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EPLERENONE 25MG FLIM-COATED TABLETS

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Ref: LTT6869/171014/1/F

®

®

Inspra 25mg Film-Coated Tablets / Inspra 50mg Film-Coated Tablets
(Eplerenone)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important infromation 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.
Your medicine is called either Inspra 25mg Film-Coated Tablets or Inspra
50mg Film-Coated Tablets, throughout this leaflet it will be refered to as
Inspra
What is in this leaflet:
1

What Inspra is and what it is used for

2

What you need to know before you take Inspra

3

How to take Inspra

4

Possible side effects

5

How to store Inspra

6 Contents of the pack and other information

1

What Inspra is and what it is used for

Inspra 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.
Inspra 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 Inspra

Do not take Inspra
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.

*

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Inspra.
* if you have kidney or liver disease (see also “Do not take Inspra”)
* 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 Inspra
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
You must not take Inspra with the following medications (see section “Do not
take Inspra”):
* Itraconazole or ketoconazole (used to treat fungal infections), ritonavir,
nelfinavir (antiviral medication for treating HIV), clarithromycin, elithromycin
(used to treat bacterial infections) or nefazodone (used to treat
depression) as these drugs reduce the break-down of Inspra, 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 Inspra.
* Digoxin (used in the treatment of heart conditions). Digoxin blood levels
may be increased when taken together with Inspra.
* 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 Inspra 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 Inspra thereby
prolonging the effect of Inspra 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 Inspra
and thus decrease its effect.
Inspra with food and drink
Inspra 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 Inspra 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 Inspra. If this should happen, do not drive or
operate machinery.
Inspra contains lactose monohydrate
Inspra contains 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 Inspra

Always take this medicine exactly as your doctor or pharmacist has told you.
You should check with your doctor or pharmacist if you are not sure.
Inspra tablets may be taken together with food or on an empty stomach.
Swallow the tablets whole with plenty of water.
Inspra 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 Inspra 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.

Ref: LTT6869/171014/1/B

®

®

Inspra 25mg Film-Coated Tablets / Inspra 50mg Film-Coated Tablets
(Eplerenone)
Patient Information Leaflet (continued)
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, Inspra 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
Inspra”).
For the elderly: no adjustment of the starting dose is required.
For children and adolescents: Inspra is not recommended.
If you take more Inspra than you should
If you take more Inspra 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 Inspra
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 Inspra
It is important to keep taking Inspra 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.
Other reported side effects include:
Common side-effects (occurs between 1 and 10 out of every 100 patients):
* 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
* abnormal functioning of your kidney
* rash
* itching
* muscle spasm and pain
* increased urea level in the blood
Uncommon side-effects (occurs between 1 and 10 out of every 1,000
patients):
* eosinophilia (increase in certain white blood cells)
* dehydration
* elevated quantity of cholesterol or triglycerides (fats) in your blood
* low sodium blood levels
* insomnia (difficulty sleeping)
* 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 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, pharmacist or nurse. 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 Inspra

Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Inspra film-coated tablets after the expiry date stated on the pack
and blister. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Contents of the pack and other information

What Inspra contains
Each Inspra 25mg Film-Coated Tablet contains 25mg of eplerenone as the
active ingredient.
Each Inspra 50mg Film-Coated Tablet contains 50mg of eplerenone as the
active ingredient.
Inspra 25 mg and 50 mg film-coated tablets also contain the following
inactive ingredients: lactose monohydrate, microcrystalline cellulose,
croscarmellose sodium, hypromellose, sodium lauryl sulphate, talc and
magnesium stearate.
The opadry yellow coating of Inspra 25 mg and 50 mg film-coated tablets
contains hypromellose, titanium dioxide (E171), macrogol 400, polysorbate
80, yellow iron oxide (E172), red iron oxide (E172).
What Inspra looks like and contents of the pack
The Inspra 25 mg tablets are diamond shaped yellow tablets with “Pfizer” on
one side and “NSR” over “25” on the other.
The Inspra 50 mg tablets are diamond shaped yellow tablets with “Pfizer” on
one side and “NSR” over “50” on the other.
Inspra 25 mg and 50 mg film-coated tablet are available in blister packs
containing 20 or 30 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Pfizer PGM, Zone Industrielle-29 route
des Industries, 37530 Poce-sure-Cisse, France and is procured from within
the EU. Product Licence Holder: LTT Pharma Ltd, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by
Lexon (UK) Ltd, B98 0RE.

