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EPLERENONE 50 MG FILM-COATED TABLETS

Active substance(s): EPLERENONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Eplerenone 25 mg and 50 mg film-coated tablets
eplerenone
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.

What is in this leaflet:
1. What Eplerenone tablets are and what they are used for
2. What you need to know before you take Eplerenone
tablets
3. How to take Eplerenone tablets
4. Possible side effects
5. How to store Eplerenone tablets
6. Contents of the pack and other information

1. WHAT EPLERENONE TABLETS ARE AND
WHAT THEY ARE USED FOR
Eplerenone tablets contains the active substance
eplerenone. Eplerenone belongs to a group of medicines
known as selective aldosterone blocking agents. These
blocking agents inhibit the action of aldosterone, a
substance produced within the body, which controls
your blood pressure and heart function. High levels of
aldosterone can cause changes in your body that lead to
heart failure.
Eplerenone is used to treat your heart failure to prevent
worsening and reduce hospitalisations if you have:
1. had a recent heart attack, in combination with other
drugs that are used to treat your heart failure, or
2. have persistent, mild symptoms despite the treatment
you have been receiving so far.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE EPLERENONE TABLETS
Do not take Eplerenone tablets
• if you are allergic to eplerenone or 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 groups of drugs which help you
to excrete excessive body fluid, (potassium sparing
diuretics) or “salt tablets” (potassium supplements).
• if you have severe kidney disease.
• if you have severe liver disease.
• if you are taking medicines that are used to treat
fungal infection (ketoconazole or itraconazole).
• if you are taking antiviral medication for treating HIV
(nelfinavir or ritonavir).
• if you are taking antibiotics used to treat bacterial
infections (clarithromycin or telithromycin).
• if you are taking nefazodone used to treat depression.
• if you are taking medicines used to treat certain heart
conditions or hypertension (so called angiotensin
converting enzyme (ACE) inhibitor and an angiotensin
receptor blocker (ARB)) together.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Eplerenone tablets
• if you have kidney or liver disease (see also “Do not
take Eplerenone tablets”).
• if you are taking lithium (usually given for manic
depressive disorder, also called bipolar disorder).
• if you are taking tacrolimus or cyclosporin (used to
treat skin conditions such as psoriasis or eczema, and
to prevent rejection after organ transplantation).
Children and adolescents
The safety and efficacy of eplerenone in children and
adolescents have not been established.
Other medicines and Eplerenone tablets
You must not take eplerenone with the following
medications (see section “Do not take Eplerenone
tablets”):
• Itraconazole or ketoconazole (used to treat fungal
infections), ritonavir, nelfinavir (antiviral medication
for treating HIV), clarithromycin, telithromycin (used
to treat bacterial infections) or nefazodone (used to
treat depression) as these drugs reduce the breakdown of eplerenone, thereby prolonging its effect on
the body.
• Potassium sparing diuretics (drugs which help
you to excrete excess body fluid) and potassium
supplements (salt tablets) as these drugs increase
the risk of high potassium levels in your blood.
• Angiotensin converting enzyme (ACE) inhibitors
and angiotensin receptor blockers (ARB) together
(which are used to treat high blood pressure, heart

disease or particular kidney conditions) as these
drugs may increase the risk of high potassium levels
in your blood.
Eplerenone can interact with:
• Lithium (usually given for manic depressive disorder,
also called bipolar disorder). Use of lithium together
with diuretics and ACE inhibitors (used to treat high
blood pressure and heart disease) has been shown
to cause levels of lithium in the blood to become too
high, which may cause side effects of: loss of appetite;
visual impairment; tiredness; muscle weakness;
muscle twitches.
• Ciclosporin or tacrolimus (used to treat skin
conditions such as psoriasis or eczema, and to prevent
rejection after organ transplantation). These drugs can
cause kidney problems and therefore increase the risk
of high potassium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs certain pain killers such as ibuprofen, used to relieve
pain, stiffness and inflammation). These drugs may
lead to kidney problems and therefore increase the risk
of high potassium levels in your blood.
• Trimethoprim (used to treat bacterial infections) may
increase the risk of high potassium levels in your blood.
• Alpha I blockers (such as prazosin or alfuzosin) (used
to treat high blood pressure and particular prostate
conditions) may lead to a fall in blood pressure and
dizziness upon standing.
• Tricyclic antidepressants (such as amitryptyline
or amoxapine) (for treatment of depressions),
antipsychotics (also known as neuroleptics) (such
as chlorpromazine or haloperidol) (for the treatment
of psychiatric disorders), amifostine (used during
cancer chemotherapy) and baclofen (used to treat
muscle spasm). These drugs may lead to a fall in blood
pressure and dizziness upon standing.
• Glucocorticoids (such as hydrocortisone or
prednisone) (used to treat inflammation and certain
skin conditions) and tetracosactide (mainly used for
diagnosing and treating disorders of the adrenal cortex)
may reduce the blood-pressure lowering effect of
eplerenone.
• Digoxin (used in the treatment of heart conditions).
Digoxin blood levels may be increased when taken
together with eplerenone.
• Warfarin (an anti-clotting drug): Caution is warranted
when taking warfarin because high levels of warfarin
in the blood may cause changes in the effect of
Eplerenone on the body.
• Erythromycin (used to treat bacterial infections),
saquinavir (antiviral medication for treating HIV),
fluconazole (used to treat fungal infections),
amiodarone, diltiazem and verapamil (for the
treatment of heart problems and high blood pressure)
reduce the break-down of eplerenone thereby
prolonging the effect of eplerenone on the body.
• St John’s Wort (herbal medicinal product), rifampicin
(used to treat bacterial infections), carbamazepine,
phenytoin, and phenobarbital (used, among others,
to treat epilepsy) may increase the break-down of
eplerenone and thus decrease its effect.
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Eplerenone tablets with food and drink
Eplerenone may be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
The effect of eplerenone has not been evaluated during
pregnancy in humans. It is not known if eplerenone is
excreted in human breast milk. A decision should be
made with your doctor, whether to discontinue breastfeeding or to discontinue the drug.
Driving and using machines
You may feel dizzy after taking eplerenone. If this should
happen, do not drive or operate machinery.
Eplerenone tablets contain lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

3. HOW TO TAKE EPLERENONE TABLETS



Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.



