Eplenocard

Package leaflet: Information for the patient

Eplenocard, 25 mg, coated tablets
Eplenocard, 50 mg, coated tablets
(Eplerenone)
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet for possible future reference.
• 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. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Leaflet contents:

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

1. What Eplenocard is and what it is used for

Eplenocard belongs to a group of medicines called 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.
Eplenocard is used in the treatment of heart failure to prevent disease progression and reduce the number of hospitalizations in the following cases:

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

2. Important information before using Eplenocard

When not to use Eplenocard:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has high potassium levels in the blood (hyperkalemia)
• if the patient is taking diuretics that conserve potassium (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 (clarithromycin or telithromycin)
• if the patient is taking nefazodone, used to treat depression
• if the patient is simultaneously taking medicines used to treat certain heart conditions or high blood pressure (so-called angiotensin-converting enzyme inhibitors - ACE inhibitors - in combination with angiotensin receptor blockers - ARBs).

Warnings and precautions
Before starting treatment with Eplenocard, discuss with your doctor or pharmacist:

• if the patient has kidney or liver disease (see also section "When not to use Eplenocard")
• 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 disorders such as psoriasis or eczema, and to prevent organ transplant rejection).

Children and adolescents
Studies on the safety and efficacy of Eplenocard in children and adolescents have not been conducted.

Eplenocard and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription.
Do not take Eplenocard together with the following medicines (see section "When not to use Eplenocard"):

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for HIV), clarithromycin, telithromycin (used to treat bacterial infections), and nefazodone (used to treat depression). These medicines prolong the half-life of Eplenocard, thereby extending its effect on the body.
• Potassium-sparing diuretics (medicines that help remove excess fluid from the body) and potassium supplements. These medicines increase potassium levels in the blood.
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) when used together (used to treat high blood pressure, heart disease, and certain kidney diseases), because these medicines may increase potassium levels in the blood.

Inform your doctor if the patient is taking any of the following medicines:

• Lithium (usually used to treat manic-depressive disorders, also known as bipolar disorders). Taking lithium together with diuretics and angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure and heart disease) may increase lithium levels in the blood, potentially causing adverse effects such as loss of appetite, vision disturbances, fatigue, muscle weakness, and muscle tremors.
• Cyclosporine or tacrolimus (used to treat skin disorders such as psoriasis or eczema, and to prevent organ transplant rejection). These medicines may cause kidney dysfunction and thereby increase potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs - painkillers such as ibuprofen, used to reduce pain, stiffness, and inflammation). These medicines may lead to kidney dysfunction and thereby increase potassium levels in the blood.
• Trimethoprim (used to treat bacterial infections) may increase potassium levels in the blood.
• Alpha-1-adrenergic blockers, 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); antipsychotic medicines (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 (mainly used in diagnosing and treating adrenal cortex disorders), may reduce the blood pressure-lowering effect of Eplenocard.
• Digoxin (used to treat heart conditions). Concomitant use with Eplenocard increases digoxin blood levels.
• Warfarin (an anticoagulant): caution is required when warfarin is administered, as increased warfarin blood levels may interfere with the effect of Eplenocard on the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine used to treat HIV infection), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart conditions and high blood pressure) prolong the half-life of Eplenocard, thereby extending its effect on the body.
• St. John's wort (a herbal remedy), rifampicin (an antibiotic used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, in epilepsy treatment) may shorten the half-life of Eplenocard, thereby weakening its effect.

Eplenocard with food and drink
Eplenocard may be taken regardless of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Studies on the use of Eplenocard in pregnant women have not been conducted.
It is not known whether eplerenone passes into human milk. Consult the treating physician whether to discontinue breastfeeding or to stop using the medicine.

Driving and operating machinery
Dizziness may occur after taking Eplenocard. In such a case, driving vehicles or operating machinery should be avoided.

Eplenocard contains lactose monohydrate
Eplenocard contains lactose monohydrate (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Eplenocard contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Eplenocard

This medicine should always be taken as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Eplenocard tablets may be taken with or without food. The tablets should be swallowed whole,
with a large amount of water.
Eplenocard is usually taken together with other medicines used in heart failure, such as
beta-blockers. The usual starting dose is one 25 mg tablet once daily. The dose is increased after
approximately 4 weeks to 50 mg once daily (either as one 50 mg tablet or two 25 mg tablets).
The maximum dose is 50 mg per day.
Before starting treatment with Eplenocard, during the first week, and one month after starting
treatment or after a dose change, blood potassium levels should be measured. The physician may
adjust the dose depending on the blood potassium concentration.