POM

PL 33723/0068 Inspra 25mg Film-Coated Tablets
PL 33723/0069 Inspra 50mg Film-Coated Tablets

Inspra is a registered trademark of Pfizer.
Revision date: 17/10/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: LTT6869/171014/2/F

Eplerenone 25mg Film-Coated Tablets / Eplerenone 50mg Film-Coated Tablets
Patient Information Leaflet
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.
Your medicine is called either Eplerenone 25mg Film-Coated Tablets or
Eplerenone 50mg Film-Coated Tablets, throughout this leaflet it will be
refered to as Eplerenone
What is in this leaflet:
1 What Eplerenone is and what it is used for
2 What you need to know before you take Eplerenone
3 How to take Eplerenone
4 Possible side effects
5 How to store Eplerenone
6 Contents of the pack and other information

1

What Eplerenone is and what it is used for

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

Do not take Eplerenone
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.

*

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Eplerenone.
* if you have kidney or liver disease (see also “Do not take Eplerenone”)
* 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
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
You must not take Inspra with the following medications (see section “Do not
take Eplerenone”):
* Itraconazole or ketoconazole (used to treat fungal infections), ritonavir,
nelfinavir (antiviral medication for treating HIV), clarithromycin, elithromycin
(used to treat bacterial infections) or nefazodone (used to treat
depression) as these drugs reduce the break-down 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.

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 Inspra.
* Digoxin (used in the treatment of heart conditions). Digoxin blood levels
may be increased when taken together with Inspra.
* 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 Inspra 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 Inspra thereby
prolonging the effect of Inspra 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 Inspra
and thus decrease its effect.
Eplerenone 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 Inspra 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 Inspra. If this should happen, do not drive or
operate machinery.
Eplerenone contains lactose monohydrate
Eplerenone contains 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 Eplerenone

Always take this medicine exactly as your doctor or pharmacist has told you.
You should 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 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 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.

Ref: LTT6869/171014/2/B

Eplerenone 25mg Film-Coated Tablets / Eplerenone 50mg Film-Coated Tablets
Patient Information Leaflet (continued)
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.

* increased creatinine blood levels which may indicate kidney problems
* kidney inflammation
* enlargement of breasts in men
* changes in some blood test results

In patients with severe kidney disease, Eplerenone is not recommended.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

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”).
For the elderly: no adjustment of the starting dose is required.
For children and adolescents: Eplerenone is not recommended.
If you take more Eplerenone 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
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 Eplerenone
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

5

How to store Eplerenone

Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Eplerenone film-coated tablets after the expiry date stated on the
pack and blister. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Contents of the pack and other information

Each Eplerenone 25mg Film-Coated Tablet contains 25mg of eplerenone as
the active ingredient.
Each Eplerenone 50mg Film-Coated Tablet contains 50mg of eplerenone as
the active ingredient.
Eplerenone 25 mg and 50 mg film-coated tablets also contain the following
inactive ingredients: lactose monohydrate, microcrystalline cellulose,
croscarmellose sodium, hypromellose, sodium lauryl sulphate, talc and
magnesium stearate.

Possible side effects

Like all medicines this medicine can cause side effects, although not
everybody gets them.

The opadry yellow coating of Eplerenone 25 mg and 50 mg film-coated
tablets contains hypromellose, titanium dioxide (E171), macrogol 400,
polysorbate 80, yellow iron oxide (E172), red iron oxide (E172).

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.

What Eplerenone looks like and contents of the pack
The Eplerenone 25 mg tablets are diamond shaped yellow tablets with
“Pfizer” on one side and “NSR” over “25” on the other.

Other reported side effects include:
Common side-effects (occurs between 1 and 10 out of every 100 patients):
* 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
* abnormal functioning of your kidney
* rash
* itching
* muscle spasm and pain
* increased urea level in the blood

Eplerenone 25 mg and 50 mg film-coated tablet are available in blister packs
containing 20 or 30 tablets.

Uncommon side-effects (occurs between 1 and 10 out of every 1,000
patients):
* eosinophilia (increase in certain white blood cells)
* dehydration
* elevated quantity of cholesterol or triglycerides (fats) in your blood
* low sodium blood levels
* insomnia (difficulty sleeping)
* 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

The Eplerenone 50 mg tablets are diamond shaped yellow tablets with
“Pfizer” on one side and “NSR” over “50” on the other.

Manufacturer and Licence Holder
This medicine is manufactured by Pfizer PGM, Zone Industrielle-29 route
des Industries, 37530 Poce-sure-Cisse, France and is procured from within
the EU. Product Licence Holder: LTT Pharma Ltd, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by
Lexon (UK) Ltd, B98 0RE.

