Prospecto: information for the user

Inspra 50 mg film-coated tablets

eplerenone

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they present 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 prospect. See section 4.

1.What isInspraand for what it is used

2.What you need to knowbefore starting totakeInspra

3.How to takeInspra

4.Possible adverse effects

5Storage ofInspra

6.Contents of the package and additional information

Insprabelongs 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.

Insprais 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 so far.

Do not take Inspra

• 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)
• 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, pharmacist, or nurse before starting to take Inspra.

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

Use of Inspra 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 Inspra, and thus prolong its effect in the body.
• Diuretics called potassium-sparing diuretics or potassium supplements (potassium tablets), as these medications 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 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 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.
• 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 Inspra.
• Digoxin (used to treat heart conditions). The levels of digoxin in the blood may increase when taken with Inspra.
• Warfarin (an anticoagulant medication): Caution is required when administering warfarin doses, as high levels of warfarin in the blood may cause changes in the effect of Inspra 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 Inspra, prolonging its effect in the body.
• St. John's Wort (Hypericum perforatum), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy) may increase the metabolism of Inspra and thus reduce its effect.

Taking Inspra with food and drinks

Inspra can be taken with or without food.

Pregnancy and breastfeeding

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.Inspra has not been evaluated in humans during pregnancy.

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

Driving and operating machinery

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

Inspra contains lactose

Inspra contains lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Inspra 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 again with your doctor or pharmacist.

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

Insprais usually taken 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 levels should be determined before starting treatment withInspra, 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 kidney failure, you should start treatment with one 25 mg tablet per day, and if you have moderate kidney failure, 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.

Insprais not recommended for patients with severe kidney disease.

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

Inelderly patients: no initial dose adjustment is required.

In children and adolescents:Insprais not recommended.

If you take more Inspra than you should

If you take moreInsprathan 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 Inspra

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 time for 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 Inspra

It is essential to continue takingInspraas indicated by your doctor, 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.

Like all medications, this medicationmay 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):

• high levels of potassium in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• syncope (fainting)
• 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
• hypothyroidism (underactive thyroid)
• increased glucose levels in the blood
• diminished sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• gynecomastia (breast enlargement) in men.
• Changes in certain blood tests

Reporting of side effects

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

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 that appears on the packaging and outer carton after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash.Deposit containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, please ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Inspra

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

The other components are lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), sodium lauryl sulfate, talc (E553b) and magnesium stearate (E470b).

The yellow opadry coating ofInspra50 mg film-coated tablets contains hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), yellow iron oxide (E172) and red iron oxide (E172).

Appearance of Inspraand packaging contents

TheInspra50 mg tablet is a yellow film-coated tablet. They are marked “VLE” on one face and “NSR” above “50” on the other face of the tablet.

Inspra50 mg film-coated tablets are presented in packs with blisters of PVC opaque/Alcontaining 10, 20, 28, 30, 50, 90, 100 or 200 tablets and in single-dose blisters of PVC opaque/Al perforated containing 10x1, 20x1, 30x1, 50x1, 90x1 100x1 or 200x1 (10 packs of 20x1) tablets.They may only be marketed in some packaging sizes.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

Fareva Amboise.

Zone Industrielle

29 route des Industries

37530 Pocé-sur-Cisse

France

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

Inspra50 mg film-coated tablets are authorized in the following member states of the European Economic Area with the name Inspra:

Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom

Last review date of this leaflet: March 2021

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