PACKAGE LEAFLET: INFORMATION FOR THE USER

Inspra 25 mg film-coated tablets, 50 mg film-coated tablets

eplerenone
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Inspra is and what it is used for
What you need to know before taking Inspra
How to take Inspra
Possible side effects
How to store Inspra
Contents of the pack and other information

1. What Inspra is and what it is used for

Inspra belongs to a class of medicines known as selective aldosterone blockers. These agents
inhibit the action of aldosterone, a substance produced by the body that regulates blood pressure and
cardiac function. Elevated levels of aldosterone can cause changes in the body that lead to
heart failure.
Inspra is used to treat your heart failure, to prevent its worsening, and to reduce
hospitalization, if:

you have recently had a heart attack, in combination with other medicines used to treat heart failure, or
you have moderate and persistent symptoms despite the treatment you have received so far.

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 eliminate excess body fluids (potassium-sparing diuretics)
If you have severe kidney disease
If you have severe liver disease
If you are taking medicines used to treat fungal infections (ketoconazole or itraconazole)
If you are taking antiviral medicines for the treatment of HIV (nelfinavir or ritonavir)
If you are taking antibiotics for the treatment of bacterial infections (clarithromycin or telithromycin)
If you are taking nefazodone for the treatment of depression
If you are taking medicines for the treatment of certain heart conditions or high blood pressure (called angiotensin-converting enzyme inhibitors [ACE inhibitors] and angiotensin receptor blockers [ARBs]) together.

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 disorders, also called bipolar disorders)
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.
Other medicines and Inspra
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine:

itraconazole or ketoconazole (for treatment of fungal infections), ritonavir, nelfinavir (antiviral medicines for treatment of HIV), clarithromycin, telithromycin (for treatment of bacterial infections), or nefazodone (for depression), as these medicines reduce the elimination of Inspra, prolonging its effect.
potassium-sparing diuretics (medicines that help eliminate excess body fluids) and 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 blockers (ARBs) together (used in the treatment of high blood pressure, heart diseases, or certain kidney conditions), because these medicines can increase the risk of high potassium levels in the blood.
Lithium (usually used for manic-depressive disorders, also called bipolar disorders). It has been shown that the use of lithium together with diuretics and ACE inhibitors (used in the treatment of high blood pressure and heart disorders) increases lithium levels in the blood, which may cause the following adverse effects: loss of appetite, blurred vision, fatigue, muscle weakness, muscle cramps.
Cyclosporine or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent transplant rejection). These medicines can cause kidney problems and thus 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 can 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 cause a drop in blood pressure and dizziness when standing up.
Tricyclic antidepressants such as amitriptyline or amoxapine (for treatment of depression), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (for treatment of psychiatric disorders), amifostine (used in anticancer chemotherapy), and baclofen (used to treat muscle spasms). These medicines may cause low blood pressure and dizziness when standing up.
Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions) and tetracosactide (mainly used for diagnosis and treatment of adrenal cortex disorders), may reduce the effect of Inspra.
Digoxin (used to treat heart conditions). Digoxin levels in the blood may increase when administered together with Inspra.
Warfarin (an anticoagulant medicine): caution is recommended with warfarin, as high levels of warfarin in the blood may alter the effects of Inspra.
Erythromycin (used to treat bacterial infections), saquinavir (antiviral medicine for treatment of HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for treatment of heart conditions and high blood pressure) reduce the elimination of Inspra, prolonging its effect.
St. John’s wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (also used to treat epilepsy) may increase the elimination of Inspra and thus reduce its effects.

Inspra with food and drink
Inspra can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
The effect of Inspra has not been evaluated in humans during pregnancy.
It is not known whether eplerenone is excreted in breast milk. Together with your doctor, you will need to decide whether to stop breastfeeding or discontinue the medicine.
Driving and using machines
After taking Inspra, you may experience dizziness. If this occurs, do not drive or operate machinery.
For those engaged in sports: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Inspra contains lactose
Inspra contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Inspra contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Inspra