POM

PL 33723/0068 Eplerenone 25mg Film-Coated Tablets
PL 33723/0069 Eplerenone 50mg Film-Coated Tablets

Revision date: 17/10/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: LTT6869/171014/3/F

®

®

Inspra 25mg Film-Coated Tablets / Inspra 50mg Film-Coated Tablets
(Eplerenone)
Patient Information Leaflet
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.
Your medicine is called either Inspra 25mg Film-Coated Tablets or Inspra
50mg Film-Coated Tablets, throughout this leaflet it will be refered to as
Inspra
What is in this leaflet:
1

What Inspra is and what it is used for

2

What you need to know before you take Inspra

3

How to take Inspra

4

Possible side effects

5

How to store Inspra

6

Contents of the pacl and other information

1

What Inspra is and what it is used for

Inspra 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.
Inspra 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 Inspra

Do not take Inspra
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.

*

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Inspra.
* if you have kidney or liver disease (see also “Do not take Inspra”)
* 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 Inspra
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
You must not take Inspra with the following medications (see section “Do not
take Inspra”):
* Itraconazole or ketoconazole (used to treat fungal infections), ritonavir,
nelfinavir (antiviral medication for treating HIV), clarithromycin, elithromycin
(used to treat bacterial infections) or nefazodone (used to treat
depression) as these drugs reduce the break-down of Inspra, 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 Inspra.
* Digoxin (used in the treatment of heart conditions). Digoxin blood levels
may be increased when taken together with Inspra.
* 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 Inspra 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 Inspra thereby
prolonging the effect of Inspra 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 Inspra
and thus decrease its effect.
Inspra with food and drink
Inspra 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 Inspra 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 Inspra. If this should happen, do not drive or
operate machinery.
Inspra contains lactose monohydrate
Inspra contains 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 Inspra

Always take this medicine exactly as your doctor or pharmacist has told you.
You should check with your doctor or pharmacist if you are not sure.
Inspra tablets may be taken together with food or on an empty stomach.
Swallow the tablets whole with plenty of water.
Inspra 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 Inspra 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.

Ref: LTT6869/171014/3/B

®

®

Inspra 25mg Film-Coated Tablets / Inspra 50mg Film-Coated Tablets
(Eplerenone)
Patient Information Leaflet (continued)
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, Inspra 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
Inspra”).
For the elderly: no adjustment of the starting dose is required.

*
*
*
*
*

feeling weak and generally unwell
increased 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, pharmacist or nurse. 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.

For children and adolescents: Inspra is not recommended.
If you take more Inspra than you should
If you take more Inspra 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 Inspra
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 Inspra
It is important to keep taking Inspra 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.
Other reported side effects include:
Common side-effects (occurs between 1 and 10 out of every 100 patients):
* 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
* abnormal functioning of your kidney
* rash
* itching
* muscle spasm and pain
* increased urea level in the blood
Uncommon side-effects (occurs between 1 and 10 out of every 1,000
patients):
* eosinophilia (increase in certain white blood cells)
* dehydration
* elevated quantity of cholesterol or triglycerides (fats) in your blood
* low sodium blood levels
* insomnia (difficulty sleeping)
* 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

5

How to store Inspra

Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Inspra film-coated tablets after the expiry date stated on the pack
and blister. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Contents of the pack and other information

What Inspra contains
Each Inspra 25mg Film-Coated Tablet contains 25mg of eplerenone as the
active ingredient.
Each Inspra 50mg Film-Coated Tablet contains 50mg of eplerenone as the
active ingredient.
Inspra 25 mg and 50 mg film-coated tablets also contain the following
inactive ingredients: lactose monohydrate, microcrystalline cellulose,
croscarmellose sodium, hypromellose, sodium lauryl sulphate, talc and
magnesium stearate.
The opadry yellow coating of Inspra 25 mg and 50 mg film-coated tablets
contains hypromellose, titanium dioxide (E171), macrogol 400, polysorbate
80, yellow iron oxide (E172), red iron oxide (E172).
What Inspra looks like and contents of the pack
The Inspra 25 mg tablets are diamond shaped yellow tablets with “Pfizer” on
one side and “NSR” over “25” on the other.
The Inspra 50 mg tablets are diamond shaped yellow tablets with “Pfizer” on
one side and “NSR” over “50” on the other.
Inspra 25 mg and 50 mg film-coated tablet are available in blister packs
containing 20 or 30 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by NPIL Pharmaceuticals (UK) Ltd, Morpeth
Plant, Whalton Road, Morpeth, Northumberland, NE61 3YA, United Kingdom
and is procured from within the EU. Product Licence Holder: LTT Pharma
Ltd, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE. Repackaged by Lexon (UK) Ltd, B98 0RE.

