood
• dehydration
• high levels of triglycerides (fats) 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
• underactive thyroid
• increased glucose levels in the blood
• diminished sense of touch

• increased sweating
• musculoskeletal pain

• general malaise
• kidney inflammation
• gynecomastia in men
• Changes in certain blood tests

Reporting of side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance and Medicines for Human Use, Website: 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.

Do not use this medication after the expiration date that appears on the packaging and in the blister pack after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30º C

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

Composition of EplerenoneAlter

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

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, talc, magnesium stearate.

Tablet coating: Hypromellose, Macrogol 400, Polysorbate 80 (E433), Titanium dioxide, Yellow iron oxide (E172) and Red iron oxide (E172).

Appearance of Eplerenone Alter and content of the container

Eplerenone Alter 25 mg film-coated tablets are beige, round, biconvex, and have the inscription ‘’25’’ on one face.

Eplerenone Alter 25 mg film-coated tablets are presented in packs with blisters containing 10, 20, 28, 30, 50, 90, 100 or 200 tablets. Some pack sizes may not be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Adamed Pharma S.A.

Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

Last review date of this leaflet: February 2019

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