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The Inspra tablets can be taken with or without food. Swallow the tablets whole with a sufficient amount of water.
Inspra is generally administered together with other medicines for heart failure, such as beta-blockers. The usual starting dose is one 25 mg tablet once daily, which is generally increased after 4 weeks to 50 mg once daily (one 50 mg tablet or two 25 mg tablets). The maximum daily dose is 50 mg.
Serum potassium levels should be measured before starting treatment with Inspra, within the first week, and within the first month of treatment or after any dose adjustment. Your doctor may adjust the dose based on your serum potassium levels.
If you have mild renal impairment, treatment should be initiated with one 25 mg tablet once daily. If you have moderate renal impairment, treatment should be initiated with one 25 mg tablet every other day. Depending on your doctor’s assessment and your serum potassium levels, these doses may be adjusted. Inspra is not recommended in patients with severe renal impairment.
In patients with mild to moderate hepatic impairment, no initial dose adjustment is required. If you have kidney or liver problems, you may require more frequent monitoring of your blood potassium levels (see also “Do not take Inspra ").
For elderly patients: no initial dose adjustment is necessary.
For children and adolescents: the use of Inspra is not recommended.
If you take more Inspra than you should
If you have taken too many Inspra tablets, contact your doctor or pharmacist immediately.
If you have taken an overdose, the most likely symptoms are low blood pressure (feeling dizzy, lightheadedness, blurred vision, weakness, sudden loss of consciousness) or hyperkalaemia (high potassium levels in the blood), which may present as muscle cramps, diarrhoea, 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 your usual time. Otherwise, take it as soon as you remember, provided that at least 12 hours will elapse before taking the next dose. Then continue taking the medicine as before.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Inspra
It is important to take Inspra as prescribed unless your doctor tells you to stop treatment.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If you experience any of the following symptoms:
Tell your doctor immediately

Swelling of the face, tongue or throat
Difficulty swallowing
Hives and breathing difficulties

These are symptoms of angioedema, an uncommon side effect (may affect up to 1 in 100 people).

Other reported side effects include:
Common (may affect up to 1 in 10 people):

High levels of potassium in the blood (symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache)
Fainting
Dizziness
Increased cholesterol levels in the blood
Insomnia (difficulty sleeping)
Headache
Heart problems, e.g. irregular heartbeat, heart failure
Cough
Constipation
Low blood pressure
Diarrhoea
Nausea
Vomiting
Impaired kidney function
Skin rash
Itching
Back pain
Weakness
Muscle spasms
Increased levels of urea in the blood
Increased levels of creatinine in the blood, which may indicate kidney problems

Uncommon (may affect up to 1 in 100 people):

Infections
Eosinophilia (increase in certain white blood cells)
Low sodium levels in the blood
Dehydration
Increased levels of triglycerides (fats) in the blood
Rapid heartbeat
Inflammation of the gallbladder
Decreased blood pressure which may cause dizziness when standing up
Blood clots (thrombosis) in the legs
Sore throat
Flatulence
Reduced thyroid function
Increased blood sugar levels
Reduced sensitivity to touch
Increased sweating
Musculoskeletal pain
General feeling of malaise
Kidney inflammation
Breast enlargement in men
Changes in blood test values

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 requires no special storage conditions.
Do not use this medicine after the expiry date stated on the pack and blister after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Inspra contains
The active substance in Inspra film-coated tablets is eplerenone. Each tablet contains 25 mg or
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 of the Inspra 25 mg and 50 mg film-coated tablets contains: hypromellose
(E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), yellow iron oxide (E172), red iron oxide (E172).
Description of the appearance of Inspra and contents of the pack
The Inspra 25 mg tablets are yellow, film-coated tablets, marked with “Pfizer” on one side and “NSR” and “25” on the other side.
The Inspra 50 mg tablets are yellow, film-coated tablets, marked with “Pfizer” on one side and “NSR” and “50” on the other side.
Inspra 25 mg and 50 mg film-coated tablets are available in opaque PVC/Al blisters containing 10, 20, 28, 30, 50, 90, 100 or 200 tablets, and in packs of 10x1, 20x1, 30x1, 50x1, 90x1, 100x1 or 200x1 (10 packs of 20x1) tablets in unit-dose divisible opaque PVC/Al blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milano
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 Member States 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 Member State under the name Inspra:
Czech Republic