Inspra 50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Inspra 50 mg film-coated tablets

eplerenone

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

Contents of the leaflet

1. What Inspra is and what it is used for
2. What you need to know before taking Inspra
3. How to take Inspra
4. Possible side effects
5. Storage of Inspra
6. Contents of the pack and other information

1. What Inspra is and what it is used for

Inspra 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 controls blood pressure and heart function. High levels of aldosterone may cause changes in the body that lead to heart failure.

Inspra is used to treat heart failure to prevent its worsening and to reduce hospitalization in patients who have:

1. recently had a myocardial infarction, in combination with other medicines used to treat heart failure, or
2. persistent mild symptoms despite ongoing treatment.

2. What you need to know before taking Inspra

Do not take Inspra

• if you are allergic to eplerenone or to any of the other ingredients of this medicine (listed in section 6)
• if you have high levels of potassium in your blood (hyperkalemia)
• if you are taking medicines 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 (ritonavir or nelfinavir)
• if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin)
• if you are taking nefazodone for depression
• if you are taking, at the same time, medicines used to treat certain heart conditions or high blood pressure (such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARBs)).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Inspra.

• if you have kidney or liver disease (see also "Do not take Inspra")
• if you are taking lithium (commonly used for manic-depressive disorder, 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.

Taking Inspra with other medicines

Tell 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 Inspra, thereby prolonging its effect in the body.

• Diuretics known as potassium-sparing diuretics (medicines that help your body eliminate excess fluid) or potassium supplements (salt tablets), as these medicines increase the risk of high potassium levels in the blood.

• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor antagonists (ARBs) 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 disorder, 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 the following adverse reactions: loss of appetite, vision disturbances, tiredness, 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 Inspra.

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

• Warfarin (an anticoagulant medicine): Caution is required when warfarin is administered, as high levels of warfarin in the blood may alter the effect of Inspra in the body.

• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for treating HIV infection), 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 Inspra, thereby prolonging its effect in the body.

• Hypericum perforatum or 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 Inspra and thus reduce its effect.

Taking Inspra with food and drink

Inspra may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. The effect of Inspra 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 Inspra, you may feel dizzy. If this occurs, do not drive or operate machinery.

Inspra contains lactose

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

Inspra contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Inspra

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Inspra is usually administered together with other medicines for heart failure, for example, beta-blockers. The usual starting 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 dosage regimen is 50 mg per day.

Blood potassium levels should be measured before starting treatment with Inspra, during the first week, and one month after starting treatment or after any dose adjustment. Your doctor may adjust the dose based on your blood potassium levels.

If you have mild renal impairment, you should start treatment with one 25 mg tablet daily. If you have moderate renal impairment, you should start treatment with one 25 mg tablet every other day. These doses may be adjusted, as directed by your doctor, according to your blood potassium levels.

Inspra is not recommended in patients with severe renal impairment.

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

In elderly patients: no initial dose adjustment is required.

In children and adolescents: Inspra is not recommended.

If you take more Inspra than you should

If you take more Inspra than you should, inform your doctor or pharmacist immediately. If you have taken too much medicine, 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 medicine and the amount ingested.

If you forget to take Inspra

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 tablet as soon as you remember, provided that more than 12 hours remain before the time for taking the next tablet. Then continue taking your medicine as usual.

Do not take a double dose to make up for a missed dose.

If you stop taking Inspra

It is important to continue taking Inspra 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 (affecting up to 1 in 100 people).

Other reported adverse effects include:

Common adverse effects (may affect up to 1 in 10 people):

• elevated potassium levels in blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness or headache)
• fainting
• dizziness
• elevated cholesterol levels in blood
• insomnia (difficulty sleeping)
• headache
• heart problems, for example, irregular heartbeats and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• abnormal kidney function
• rash
• itching
• back pain
• weakness
• muscle spasm
• increased levels of urea in blood
• elevated creatinine levels in blood, 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 sodium levels in blood
• dehydration
• elevated triglyceride (fat) levels in blood
• rapid heartbeat
• inflammation of the gallbladder
• drop in blood pressure that may cause dizziness upon standing
• thrombosis (blood clot) in the legs
• sore throat
• flatulence
• underactive thyroid
• increased blood glucose
• reduced sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in certain blood tests

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Inspra

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging and outer carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inspra

The active substance in Inspra film-coated tablets is eplerenone. Each tablet contains 50 mg of eplerenone.

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

The yellow opadry coating of Inspra 50 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 Inspra and contents of the pack

The Inspra 50 mg tablet is a yellow film-coated tablet. It is marked “VLE” on one side and “NSR” above “50” on the other side.

Inspra 50 mg film-coated tablets are available in cartons with PVC opaque/Al blisters containing 10, 20, 28, 30, 50, 90, 100 or 200 tablets, and in unit-dose PVC opaque/Al blisters containing 10x1, 20x1, 30x1, 50x1, 90x1, 100x1 or 200x1 (10 cartons of 20x1) tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Fareva Amboise
Zone Industrielle
29 route des Industries
37530 Pocé-sur-Cisse
France

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
Calle General Aranaz, 86
28027 Madrid
Spain

Inspra 50 mg film-coated tablets are authorised in the following European Economic Area member states under 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

Date of the latest revision of this leaflet: March 2021

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