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LEDAPLER 25 MG FILM-COATED TABLETS

Active substance(s): EPLERENONE / EPLERENONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ledapler 25 mg film-coated tablets
Ledapler 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 Ledapler is and what it is used for
2.
What you need to know before you take Ledapler
3.
How to take Ledapler
4.
Possible side effects
5.
How to store Ledapler
6.
Contents of the pack and other information

1.

What Ledapler is and what it is used for

Ledapler 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.
Ledapler are 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 Ledapler

Do not take Ledapler

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 (hyperkalemia)

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.

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Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Ledapler

if you have kidney or liver disease (see also "Do not take Ledapler")

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 efficiacy of eplerenone in children and adolescents have not been established.
Other medicines and Ledapler
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
You must not take Ledapler with the following medications (see section "Do not take Ledapler"):





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 break-down of Ledapler, 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.

Please inform your doctor if you are taking any of the following medicines:
















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.
Cyclosporin 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 Ledapler.
Digoxin (used in the treatment of heart conditions). Digoxin blood levels may be increased
when taken together with Ledapler.
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 Ledapler 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
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treatment of heart problems and high blood pressure) reduce the break-down of Ledapler
thereby prolonging the effect of Ledapler 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 Ledapler and thus decrease its effect.

Ledapler with food and drink
Ledapler 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 Ledapler 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 breast-feeding or to discontinue the drug.
Driving and using machines
You may feel dizzy after taking Ledapler. If this should happen, do not drive or operate machinery.
Ledapler contain lactose One of the ingredients of Ledapler is lactose monohydrate (a type of sugar).
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 Ledapler

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Ledapler tablets may be taken together with food or on an empty stomach. Swallow the tablets whole
with plenty of water.
Ledapler is usually administered together with other medication for heart failure eg 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 Ledapler 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.
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 Ledapler 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 Ledapler").
For the elderly: no adjustment of the starting dose is required.

For children and adolescents: Ledapler is not recommended.
If you take more Ledapler than you should
If you take more Ledapler 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
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hyperkalemia, high levels of potassium in the blood (expressed by muscle cramps, diarrhoea, nausea,
dizziness or headache).
If you forget to take Ledapler
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 the forgotten tablet.
If you stop taking Ledapler
It is important to keep taking Ledapler 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:
You should seek immediate medical attention

swollen face, tongue or throat

difficulty swallowing

hives and difficulties breathing
These are the symptoms of angioneurotic oedema, an uncommon (affecting up to 1 in100 people)
side effect.

Other reported side effects include:
Common side-effects (may affect up to 1 in 10 people):

elevated potassium level in your blood (symptoms include muscle cramps, diarrhoea, nausea,
dizziness or headache)

dizziness

fainting

infection

elevated quantity of cholesterol in your blood

insomnia (difficult sleeping)

headache

heart complaints e-g-, irregular heartbeat and heart failure

cough

constipation

low blood pressure

diarrhoea

nausea

vomiting

abnormal functioning of your kidney

rash

itching

back pain

feeling weak

muscle spasm
04




increased urea level in the blood
increased creatinine blood levels 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

elevated quantity of triglycerides (fats) in your blood

low sodium blood levels

fast heart beat

inflammation of the gall bladder

decreased blood pressure that can cause dizziness upon standing

thrombosis (blood clot) in the leg

sore throat

flatulence

underactive thyroid

increase in blood glucose

reduced sense of touch

increased sweating

musculokeletal pain

feeling generally unwell

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 side effects not listed
in this leaflet. You can also report side effects directly via 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 Ledapler

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 pack and blister after {EXP}. The
expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 Ledapler contains
The active substance is eplerenone.
Each film-coated tablet contains 25 mg of eplerenone.
Each film-coated tablet contains 50 mg of eplerenone.

The other excipients are:
Tablet core:
Lactose monohydrate,
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Cellulose, microcrystalline (type 101),
Croscarmellose sodium,
Hypromellose (type 2910),
Cellulose, microcrystalline (type 102),
Sodium laurilsulfate,
Talc,
Magnesium stearate
Tablet coating:
Opadry II white OY-L-28900 containing:
- Lactose monohydrate,
- Hypromellose (type 2910),
- Titanium dioxide (E171),
- Macrogol 4000
What Ledapler looks like and contents of the pack
Film-coated tablet
The Ledapler 25 mg tablet is a white or almost white, round, biconvex film-coated tablet.
Engraving on one side: “CG3”, other side is without engraving.
The Ledapler 50 mg tablet is a white or almost white, round, biconvex film-coated tablet.
Engraving on one side: “CG4”, other side is without engraving.
Ledapler 25 mg and 50 mg film-coated are available in white opaque PVC/aluminium blister packs
containing 10, 20, 30, 50, 90 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Liconsa, S.A.
Gran Vía Carlos III, 98 – 7th
08028 Barcelona
Spain
Manufacturer
Laboratorios Liconsa, S.A.
Avenida Miralcampo 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

This leaflet was last revised in
July 2016

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Expand Transcript

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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