INSPRA 25 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Inspra, 25 mg, Film-Coated Tablets
3. Inspra, 50 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet
4. What is Inspra and what is it used for
5. Important information before taking Inspra
   1. When not to take Inspra:
   2. Warnings and precautions
   3. Children and adolescents
   4. Inspra and other medicines
   5. Inspra with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Inspra contains lactose monohydrate
6. How to take Inspra
   1. If you take more Inspra than you should
   2. If you forget to take Inspra
   3. Stopping Inspra
7. Possible side effects
   1. If you experience any of the following symptoms, seek medical attention immediately:
   2. Reporting side effects
8. How to store Inspra
9. Contents of the pack and other information
   1. What Inspra contains
   2. What Inspra looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. Mylan Healthcare Sp. z o.o.
   6. Other sources of information

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package 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 case 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 you are allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6)
• if you have high levels of potassium in the blood (hyperkalemia)
• if you are taking medicines that help remove excess fluid from the body (potassium-sparing diuretics)
• if you have severe kidney disease
• if you have severe liver disease
• if you are taking antifungal medicines (ketoconazole or itraconazole)
• if you are taking medicines for HIV (nelfinavir or ritonavir)
• if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin)
• if you are taking nefazodone, used to treat depression
• if you are 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 taking Inspra, discuss it with your doctor, pharmacist, or nurse.

• if you have kidney or liver disease (see also "When not to take Inspra")
• if you are taking lithium salts (usually used to treat manic-depressive disorders, also known as bipolar disorders)
• if you are 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

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you 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 (medicines that help remove excess fluid from the body) 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) - taking 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 thus 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 thus 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 case 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) - taking digoxin with Inspra may increase digoxin levels in the blood.
• warfarin (an anticoagulant) - caution should be exercised when taking 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The effect of Inspra during pregnancy has not been evaluated in humans. It is not known whether eplerenone passes into breast milk. Ask your doctor whether you should stop breastfeeding or stop taking Inspra.

Driving and using machines

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

Inspra contains lactose monohydrate

Inspra contains lactose monohydrate (a type of sugar). If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine. Inspra contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Inspra

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Inspra tablets can be taken with or without food. Swallow the tablets whole with a glass of water. Inspra is usually taken with other heart failure medicines, e.g., beta-blockers. The usual starting dose is one 25 mg tablet once daily. After about 4 weeks, your doctor will advise you to increase the dose to 50 mg once daily (one 50 mg tablet or two 25 mg tablets). The maximum dose is 50 mg per day. Your doctor will advise you to have your potassium levels checked before starting Inspra, within the first week, and after one month of treatment, as well as after any dose change. Depending on your potassium levels, your doctor may adjust your dose. If you have mild kidney disease, treatment should be started with one 25 mg tablet per day. If you have moderate kidney disease, treatment should be started with one 25 mg tablet every other day. Your doctor may advise you to adjust your dose, taking into account your potassium levels. Inspra should not be used in patients with severe kidney disease. In patients with mild or moderate liver disease, no dose adjustment is necessary. In case 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: Inspra is not recommended.

If you take more Inspra than you should

If you have taken more Inspra than you should, contact your doctor or pharmacist immediately. 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).

If you forget to take Inspra

If it is almost time for your next dose, skip the missed dose and take the next one at the usual time. In other cases, take the dose as soon as you remember, provided that it is more than 12 hours before your next dose. Then, return to your usual dosing schedule. Do not take a double dose to make up for a forgotten dose.

Stopping Inspra

It is important to take Inspra as advised by your doctor, unless your doctor tells you to stop. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, seek medical attention 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
• 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 you experience any side effects, including those not listed in this leaflet, please inform your 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, you can help provide more information on the safety of this medicine.

5. How to store 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 stated on the carton and blister after EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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), croscarmellose sodium (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 tablets are yellow, film-coated tablets. The tablets are marked with "VLE" on one side and "NSR" above the number "25" on the other side. Inspra 50 mg tablets are yellow, film-coated tablets. The tablets are marked with "VLE" on one side and "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: packaging 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 information about this medicine, contact the 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 about 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/