Inspra

Package Leaflet: Information for the Patient

Inspra, 25 mg, Film-Coated Tablets

Inspra, 50 mg, Film-Coated Tablets

eplerenone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Inspra and what is it used for

Inspra belongs to a group of medicines called selective aldosterone antagonists. These medicines block the action of aldosterone, a substance produced by the body that controls blood pressure and heart function. Increased levels of aldosterone can cause changes in the body that lead to heart failure.

Inspra is used to treat heart failure to prevent its worsening and reduce the number of hospitalizations in cases of:

• 1. recent myocardial infarction - in combination with other heart failure medicines or
• 2. persistent, mild symptoms despite previous treatment.

2. Important information before taking Inspra

When not to take Inspra:

• if the patient is allergic to eplerenone or any other ingredient of this medicine (listed in section 6)
• if the patient has high levels of potassium in the blood (hyperkalemia)
• if the patient is taking medicines that remove excess fluid from the body (potassium-sparing diuretics)
• if the patient has severe kidney disease
• if the patient has severe liver disease
• if the patient is taking antifungal medicines (ketoconazole or itraconazole)
• if the patient is taking medicines against HIV (nelfinavir or ritonavir)
• if the patient is taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin)
• if the patient is taking nefazodone, used to treat depression
• if the patient is taking medicines used to treat certain heart or blood pressure conditions (so-called ACE inhibitors in combination with angiotensin II receptor antagonists (AIIRA)).

Warnings and precautions

Before starting to take Inspra, the patient should discuss it with their doctor, pharmacist, or nurse.

• if the patient has kidney or liver disease (see also "When not to take Inspra")
• if the patient is taking lithium salts (usually used to treat manic-depressive disorders, also known as bipolar disorders)
• if the patient is taking tacrolimus or cyclosporine (used to treat skin diseases, such as psoriasis or eczema, and to prevent rejection of a transplanted organ)

Children and adolescents

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

Inspra and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines against HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression) - these medicines slow down the metabolism of Inspra, thereby prolonging its effect on the body.
• potassium-sparing diuretics and potassium supplements - these medicines increase the risk of high levels of potassium in the blood.
• ACE inhibitors in combination with angiotensin II receptor antagonists (AIIRA), used to treat high blood pressure, heart disease, and certain kidney diseases - these medicines may increase the risk of high levels of potassium in the blood.
• lithium (usually used to treat manic-depressive disorders, also known as bipolar disorders) - concurrent use of lithium with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) increased lithium levels in the blood, which could cause side effects such as loss of appetite, vision disturbances, fatigue, muscle weakness, and tremors.
• cyclosporine or tacrolimus (used to treat skin diseases, such as psoriasis or eczema, and to prevent rejection of a transplanted organ) - these medicines may cause kidney function disorders and thereby increase the risk of high levels of potassium in the blood.
• non-steroidal anti-inflammatory drugs (NSAIDs - some painkillers, such as ibuprofen, used to relieve pain, stiffness, and inflammation) - these medicines may cause kidney function disorders and thereby increase the risk of high levels of potassium in the blood.
• trimethoprim (used to treat bacterial infections) - may increase the risk of high levels of potassium in the blood.
• alpha-adrenergic 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 changing body position to standing.
• tricyclic antidepressants, such as amitriptyline or amoxapine (used to treat depression), antipsychotic medicines, also known as neuroleptics, such as chlorpromazine or haloperidol (used to treat mental disorders), amifostine (used in cancer chemotherapy), and baclofen (used in cases of increased muscle tension) - these medicines may cause a decrease in blood pressure and dizziness when changing body position to standing.
• glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammatory conditions and certain skin diseases), and tetracosactide (mainly used to diagnose and treat adrenal cortex disorders) - may weaken the blood pressure-lowering effect of Inspra.
• digoxin (used to treat heart disease) - concurrent use with Inspra may increase digoxin levels in the blood.
• warfarin (an anticoagulant) - caution should be exercised when using warfarin, as increased warfarin levels in the blood may disrupt the effect of Inspra on the body.
• erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine used to treat HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart disease and high blood pressure) - slow down the metabolism of Inspra, thereby prolonging its effect on the body.
• St. John's Wort (a herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among other things, to treat epilepsy) - may accelerate the metabolism of Inspra, thereby weakening its effect.

Inspra with food and drink

Inspra can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The effect of Inspra during pregnancy has not been evaluated in humans.

It is not known whether eplerenone passes into human milk. The patient should consult their doctor whether to stop breastfeeding or stop taking the medicine.

Driving and using machines

After taking Inspra, dizziness may occur. In this case, the patient should not drive or operate machinery.

Inspra contains lactose monohydrate

Inspra contains lactose monohydrate (a type of sugar). If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Inspra contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Inspra

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

Inspra tablets can be taken with or without food. The tablets should be swallowed whole, with a large amount of water.

