Eplerenone Krka

Package leaflet: Information for the patient

Eplerenone Krka 25 mg film-coated tablets, 50 mg film-coated tablets

eplerenone
Equivalent medicine
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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Eplerenone Krka is and what it is used for

Eplerenone Krka 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 heart function. Elevated levels of aldosterone can cause changes in the body that lead to heart failure. Eplerenone Krka is used to treat heart failure, to prevent its worsening, and to reduce hospitalisation if:

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

2. What you should know before taking Eplerenone Krka

Do not take Eplerenone Krka

• 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 (hyperkalaemia).
• if you are taking medicines that help eliminate excess body fluids (potassium-sparing diuretics).
• if you have severe kidney problems.
• if you have severe liver problems.
• if you are taking antifungal medicines (ketoconazole and 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 or pharmacist before taking Eplerenone Krka.

• if you have kidney or liver problems (see also “Do not take Eplerenone Krka”)
• if you are taking lithium (commonly used for manic-depressive disorders, also called bipolar disorders)
• if you are taking tacrolimus or ciclosporin (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 has not been established.
Other medicines and Eplerenone Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• itraconazole or ketoconazole (for treatment of fungal infections), ritonavir, nelfinavir (antiviral medicines for treatment of HIV), clarithromycin, telithromycin (used for treatment of bacterial infections), or nefazodone (for depression), as these medicines reduce the elimination of Eplerenone Krka, 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 may 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 side effects: loss of appetite, blurred vision, tiredness, muscle weakness, muscle cramps.
• ciclosporin or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent organ transplant rejection). These medicines may 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 may 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 chemotherapy), and baclofen (used to treat muscle spasms). These medicines may cause a drop in 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 blood pressure, decreasing the effect of Eplerenone Krka.
• digoxin (used in the treatment of heart conditions). Digoxin levels in the blood may increase when administered together with Eplerenone Krka.
• warfarin (an anticoagulant medicine): caution is recommended with warfarin, as high levels of warfarin in the blood may alter the effects of Eplerenone Krka.
• 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 Eplerenone Krka, prolonging its effect.
• St. John’s wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, for the treatment of epilepsy) may increase the elimination of Eplerenone Krka and thus reduce its effects.

Eplerenone Krka with food and drinks
Eplerenone Krka can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The effect of eplerenone has not been evaluated during pregnancy in humans.
It is not known whether eplerenone is excreted in breast milk. Together with your doctor, you must decide whether to discontinue breastfeeding or to stop taking the medicine.
Driving and using machines
After taking Eplerenone Krka, you may experience dizziness. If this occurs, do not drive or operate machinery.
Eplerenone Krka contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How to take Eplerenone Krka

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Eplerenone Krka tablets can be taken with or without food. Swallow the tablets whole with a sufficient amount of water.
Eplerenone Krka 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, increasing after 4 weeks to 50 mg once daily (one 50 mg tablet or two 25 mg tablets). The maximum daily dose is 50 mg.
Your blood potassium levels should be measured before starting treatment with Eplerenone Krka, 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 blood potassium levels.
If you have mild kidney problems, treatment should be started with one 25 mg tablet once daily. If you have moderate kidney problems, treatment should be started with one 25 mg tablet every other day. Depending on your blood potassium levels and as recommended by your doctor, these doses may be adjusted.
Eplerenone Krka is not recommended in patients with severe kidney problems.
In patients with mild to moderate liver problems, no adjustment of the initial dose is required.
If you have kidney or liver problems, you may need more frequent monitoring of your blood potassium levels (see also “Do not take Eplerenone Krka").
For elderly patients: no adjustment of the initial dose is required.
For children and adolescents: Eplerenone Krka is not recommended.
If you take more Eplerenone Krka than you should
If you take more Eplerenone Krka than prescribed, contact your doctor or pharmacist immediately. If you have taken too many tablets, the most likely symptoms are low blood pressure (feeling faint, dizziness, 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 Eplerenone Krka
If it is almost time for your next dose, skip the missed dose and take the next tablet at the scheduled 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 Eplerenone Krka
It is important that you take Eplerenone Krka as prescribed unless your doctor tells you to stop treatment.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following:
You must contact your doctor immediately

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

These are symptoms of angioedema, an uncommon side effect (affecting up to 1 in 100 people).
Other reported side effects include:
Common side effects (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
• High levels of cholesterol in the blood
• Insomnia (difficulty sleeping)
• Headache
• Heart problems, such as irregular heartbeat and heart failure
• Cough
• Constipation
• Low blood pressure
• Diarrhoea
• Nausea
• Vomiting
• Abnormal kidney function
• Skin rash
• Itching
• Back pain
• Feeling of weakness
• Muscle spasms
• Increased levels of urea in the blood
• Increased levels of creatinine in the blood, which may indicate kidney problems

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

• Infections
• Eosinophilia (increased number of certain white blood cells)
• Low levels of sodium in the blood
• Dehydration
• Increased levels of triglycerides (fat) in the blood
• Fast heartbeat
• Inflammation of the gallbladder
• Decreased blood pressure which may cause dizziness when standing up
• Blood clots (thrombosis) in the legs
• Inflamed throat
• Flatulence
• Reduced thyroid function
• Increased blood glucose levels
• Reduced sensitivity to touch
• Increased sweating
• Musculoskeletal pain
• Feeling of general malaise
• Kidney inflammation
• Breast enlargement in men
• Changes in the results of certain blood tests

Reporting of side effects
If you experience any side effect, 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eplerenone Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "Exp" and on the blister after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Eplerenone Krka contains

• The active substance is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.
• The other ingredients are monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate and sodium lauryl sulfate in the tablet core, and hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 and yellow iron oxide (E172) in the tablet coating. See section 2 “Eplerenone Krka contains lactose and sodium”.

Description of the appearance of Eplerenone Krka and contents of the pack
25 mg: yellow, film-coated, round, biconvex tablets marked with "25" on one side.
Size: diameter 6 mm.
50 mg: yellow, film-coated, round, biconvex tablets marked with "50" on one side.
Size: diameter 7.5 mm.
Eplerenone Krka is available in packs containing:

• 10, 20, 28, 30, 50, 90 and 100 film-coated tablets in blister packs.
• 10 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 90 x 1 and 100 x 1 film-coated tablets in single-dose perforated blister packs.

Not all pack sizes may be marketed.
Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Local representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italy
This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

More detailed information on this medicinal product is available on the AIFA website
(https://www.aifa.gov.it)