Eplerenone medreg

Package leaflet: Information for the patient

Eplerenon Medreg, 25 mg, coated tablets
Eplerenon Medreg, 50 mg, coated tablets
Eplerenonum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Eplerenon Medreg is and what it is used for

Eplerenon Medreg 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. Increased levels of aldosterone may cause changes in the body
leading to heart failure.
Eplerenon Medreg is used in the treatment of heart failure to prevent its worsening and to reduce
the number of hospitalizations in cases of:

• recent myocardial infarction – in combination with other medicines used for heart failure, or
• persistent, mild symptoms despite previous treatment.

2. Important information before using Eplerenon Medreg

When not to use Eplerenon Medreg:

• if the patient is allergic to eplerenon or any of the other ingredients of this medicine (listed in section 6);
• if the patient has high blood potassium levels (hyperkalaemia);
• 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 Eplerenon Medreg, discuss this with your doctor, pharmacist, or
nurse.

• If the patient has kidney or liver disease (see also section "When not to use Eplerenon Medreg"),
• 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 transplanted organs).

Children and adolescents
The safety and efficacy of eplerenone in children and adolescents have not been established.
Eplerenon Medreg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 Eplerenon Medreg, 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 blood potassium levels.
• Angiotensin-converting enzyme (ACE) inhibitors in combination with angiotensin II receptor antagonists (AIIRAs), used to treat high blood pressure, heart conditions, and certain kidney diseases – these medicines may increase the risk of high blood potassium levels.
• Lithium (usually used to treat manic-depressive disorders, also known as bipolar disorders) – concomitant use of lithium with diuretics and ACE inhibitors (used to treat high blood pressure and heart conditions) has increased blood lithium levels, which may cause adverse effects such as loss of appetite, vision disturbances, feeling of fatigue, muscle weakness, and muscle tremors.
• Cyclosporine or tacrolimus (used to treat skin diseases such as psoriasis or eczema and to prevent rejection of transplanted organs) – these medicines may cause kidney function disturbances and thereby increase the risk of high blood potassium levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs – some painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation) – these medicines may cause kidney function disturbances and thereby increase the risk of high blood potassium levels.
• Trimethoprim (used to treat bacterial infections) – may increase the risk of high blood potassium levels.
• 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), antipsychotic medicines, also called 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 the diagnosis and treatment of adrenal cortex disorders) – may reduce the blood pressure-lowering effect of Eplerenon Medreg.
• Digoxin (used to treat heart conditions) – concomitant use with Eplerenon Medreg may increase digoxin blood levels.
• Warfarin (an anticoagulant) – caution is advised when using warfarin, as increased warfarin blood levels may interfere with the effect of Eplerenon Medreg 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 conditions and high blood pressure) – these medicines slow down the metabolism of Eplerenon Medreg, thereby prolonging its effect in the body.
• St. John's wort (a herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, in the treatment of epilepsy) may accelerate the metabolism of Eplerenon Medreg, thereby weakening its effect.

Eplerenon Medreg with food and drink
Eplerenon Medreg can 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 become
pregnant, she should consult her doctor or pharmacist before using this medicine. The effect of Eplerenon Medreg during pregnancy has not been evaluated in humans.
It is not known whether eplerenone passes into human milk. The patient should consult her doctor whether to stop breastfeeding or discontinue the use of the medicine.
Driving and operating machinery
Dizziness may occur after taking Eplerenon Medreg. In such a case, the patient should not drive or
operate machinery.
Eplerenon Medreg contains lactose monohydrate
If the patient has previously been diagnosed with an intolerance to certain sugars, contact the doctor before using this medicine.
Eplerenon Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to use Eplerenon Medreg

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Eplerenon Medreg tablets may be taken with or without food. The tablets should be swallowed whole
with a large amount of water.
Eplerenon Medreg is usually taken together with other medicines used for heart failure, such as
beta-blockers. The usual starting dose is one 25 mg tablet once daily. After approximately 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
Eplerenon Medreg, during the first week of treatment, one month after starting treatment, and
following any dose adjustment. Depending on the blood potassium level, your doctor may adjust the
dose of the medicine.
If a patient has mild kidney disease, treatment should be initiated with one 25 mg tablet once daily.
If a patient has moderate kidney disease, treatment should be initiated with one 25 mg tablet every
other day. Your doctor may recommend adjusting the dose based on blood potassium levels.
Eplerenon Medreg 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.
However, in case of liver or kidney disease, more frequent monitoring of blood potassium levels may
be required (see also "When not to take Eplerenon Medreg").
Elderly patients: no adjustment of the initial dose is required.
Children and adolescents: Eplerenon Medreg is not recommended for use in children and adolescents.

Taking more Eplerenon Medreg than recommended
If you take more Eplerenon Medreg than recommended, 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 hyperkalaemia (high blood potassium levels),
which may cause muscle cramps, diarrhoea, nausea, dizziness or headache.

If you forget to take Eplerenon Medreg
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 more than 12 hours remain
before the next scheduled dose. Then continue with your regular dosing schedule.
Do not take a double dose to make up for a missed dose.

Stopping Eplerenon Medreg
It is important to take Eplerenon Medreg exactly as prescribed, unless your doctor advises you to
stop.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, 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;
• hives and breathing difficulties. These are symptoms of angioedema, an uncommon adverse reaction (may occur in less than 1 in 100 people).

Other reported adverse reactions include:
Common adverse reactions (may occur in less than 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 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;
• fatigue;
• muscle cramps;
• increased blood urea levels;
• increased blood creatinine levels, which may indicate impaired kidney function.

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

• infection;
• eosinophilia (increase in one type of white blood cells);
• low blood sodium levels;
• dehydration;
• increased blood triglyceride (fat) levels;
• rapid heart rate;
• cholecystitis (inflammation of the gallbladder);
• decreased blood pressure, which may cause dizziness upon changing to an upright position;
• 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 men;
• changes in certain blood test results.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions helps to provide more information on the safety of this medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Eplerenon Medreg

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 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 will help protect the environment.

6. Contents of the pack and other information

What Eplerenon Medreg contains
The active substance in Eplerenon Medreg is eplerenone.

• Each tablet contains 25 mg or 50 mg of eplerenone.

The other ingredients are:
Tablet core:
Monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate,
hypromellose (5 mPas), talc, and magnesium stearate.
Tablet coating:
Opadry 13B58802 (White): HPMC 2910/hypromellose (6 mPas), titanium dioxide (E 171), macrogol
400, polysorbate 80.
What Eplerenon Medreg looks like and contents of the pack

• Eplerenon Medreg 25 mg, coated tablets: White, biconvex, diamond-shaped coated tablet (length 7.22 mm, width 6.55 mm, thickness 2.80 mm), embossed with "E" on one side and "25" on the other side.
• Eplerenon Medreg 50 mg, coated tablets: White, biconvex, diamond-shaped coated tablet (length 9.28 mm, width 8.26 mm, thickness 3.65 mm), embossed with "E" on one side and "50" on the other side.

Eplerenon Medreg 25 mg, coated tablets and Eplerenon Medreg 50 mg, coated tablets
are available in blisters made of Aluminium/Paper/Polyester/PVC or blisters made of
PVC/PVDC/Aluminium, packed in a cardboard box.
Pack sizes: 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 200 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199
Importer:
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic: Eplerenon Medreg
Poland: Eplerenon Medreg
Slovakia: Eplerenon Medreg 25 mg
Eplerenon Medreg 50 mg