Inspra is usually taken with other heart failure medicines, such as beta-blockers. The usual starting dose is one 25 mg tablet once a day. After about 4 weeks, the doctor will prescribe an increase in the dose to 50 mg once a day (one 50 mg tablet or two 25 mg tablets). The maximum dose is 50 mg per day.

The doctor will prescribe a blood test to check potassium levels before starting Inspra, within the first week, and after one month of treatment, as well as after any dose change. Depending on the potassium level, the doctor may adjust the dose.

If the patient has mild kidney disease, treatment should be started with one 25 mg tablet per day. If the patient has moderate kidney disease, treatment should be started with one 25 mg tablet every other day. The doctor may prescribe a dose adjustment, taking into account the potassium level.

In patients with severe kidney disease, the use of Inspra is contraindicated.

In patients with mild or moderate liver disease, no dose adjustment is necessary. In cases of liver or kidney disease, more frequent monitoring of potassium levels may be necessary (see also "When not to take Inspra").

Elderly patients: no dose adjustment is necessary.

Children and adolescents: the use of Inspra is not recommended.

What to do if you take more Inspra than you should

In case of taking more Inspra than prescribed, the patient should immediately contact their doctor or pharmacist. The most likely symptoms of overdose are low blood pressure (causing dizziness, dizziness, blurred vision, weakness, sudden loss of consciousness) and hyperkalemia (high levels of potassium in the blood), causing muscle cramps, diarrhea, nausea, dizziness, or headache).

What to do if you miss a dose of Inspra

If it is almost time for the next dose, the patient should skip the missed dose and take the next one at the usual time.

In other cases, the patient should take the dose as soon as they remember, provided that the next dose is more than 12 hours away. Then, the patient should return to their usual dosing schedule.

The patient should not take a double dose to make up for the missed dose.

What to do if you stop taking Inspra

It is important to take Inspra as prescribed, unless the doctor advises the patient to stop the treatment.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Inspra can cause side effects, although not everybody gets them.

If any of the following symptoms occur, the patient should seek medical help immediately:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing. These are symptoms of angioedema, a rare side effect that may occur in less than 1 in 100 people.

Other reported side effects include:

Common side effects(may occur in up to 1 in 10 people)

• high levels of potassium in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache)
• fainting
• central dizziness
• high levels of cholesterol in the blood
• insomnia (difficulty sleeping)
• headache
• heart disorders, such as arrhythmias and heart failure
• cough
• constipation
• low blood pressure
• diarrhea
• nausea
• vomiting
• kidney function disorders
• rash
• itching
• back pain
• weakness
• muscle cramps
• high levels of urea in the blood
• high levels of creatinine in the blood, which may indicate kidney function disorders

Uncommon side effects(may occur in up to 1 in 100 people)

• infection
• eosinophilia (an increase in the number of a type of white blood cell)
• low levels of sodium in the blood
• dehydration
• high levels of triglycerides (fats) in the blood
• rapid heart rate
• gallbladder inflammation
• decreased blood pressure, which may cause dizziness when changing body position to standing
• thrombosis (blood clots) in the legs
• sore throat
• bloating
• hypothyroidism
• high levels of glucose in the blood
• numbness
• increased sweating
• musculoskeletal pain
• general feeling of being unwell
• kidney inflammation
• breast enlargement in men
• changes in some blood test results

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder or its representative.

By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Inspra

The medicine should be stored out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the carton and blister after EXP.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Inspra contains

The active substance of Inspra is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.

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

The coating of the Inspra 25 mg and 50 mg film-coated tablets contains opadry yellow: hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), yellow iron oxide (E172), and red iron oxide (E172).

What Inspra looks like and contents of the pack

Inspra 25 mg is a yellow film-coated tablet. The tablets are marked with the name "VLE" on one side and the symbol "NSR" above the number "25" on the other side.

Inspra 50 mg is a yellow film-coated tablet. The tablets are marked with the name "VLE" on one side and the symbol "NSR" above the number "50" on the other side.

Inspra 25 mg and 50 mg film-coated tablets are available in PVC/Al blisters containing 10, 20, 28, 30, 50, 90, 100, or 200 tablets, and in PCV/Al blisters, perforated, divided into single doses, containing 10 x 1, 20 x 1, 30 x 1, 50 x 1, 90 x 1, 100 x 1, or 200 x 1 (10 blisters of 20 x 1) tablets. Not all pack sizes may be marketed.

Pack sizes available in Poland: a pack containing 30 tablets in blisters.

Marketing authorization holder:

Upjohn EESV

Rivium Westlaan 142

2909 LD Capelle aan den IJssel

Netherlands

Manufacturer:

Fareva Amboise

Zone Industrielle

29 route des Industries

37530 Pocé-sur-Cisse

France

Inspra, film-coated tablets, 25 mg and 50 mg, is authorized 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.

Inspra, film-coated tablets, 50 mg, is authorized in the following European Economic Area member states under the name Inspra:

Czech Republic

For more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

tel. 22 546 64 00

Date of last revision of the leaflet:03/2024

Other sources of information

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

http://www.urpl.gov.pl/