POM

PL 33723/0068 Inspra 25mg Film-Coated Tablets
PL 33723/0069 Inspra 50mg Film-Coated Tablets

Inspra is a registered trademark of Pfizer.
Revision date: 17/10/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: LTT6869/171014/4/F

Eplerenone 25mg Film-Coated Tablets / Eplerenone 50mg Film-Coated Tablets
Patient Information Leaflet
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.
Your medicine is called either Eplerenone 25mg Film-Coated Tablets or
Eplerenone 50mg Film-Coated Tablets, throughout this leaflet it will be
refered to as Eplerenone
What is in this leaflet:
1 What Eplerenone is and what it is used for
2 What you need to know before you take Eplerenone
3 How to take Eplerenone
4 Possible side effects
5 How to store Eplerenone
6 Contents of the pack and other information

1

What Eplerenone is and what it is used for

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

Do not take Eplerenone
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.

*

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Eplerenone.
* if you have kidney or liver disease (see also “Do not take Eplerenone”)
* 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
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
You must not take Inspra with the following medications (see section “Do not
take Eplerenone”):
* Itraconazole or ketoconazole (used to treat fungal infections), ritonavir,
nelfinavir (antiviral medication for treating HIV), clarithromycin, elithromycin
(used to treat bacterial infections) or nefazodone (used to treat
depression) as these drugs reduce the break-down 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.

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 Inspra.
* Digoxin (used in the treatment of heart conditions). Digoxin blood levels
may be increased when taken together with Inspra.
* 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 Inspra 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 Inspra thereby
prolonging the effect of Inspra 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 Inspra
and thus decrease its effect.
Eplerenone 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 Inspra 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 Inspra. If this should happen, do not drive or
operate machinery.
Eplerenone contains lactose monohydrate
Eplerenone contains 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 Eplerenone

Always take this medicine exactly as your doctor or pharmacist has told you.
You should 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 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 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.

Ref: LTT6869/171014/4/B

Eplerenone 25mg Film-Coated Tablets / Eplerenone 50mg Film-Coated Tablets
Patient Information Leaflet (continued)
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”).
For the elderly: no adjustment of the starting dose is required.

* increased urea and creatinine blood levels which may indicate kidney
problems

* kidney inflammation
* enlargement of breasts in men
* changes in blood test results
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

For children and adolescents: Eplerenone is not recommended.
If you take more Eplerenone 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
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 Eplerenone
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:
You should seek immediate medical attention
* swollen face, tongue or throat
* difficulty swallowing
* hives and difficulties breathing
These are the symptoms of angioneurotic oedema.
Other reported side effects include:
Common side-effects (occurs between 1 and 10 out of every 100 patients):
* 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
* abnormal functioning of your kidney
* rash
* itching
* muscle spasm and pain
* increased urea level in the blood
Uncommon side-effects (occurs between 1 and 10 out of every 1,000
patients):
* eosinophilia (increase in certain white blood cells)
* dehydration
* elevated quantity of cholesterol or triglycerides (fats) in your blood
* low sodium blood levels
* insomnia (difficulty sleeping)
* 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

5

How to store Eplerenone

Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Eplerenone film-coated tablets after the expiry date stated on the
pack and blister. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Contents of the pack and other information

Each Eplerenone 25mg Film-Coated Tablet contains 25mg of eplerenone as
the active ingredient.
Each Eplerenone 50mg Film-Coated Tablet contains 50mg of eplerenone as
the active ingredient.
Eplerenone 25 mg and 50 mg film-coated tablets also contain the following
inactive ingredients: lactose monohydrate, microcrystalline cellulose,
croscarmellose sodium, hypromellose, sodium lauryl sulphate, talc and
magnesium stearate.
The opadry yellow coating of Eplerenone 25 mg and 50 mg film-coated
tablets contains hypromellose, titanium dioxide (E171), macrogol 400,
polysorbate 80, yellow iron oxide (E172), red iron oxide (E172).
What Eplerenone looks like and contents of the pack
The Eplerenone 25 mg tablets are diamond shaped yellow tablets with
“Pfizer” on one side and “NSR” over “25” on the other.
The Eplerenone 50 mg tablets are diamond shaped yellow tablets with
“Pfizer” on one side and “NSR” over “50” on the other.
Eplerenone 25 mg and 50 mg film-coated tablet are available in blister packs
containing 20 or 30 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by NPIL Pharmaceuticals (UK) Ltd, Morpeth
Plant, Whalton Road, Morpeth, Northumberland, NE61 3YA, United Kingdom
and is procured from within the EU. Product Licence Holder: LTT Pharma
Ltd, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE. Repackaged by Lexon (UK) Ltd, B98 0RE.

POM

PL 33723/0068 Eplerenone 25mg Film-Coated Tablets
PL 33723/0069 Eplerenone 50mg Film-Coated Tablets

Revision date: 17/10/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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