Inspra

Patient Information Leaflet

Inspra, 25 mg, film-coated tablets
Inspra, 50 mg, film-coated tablets
eplerenone
Please read carefully the entire leaflet before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Inspra is and what it is 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 Inspra is and what it is used for

Inspra belongs to a group of medicines known as selective aldosterone antagonists. These medicines block the action of aldosterone, a substance produced by the body that regulates blood pressure and heart function. Elevated levels of aldosterone may cause changes in the body leading to heart failure.
Inspra is used in the treatment of heart failure to prevent worsening of the condition and to reduce the number of hospitalizations in the following cases:

1. following a recent heart attack – in combination with other medicines used for heart failure, or
2. persistent, mild symptoms despite prior treatment.

2. Important information before using Inspra

When not to use Inspra:

• if the patient is allergic to eplerenone or any of the other ingredients 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 antiviral medicines for 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 conditions or high blood pressure (so-called angiotensin-converting enzyme (ACE) inhibitors in combination with angiotensin II receptor antagonists (AIIRAs)).

Warnings and precautions
Before starting treatment with Inspra, discuss this with your doctor, pharmacist, or nurse.

• if the patient has kidney or liver disease (see also section "When not to use 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 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.

Inspra with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for 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 in the body.
• Potassium-sparing diuretics (medicines that help remove excess fluid from the body) and potassium supplements – these medicines increase the risk of high potassium levels in the blood.
• Angiotensin-converting enzyme (ACE) inhibitors in combination with angiotensin II receptor antagonists (AIIRAs), used to treat high blood pressure, heart disease, and certain kidney conditions – these medicines may increase the risk of high potassium levels in the blood.
• Lithium (usually used to treat manic-depressive disorders, also known as bipolar disorders) – taking lithium together with diuretics and ACE inhibitors (used to treat high blood pressure and heart conditions) has increased lithium levels in the blood, which could lead to adverse effects such as loss of appetite, vision disturbances, fatigue, muscle weakness, and muscle tremors.
• 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 dysfunction and thereby increase the risk of high potassium levels 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 dysfunction and thereby 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-adrenolytics, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions) – may cause low blood pressure and dizziness upon changing to an upright position.
• 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 in cancer chemotherapy), and baclofen (used in cases of increased muscle tone) – these medicines may cause low blood pressure and dizziness upon changing to an upright position.
• Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammatory conditions and certain skin diseases), and tetracosactide (used mainly in diagnosing and treating adrenal cortex disorders) – may weaken the blood pressure-lowering effect of Inspra.
• Digoxin (used to treat heart conditions) – concomitant use with Inspra may increase digoxin levels in the blood.
• Warfarin (an anticoagulant) – caution is advised when using warfarin, as increased warfarin levels in the blood may interfere with the effect of Inspra.
• 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 conditions and high blood pressure) – these slow down the metabolism of Inspra, thereby prolonging its effect in the body.
• St. John's wort (a herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, in the treatment of epilepsy) – these may accelerate the metabolism of Inspra, thereby weakening its effect.

Inspra with food and drink
Inspra may be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. The effects of Inspra during pregnancy have not been evaluated in humans.
It is not known whether eplerenone passes into human milk. Consult your doctor whether to discontinue breastfeeding or to stop taking the medicine.

Driving and operating machinery
Dizziness may occur after taking Inspra. In such a case, do not drive or operate machinery.

Inspra contains lactose monohydrate
Inspra contains lactose monohydrate (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Inspra contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Inspra

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Inspra tablets may be taken with or without food. Swallow the tablets whole with a large amount of water.
Inspra is usually taken together with other medicines used to treat heart failure, such as beta-blockers. The usual starting dose is one 25 mg tablet once daily. After about 4 weeks, your doctor will usually recommend increasing 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 recommend measuring blood potassium levels before starting treatment with Inspra, during the first week of treatment, after one month of treatment, and after any dose adjustment. Depending on the blood potassium level, your doctor may adjust the dose of the medicine.
If the patient has mild kidney disease, treatment should be started with one 25 mg tablet daily. If the patient has moderate kidney disease, treatment should be started with one 25 mg tablet every other day. Your doctor may recommend adjusting the dose based on blood potassium levels.
Inspra must not be used in patients with severe kidney disease.
In patients with mild or moderate liver disease, no adjustment of the initial dose is necessary. In cases of liver or kidney disease, more frequent monitoring of blood potassium levels may be required (see also "When not to use Inspra").
Elderly patients: no adjustment of the initial dose is required.
Children and adolescents: use of Inspra is not recommended.
Taking more Inspra than recommended
If you take more Inspra than you should, contact your doctor or pharmacist immediately. The most likely symptoms of overdose are low blood pressure (causing dizziness, blurred vision, weakness, sudden loss of consciousness) and hyperkalemia (high potassium levels in the blood), which may cause 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 tablet at the usual time.
Otherwise, take the missed tablet as soon as you remember, provided that there is more than 12 hours until the time for the next dose. Then return to your regular dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Inspra
It is important to take Inspra exactly as prescribed, unless your doctor advises you to stop treatment.
If you have any further questions about the use of this medicine, consult 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 symptoms occur, seek immediate medical help:

• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria and breathing difficulties. These are symptoms of angioedema, an uncommon adverse effect (may occur in up to 1 in 100 people).

Other reported adverse effects include:
Common adverse effects (may occur in up to 1 in 10 people)

• increased blood potassium levels (symptoms include: muscle cramps, diarrhoea, nausea, dizziness or headache)
• fainting
• central dizziness
• increased blood cholesterol levels
• insomnia (difficulty falling or staying asleep)
• headache
• heart disorders, e.g. heart rhythm disturbances and heart failure
• cough
• constipation
• low blood pressure
• diarrhoea
• nausea
• vomiting
• kidney function disorders
• rash
• itching
• back pain
• weakness
• muscle cramps
• increased blood urea levels
• increased blood creatinine levels, which may indicate kidney dysfunction

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

• infection
• eosinophilia (increased number of one type of white blood cells)
• low blood sodium levels
• dehydration
• increased blood triglyceride (fat) levels
• rapid heart rate
• cholecystitis (inflammation of the gallbladder)
• low blood pressure, which may cause dizziness upon standing
• deep vein thrombosis (blood clots in the lower limbs)
• sore throat
• bloating
• hypothyroidism
• increased blood glucose levels
• reduced sense of touch
• increased sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in males
• changes in certain blood test results

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder or its representative.
Reporting adverse effects helps 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 pack following EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Inspra contains
The active substance in Inspra is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.
The other ingredients are: lactose monohydrate, microcrystalline cellulose (E460), sodium
crosscarmellose (E468), hypromellose (E464), sodium lauryl sulfate, talc (E553b), and magnesium
stearate (E470b).
The film coating of Inspra 25 mg and 50 mg 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 tablet is a yellow film-coated tablet. The tablets are marked with the code "VLE" on one side and the symbol "NSR" above the number "25" on the other side.
Inspra 50 mg tablet is a yellow film-coated tablet. The tablets are marked with the code "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 perforated, unit-dose divided PVC/Al blisters 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.
Inspra 25 mg film-coated tablets are also available in HDPE bottles containing 100 tablets.
Not all pack sizes may be marketed.
Pack sizes available in Poland: pack containing 30 tablets in blisters.

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

Inspra 25 mg and 50 mg film-coated tablets are authorised in the following European Economic Area countries under the name Inspra:
Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

Inspra 50 mg film-coated tablets are authorised in the following European Economic Area country under the name Inspra:
Czech Republic

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00