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EPLERENONE 25MG FILM-COATED TABLETS

Active substance(s): EPLERENONE

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CUSTOMER: Waymade
PRODUCT: Inspra 25mg 50mg tabs
CODE:

06464/2934 2935E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

06/12/13

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 06/12/13

«PAdBì
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED AUGUST 2013
REPORTING OF SIDE EFFECTS
Pg 1

Pg 4

6. Contents of the pack and other information
What Inspra contains
The active substance of Inspra film-coated tablets is eplerenone. Each tablet contains 25 mg or 50 mg of
eplerenone.
Inspra 25 mg and 50 mg film-coated tablets also contain the following inactive ingredients: lactose
monohydrate, microcrystalline cellulose (E460), croscarmellose sodium (E468), hypromellose (E464), sodium
laurilsulfate, talc (E553b) and magnesium stearate (E470b).
The opadry yellow coating of Inspra 25 mg and 50 mg film-coated tablets contains hypromellose (E464),
titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), iron oxide yellow (E172), iron oxide red
(E172).
What Inspra looks like and contents of the pack
The Inspra 25 mg tablet is a yellow, film-coated, diamond –shaped tablet, marked with “Pfizer” debossed on
one side of the tablet and “NSR” over “25” on the other side of the tablet.
The Inspra 50 mg tablet is a yellow, film-coated, diamond-shaped tablet, marked with “Pfizer” debossed on
one side of the tablet and “NSR” over “50” on the other side of the tablet.
Inspra 25 mg and 50 mg film-coated tablets are available as blister packs of 30 tablets.
POM

PL No: 06464/2934 25mg Tablets
PL No: 06464/2935 50mg Tablets

These products are manufactured by Pfizer PGM, Zone Industrielle – 29 route des Industries 37530
Pocé-sir-Cisse, France, or, Piramal Healthcare UK Limited., Whalton Road, Morpeth, Northumberland, NE 16
3YA, United Kingdom procured within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref). 06.12.2013
Inspra is a registered trademark of C.P. Pharmaceuticals International C.V.

INSPRA® 25 mg FILM-COATED TABLETS/
EPLERENONE 25 mg FILM-COATED TABLETS
INSPRA® 50 mg FILM-COATED TABLETS/
EPLERENONE 50 mg FILM-COATED TABLETS
(eplerenone)
Patient Information Leaflet
Your medicine is known by all of the above names but will be referred to as Inspra throughout this 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.
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 ciclosporin (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.

Pg 2 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

-7Æ7»³
û¬ET).

XÆE)f

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade
PRODUCT: Inspra 25mg 50mg tabs
CODE:

06464/2934 2935E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

06/12/13

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 06/12/13

«PAdBì
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED AUGUST 2013
REPORTING OF SIDE EFFECTS

Pg 2

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.

Ciclosporin or tacrolimus (used to treat skin conditions such as psoriasis or eczema, and to prevent
rejection after organ transplantation). These drugs can cause kidney problems and therefore
increase the risk of high potassium levels in your blood.

Non-steroidal anti-inflammatory drugs (NSAIDs - certain pain killers such as ibuprofen, used to
relieve pain, stiffness and inflammation). These drugs may lead to kidney problems and therefore
increase the risk of high potassium levels in your blood.

Trimethoprim (used to treat bacterial infections) may increase the risk of high potassium levels in
your blood.

Alpha I blockers, such as prazosin or alfuzosin (used to treat high blood pressure and particular
prostate conditions) may lead to a fall in blood pressure and dizziness upon standing.

Tricyclic antidepressants such as amitryptyline or amoxapine (for treatment of depressions),
antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (for the treatment
of psychiatric disorders), amifostine (used during cancer chemotherapy) and baclofen (used to treat
muscle spasm). These drugs may lead to a fall in blood pressure and dizziness upon standing.

Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin
conditions) and tetracosactide (mainly used for diagnosing and treating disorders of the adrenal
cortex) may reduce the blood-pressure lowering effect of 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.
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).

Pg 3

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
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet.
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 {EXP} 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.
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.

Pg 4 !

Pg 3 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

-7Æ7»³
û¬ET).

XÆE)f

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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Source: Medicines and Healthcare Products Regulatory Agency

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

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