Eplerenone tablets may be taken together with food or on
an empty stomach. Swallow the tablets whole with plenty
of water.










Eplerenone is usually administered together with other
medication for heart failure e.g. beta blockers. The
usual starting dose is one 25 mg tablet once daily,
increasing after about 4 weeks to 50 mg once daily
(either as one 50 mg tablet or two 25 mg tablets). The
maximum dose regimen is 50 mg daily.









Blood potassium levels should be measured before
starting eplerenone therapy, within the first week and at
one month after the start of treatment or after a change
in dose. The dose may be adjusted by your doctor,
depending on the potassium levels in your blood.
Patients with kidney or liver disease
If you have mild kidney disease, you should start on one
25 mg tablet every day. And if you have moderate kidney
disease, you should start on one 25 mg tablet every
other day. These doses may be adjusted if your doctor
recommends and according to your blood potassium
levels. In patients with severe kidney disease, eplerenone
is not recommended.
In patients with mild-to-moderate liver disease no
adjustment of the starting dose is required. If you have
liver or kidney problems, you may need more frequent
testing of your blood potassium levels (see also “Do not
take Eplerenone tablets”).
Older people
No adjustment of the starting dose is required.
Use in children and adolescents
Eplerenone is not recommended.
If you take more Eplerenone tablets than you
should
If you take more eplerenone than you should, tell your
doctor or pharmacist immediately. If you have taken too
much of your medicine, the most likely symptoms will be
low blood pressure (expressed as a light feeling in your
head, dizziness, blurred vision, weakness, acute loss of
consciousness) or hyperkalemia, high levels of potassium
in the blood (expressed by muscle cramps, diarrhoea,
nausea, dizziness or headache).
If you forget to take Eplerenone tablets
If it is almost time for your next tablet, skip the tablet you
missed and take your next tablet when it is due.
Otherwise take the tablet as soon as you remember,
providing there is more than 12 hours to when you are
due to take your next tablet. Then go back to taking your
medicine as you would normally.
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Eplerenone tablets
It is important to keep taking eplerenone as prescribed
unless your doctor tells you to stop your treatment.
If you have any further questions on the use of 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 stop taking the
medication and seek the doctor immediately:
• swollen face, tongue or throat
• difficulty swallowing
• hives and difficulties breathing
These are the symptoms of angioneurotic oedema.
Other reported side effects include:
Common: (may affect up to 1 in 10 people)
• Heart attack
• elevated potassium level in your blood (symptoms
include muscle cramps, diarrhoea, nausea, dizziness or
headache)
• dizziness
• fainting
• infection
• cough
• constipation
• low blood pressure
• diarrhoea
• nausea
• rash
• abnormal functioning of your kidney
• itching
• muscle spasm and pain
• increased urea level in the blood
Uncommon: (may affect up to 1 in 100 people)
• Increase in certain white blood cells (eosinophilia)
• dehydration, elevated quantity of cholesterol or
triglycerides (fats) in your blood





low sodium blood levels
difficulty sleeping (insomnia)
headache
heart complaints e.g. irregular heart beat, fast heart
beat, and heart failure
inflammation of the gall bladder
decreased blood pressure that can cause dizziness
upon standing
thrombosis (blood clot) in the leg
sore throat
flatulence
vomiting
underactive thyroid
increase in blood glucose
reduced sense of touch
increased sweating
back pain, feeling weak and generally unwell
increased urea and creatinine blood levels which may
indicate kidney problems, kidney inflammation
enlargement of breasts in men
changes in some blood test results

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.
uk/yellowcard.By reporting side effects you can help
provide more information on the safety of this medicine.

5. HOW TO STORE EPLERENONE TABLETS
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special
storage conditions.
Do not use this medicine after the expiry date which is
stated on the blister and carton after ‘EXP’. The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Eplerenone tablets contain
• The active substance is eplerenone. Each tablet
contains 25 mg or 50 mg eplerenone.
• The other ingredients are lactose monohydrate,
cellulose microcrystalline (E460), croscarmellose
sodium (E468), hypromellose (E464), sodium
laurilsulfate, talc (E553b), magnesium stearate (tablet
core); hypromellose (E464), polysorbate 80 (E433),
macrogol 400, titanium dioxide (E171), iron oxide
yellow (E172) (tablet coating).
What Eplerenone tablets look like and contents
of the pack
Eplerenone 25 mg is a light yellow, round (approximately
6 mm), biconvex film-coated tablet, debossed with ‘E9RN’
on one side and ‘25’ on the other side.
Eplerenone 50 mg is a light yellow, round (approximately
8 mm), biconvex film-coated tablet, debossed with ‘E9RN’
on one side and ‘50’ on the other side.
Eplerenone tablets are available in blister packs of 10, 14,
20, 28, 30, 50, 56, 60, 84, 90, 98 or 100 tablets; unit dose
of 10x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60
x 1, 84 x 1, 90 x 1, 98 x 1 or 100 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Manufacturer(s):
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania S.L.
C/ Castelló 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain
Distributed by:
Consilient Health (UK) Ltd.,
No.1 Church Road,
Richmond upon Thames,
Surrey. TW9 2QE.
This leaflet was last revised in March 2015.

P0342

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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