Patients with impaired kidney or liver function
In patients with mild impairment of kidney function, treatment should be initiated with a single
25 mg dose once daily. In patients with moderate kidney disease, the initial dose is 25 mg every
other day. If recommended by the physician, and depending on blood potassium levels, these
doses may be adjusted accordingly.
Eplenocard is not recommended in patients with severe kidney disease.
In patients with mild to moderate liver impairment, no adjustment of the initial dose is required.
In patients with kidney or liver disease, more frequent monitoring of blood potassium levels may
be necessary (see also "When not to use Eplenocard").

Elderly patients
No adjustment of the initial dose is required.

Use in children and adolescents
Children and adolescents: Eplenocard is not recommended.

Taking more Eplenocard than recommended
If more Eplenocard has been taken than recommended, contact a physician or pharmacist
immediately. The most likely symptoms in case of overdose are: low blood pressure (causing
dizziness, blurred vision, weakness, sudden loss of consciousness) and hyperkalaemia, increased
blood potassium levels (causing muscle cramps, diarrhoea, nausea, dizziness or headache).

If a dose of Eplenocard is missed
If it is almost time for the next dose, skip the missed dose and take the next tablet at the
scheduled time.
Otherwise, take the tablet as soon as remembered, provided that more than 12 hours remain
before the next scheduled dose. Then continue taking the medicine as before.
Do not take a double dose to make up for a missed tablet.

Stopping Eplenocard
It is important to take Eplenocard as directed, unless the physician advises stopping treatment.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Seek immediate medical help
if any of the following symptoms occur:

• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria (hives) and breathing difficulties. These are symptoms of angioedema, which occurs not frequently (in less than 1 in 100 patients).

Other reported adverse reactions include:
Common adverse reactions (may occur in less than 1 in 10 patients):

• increased potassium levels in the blood (symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache)
• fainting
• dizziness
• heart-related problems, e.g. irregular heartbeat and heart failure
• cough
• constipation
• low blood pressure
• diarrhoea
• nausea
• vomiting
• kidney function abnormalities
• rash
• itching
• back pain
• fatigue
• muscle cramps
• increased blood urea levels
• increased creatinine levels in the blood, which may indicate impaired kidney function

Uncommon adverse reactions (may occur in less than 1 in 100 patients):

• infections
• eosinophilia (increase in one type of white blood cells)
• low sodium levels in the blood
• dehydration
• increased triglyceride (fat) levels in the blood
• rapid heartbeat
• inflammation of the gallbladder
• decreased blood pressure which may cause dizziness upon changing position to standing
• thrombosis (blood clots) in the lower limbs
• sore throat
• bloating
• hypothyroidism
• increased glucose levels in the blood
• reduced sensitivity to touch
• excessive sweating
• musculoskeletal pain
• general malaise
• kidney inflammation
• breast enlargement in men
• changes in blood test results

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Eplenocard

Keep this medicine out of the sight and reach of children.
There are no special requirements for storage of this medicinal product.
Do not use this medicine after the expiry date stated on the carton and blister after:
Expiry date (EXP). The expiry date (EXP) 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Eplenocard contains

• The active substance in Eplenocard coated tablets is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose (E460), hypromellose (Benecel E3), sodium croscarmellose (type A), talc, magnesium stearate.

The coating of Eplenocard 25 mg and 50 mg coated tablets contains Opadry 02F220004 (yellow):
polyethylene glycol/PEG 6000, HPMC 2910/hypromellose 5 cP, talc (E553b), titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).

What Eplenocard looks like and contents of the pack

Eplenocard 25 mg tablets are yellow, round, biconvex, film-coated tablets, embossed with "E25" on one side.
Eplenocard 50 mg tablets are yellow, round, biconvex, film-coated tablets, embossed with "E50" on one side.
Eplenocard 25 mg and 50 mg coated tablets are available in PVC/Aluminum blisters containing 20, 28, 30, 50, 90, 100 and 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer
Pharmathen S.A.
6, Dervenakion str.
153 51 Pallini, Attiki
Greece
Pharmathen International SA
Sapes Industrial Park Block 5
69300 Rodopi
Greece
G.L.Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria