Eplerenone Accord

PATIENT INFORMATION LEAFLET

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

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Eplerenone Accord belongs to a class of medicines known as selective aldosterone blockers.
These blockers 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 Accord is used to treat your 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 need to know before taking Eplerenone Accord

Do not take Eplerenone Accord

• 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 disease
• if you have severe liver disease
• if you are taking medicines used to treat fungal infections (ketoconazole and itraconazolo)
• 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 certain heart conditions or high blood pressure (called angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs)) at the same time

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Eplerenone Accord

• if you have kidney or liver disease (see also “Do not take Eplerenone Accord”)
• if you are taking lithium (commonly used for manic-depressive disorder, also known as bipolar disorder)
• if you are taking tacrolimus or ciclosporin (used to treat skin conditions such as psoriasis or eczema and to prevent organ transplant rejection)

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
The safety and efficacy of eplerenone in children and adolescents have not been established.
Other medicines and Eplerenone Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines for the treatment of HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the elimination of Eplerenone Accord, 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) together with angiotensin receptor blockers (ARBs) (used to treat high blood pressure, heart diseases, or certain kidney conditions), because these medicines may increase the risk of high potassium levels in the blood.

• Lithium (commonly used for manic-depressive disorder, also known as bipolar disorder). It has been shown that using lithium together with diuretics and ACE inhibitors (used to treat high blood pressure and heart disorders) may cause excessive increases in lithium levels in the blood, which can lead to the following adverse effects: loss of appetite, blurred vision, fatigue, 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 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 the treatment of depression), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (for the treatment of psychiatric disorders), amifostine (used in cancer chemotherapy), and baclofen (used to treat muscle spasms). These medicines may cause drops 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 the diagnosis and treatment of adrenal cortex disorders), may reduce blood pressure, decreasing the effect of Eplerenone Accord.

• Digoxin (used to treat heart disorders). Digoxin levels in the blood may increase when administered together with Eplerenone Accord.

• Warfarin (an anticoagulant medicine): caution is recommended when taking warfarin, as high levels of warfarin in the blood may alter the effects of Eplerenone Accord in the body.

• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for the treatment of HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for the treatment of heart disorders and high blood pressure) reduce the elimination of Eplerenone Accord, prolonging its effect in the body.

• 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 Eplerenone Accord and thus reduce its effects.

Eplerenone Accord with food and drink
Eplerenone Accord can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. The effect of Eplerenone Accord during pregnancy has not been evaluated.
It is not known whether eplerenone is excreted in breast milk. Together with your doctor, you must decide whether to stop breastfeeding or to stop taking the medicine.
Driving and using machines
After taking Eplerenone Accord, you may experience dizziness. If this occurs, do not drive or operate machinery.
Eplerenone Accord contains lactose monohydrate
Eplerenone Accord contains lactose monohydrate (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Eplerenone Accord

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Eplerenone Accord tablets can be taken with or without food. Swallow the tablets whole with a full glass of water.
Eplerenone Accord 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 then increased after 4 weeks to 50 mg once daily (one 50 mg tablet or two 25 mg tablets). The maximum dose is 50 mg per day.
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Your blood potassium levels should be measured before starting treatment with Eplerenone Accord, within the first week, and within the first month of treatment or after any dose adjustment. Your doctor may adjust your dose based on your blood potassium levels.
If you have mild kidney disease, treatment should be started with one 25 mg tablet once daily. If you have moderate kidney disease, treatment should be started with one 25 mg tablet every other day. Based on your doctor’s recommendation and your blood potassium levels, these doses may be adjusted.
Eplerenone Accord is not recommended in patients with severe kidney disease.
In patients with mild to moderate liver function 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 Eplerenone Accord").
For elderly patients: no initial dose adjustment is required.
For children and adolescents: Eplerenone Accord is not recommended.
If you take more Eplerenone Accord than you should
If you have taken more Eplerenone Accord tablets than prescribed, contact your doctor or pharmacist immediately.
If you have taken too many tablets, the most likely symptoms are low blood pressure (dizziness, lightheadedness, blurred vision, weakness, sudden loss of consciousness) or hyperkalaemia (high potassium levels in the blood), which may cause muscle cramps, diarrhoea, nausea, dizziness, or headache.
If you forget to take Eplerenone Accord
If it is almost time for your next dose, skip the missed dose and take the next tablet at the usual time.
Otherwise, take it as soon as you remember, provided that at least 12 hours will pass 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 Accord
It is important to continue taking Eplerenone Accord as prescribed unless your doctor tells you to stop.
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 symptoms:
Contact 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 (affects up to 1 in 100 people).
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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)
• dizziness
• fainting
• high cholesterol levels in the blood
• insomnia (difficulty sleeping)
• headache
• heart problems, e.g. irregular heartbeat and 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 side effects (may affect up to 1 in 100 people):

• infection
• eosinophilia (increase in certain white blood cells)
• dehydration
• increased levels of cholesterol or triglycerides (fats) in the blood
• low levels of sodium in the blood
• rapid heartbeat
• inflammation of the gallbladder
• decreased blood pressure which may cause dizziness when standing up
• thrombosis (blood clots) in the legs
• inflamed 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 experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website:
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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 Eplerenone Accord

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 packaging and on the 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 Eplerenone Accord contains
The active substance in Eplerenone Accord film-coated tablets is eplerenone. Each tablet contains 25 mg or 50 mg of eplerenone.
The other components are: Monohydrate lactose, microcrystalline cellulose, hypromellose, sodium croscarmellose, talc and magnesium stearate.
The yellow Opadry 13B52001 coating of Eplerenone Accord contains:
Hypromellose, titanium dioxide (E171), polyethylene glycol 400, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172).
Description of the appearance of Eplerenone Accord and package contents
Eplerenone Accord 25 mg is a yellow, biconvex, diamond-shaped, film-coated tablet, marked with "E1" on one side and smooth on the other. The length, width and thickness of the film-coated tablet are 7.20 ± 0.3 mm, 6.40 ± 0.3 mm and 3.15 ± 0.3 mm, respectively.
Eplerenone Accord 50 mg is a yellow, biconvex, diamond-shaped, film-coated tablet, marked with "E2" on one side and smooth on the other. The length, width and thickness of the film-coated tablet are 9.00 ± 0.3 mm, 8.10 ± 0.3 mm and 4.25 ± 0.3 mm, respectively.
Eplerenone Accord 25 mg and 50 mg film-coated tablets are available in blisters containing 10, 28, 30, 90 or 100 tablets, or in perforated unit dose blisters containing 10x1, 28x1, 30x1, 90x1 or 100x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
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Accord Healthcare Limited
Sage House, 319
Pinner Road, Harrow,
Middlesex, HA1 4HF
United Kingdom
Wessling Hungary Kft.
Fóti út 56, 1047 Budapest,
Hungary
This medicinal product is authorised in the European Economic Area Member States:
Country Name of the medicinal product

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