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INSPRA 50 MG FILM-COATED TABLETS

Active substance(s): EPLERENONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

INSPRA® 50 MG FILM-COATED TABLETS
(eplerenone)
Your medicine is known by the above name but will be referred to as
Inspra® throughout this leaflet.
This product is also available in other strength (25 mg).
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.
2.
3.
4.
5.
6.

What Inspra® is and what it is used for
What you need to know before you take Inspra®
How to take Inspra®
Possible side effects
How to store Inspra®
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, telithromycin (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. 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.
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®

 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
musculoskeletal 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, 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.

If it is almost time for your next tablet, skip the tablet you missed and take
your next tablet when it is due.

5. HOW TO STORE INSPRA®

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.

This medicinal product does not require any special storage conditions.

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.

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date {EXP} stated on the pack
and blister. The expiry date refers to the last day of that month.
If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.

If you have any further questions on the use of this medicine ask your
doctor or pharmacist.

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.

4. POSSIBLE SIDE EFFECTS

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

What Inspra® contains

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 in 100 people) side effect.

The active substance of Inspra® film-coated tablets is eplerenone. Each
film-coated tablet contains 50 mg of eplerenone.
Inspra® 50 mg film-coated tablets also contain the following inactive
ingredients: lactose monohydrate, microcrystalline cellulose,
croscarmellose sodium, hypromellose, sodium laurilsulfate, talc and
magnesium stearate.
The opadry yellow coating of Inspra® 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

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
 elevated quantity of cholesterol in your blood
 insomnia (difficulty 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
 increased urea level in the blood

The Inspra® 50 mg tablet is a yellow diamond-shaped film-coated tablet
marked with "NSR" over "50" on one side and plain on the other side.
Inspra® is available in blister packs containing 30 tablets.
Who manufactured your medicine
Your medicine is manufactured by Pfizer PGM, Zone Industrielle-29
Route des Industries, 37530 Pocé-sur-Cisse, France. Procured from
within the EU and repackaged by the Product Licence holder:
Beachcourse limited, 20 Alliance Court, Alliance road, London W3 0RB

PL 16378/0550

Inspra® 50 mg film-coated tablets

POM

Revision date: 16.05.2016
Leaflet reference: INSP50
Inspra® is a registered trademark of the Pfizer group of companies.

PACKAGE LEAFLET: INFORMATION FOR THE USER

EPLERENONE 50 MG FILM-COATED TABLETS
Your medicine is known by the above name but will be referred to as
Eplerenone throughout this leaflet.
This product is also available in other strength (25 mg).
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.
2.
3.
4.
5.
6.

What Eplerenone is and what it is used for
What you need to know before you take Eplerenone
How to take Eplerenone
Possible side effects
How to store Eplerenone
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 Eplerenone 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, telithromycin (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 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.
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 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 breast-feeding
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.
Eplerenonecontains 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. 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.
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.
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

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
musculoskeletal 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, 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 EPLERENONE

If it is almost time for your next tablet, skip the tablet you missed and take
your next tablet when it is due.

Keep out of the sight and reach of children.

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 use this medicine after the expiry date {EXP} stated on the pack
and blister. The expiry date refers to the last day of that month.

Do not take a double dose to make up for the forgotten tablet.
If you stop taking Eplerenone

This medicinal product does not require any special storage conditions.

If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.

It is important to keep taking Eplerenone as prescribed unless your doctor
tells you to stop your treatment.

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.

If you have any further questions on the use of this medicine ask your
doctor or pharmacist.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

What Eplerenone contains

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 (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
 elevated quantity of cholesterol in your blood
 insomnia (difficulty 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
 increased urea level in the blood
 increased creatinine blood levels which may indicate kidney problems

The active substance of Eplerenone film-coated tablets is eplerenone.
Each film-coated tablet contains 50 mg of eplerenone.
Eplerenone 50 mg film-coated tablets also contain the following inactive
ingredients: lactose monohydrate, microcrystalline cellulose,
croscarmellose sodium, hypromellose, sodium laurilsulfate, talc and
magnesium stearate.
The opadry yellow coating of Eplerenone 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 50 mg tablet is a yellow diamond-shaped film-coated
tablet marked with "NSR" over "50" on one side and plain on the other
side.
Eplerenone is available in blister packs containing 30 tablets.
Who manufactured your medicine
Your medicine is manufactured by Pfizer PGM, Zone Industrielle-29
Route des Industries, 37530 Pocé-sur-Cisse, France. Procured from
within the EU and repackaged by the Product Licence holder:
Beachcourse limited, 20 Alliance Court, Alliance road, London W3 0RB

PL 16378/0550

Eplerenone 50 mg film-coated tablets

Revision date: 16.05.2016
Leaflet reference: EPLE50

POM

Expand view ⇕

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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