Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking INSPRA?
INSPRA contains the active ingredient eplerenone. INSPRA is used to treat heart failure
in patients who have experienced a heart attack and to reduce the risk of death or
need for hospitalisations due to heart failure in patients with chronic heart failure.
2. What should I know before I take INSPRA?
Do not take if you have ever had an allergic reaction to INSPRA or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I take INSPRA? in the full CMI.
3. What if I am taking other medicines?
4. How do I take INSPRA?
Your doctor will tell you how many tablets you need to take each day. The usual starting
dose of INSPRA is 25 mg taken once a day. More instructions can be found in Section
4. How do I take INSPRA? in the full CMI.
5. What should I know while taking INSPRA?
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Things you should do
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Call your doctor straight away if you feel light-headed or dizzy after taking your
first dose of INSPRA, or when your dose is increased.
Make sure you drink enough water during exercise and hot weather when you are taking
INSPRA, especially if you sweat a lot.
Remind any doctor, dentist or pharmacist you visit that you are taking INSPRA.
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Things you should not do
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Do not stop taking your medicine, or lower the dosage, without checking with your
doctor.
Do not take INSPRA to treat any other complaints unless your doctor tells you to.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how INSPRA
affects you.
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Looking after your medicine
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Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store it in the bathroom or near a sink, or in the car or on window sills.
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6. Are there any side effects?
Speak to your doctor if you have any of these less serious side effects and they worry
you: feeling light-headed, dizzy or faint, stomach or bowel problems (e.g. feeling sick
(nausea) or vomiting, diarrhoea, constipation, flatulence or wind), cough, sore throat,
headache, rash, itchy skin, high temperature, signs of an infection, back pain.
Tell your doctor as soon as possible if you notice any of these serious side effects: heart flutters, increased heart rate, unusual tiredness, weakness, muscle spasms
and pain, abdominal pain, enlargement of the breasts in men, reduced sense of touch,
increased sweating, feeling weak and generally unwell, problems with sleeping.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if you notice any of these very serious side effects: shortness of breath, swelling of the feet or legs due to fluid build up, chest pain
which may spread to the neck and shoulders, swelling of the face, lips, mouth, tongue
or throat which may cause difficulty in swallowing or breathing.
Active ingredient(s):
eplerenone
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking INSPRA. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking INSPRA.
Where to find information in this leaflet:
1. Why am I taking INSPRA?
INSPRA contains the active ingredient eplerenone.
INSPRA belongs to a group of medicines called 'selective aldosterone blockers' that
stop the action of aldosterone.
INSPRA is used to:
treat heart failure in patients who have experienced a heart attack
reduce the risk of death or need for hospitalisations due to heart failure in patients
with chronic heart failure.
A heart attack occurs when one of the major blood vessels supplying blood to your
heart becomes blocked. This means that your heart cannot receive the oxygen it needs
and becomes damaged. This may lead to further problems, such as heart failure, irregular
heart rhythms and blood clots.
Heart failure means that the heart muscle is weak and cannot pump blood strongly enough
to supply all the blood needed throughout the body. Heart failure is not the same
as heart attack, and may start off with mild or no symptoms, but as the condition
progresses, patients may feel short of breath or may get tired easily after light
physical activity such as walking. Some patients may wake up short of breath at night,
or have to prop their heads up during sleep to avoid this problem. Fluid may collect
in different parts of the body, often first noticed as swollen ankles and feet.
How INSPRA works
Your body makes a substance called aldosterone. It is important for regulating blood
pressure and is one of the factors involved in heart function. Sometimes aldosterone
can cause changes in our body that lead to heart failure. INSPRA works by blocking
the action of aldosterone, and slowing the progression of heart failure by reducing
heart damage.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
There is no evidence that this medicine is addictive.
This medicine is available only with a doctor's prescription.
Use in children
The safety and effectiveness of INSPRA in children have not been established.
2. What should I know before I take INSPRA?
Warnings
Do not take INSPRA if:
you are allergic to eplerenone, or any of the ingredients listed at the end of this
leaflet.
Some of the symptoms of an allergic reaction may include:
skin rash
itchiness
shortness of breath
swelling of the face, lips or tongue
muscle pain or tenderness
joint pain
Always check the ingredients to make sure you can take this medicine.
you have or have had any of the following medical conditions:
very high levels of potassium in your blood
severely reduced kidney function. Your doctor will determine your kidney function
severe liver problems.
you are currently taking any of the following medicines:
potassium-sparing diuretics (e.g. spironolactone, amiloride), used to help the kidneys
get rid of salt and water by increasing the amount of urine produced
ketoconazole and itraconazole used to treat fungal infections
clarithromycin, used to treat bacterial infections
saquinavir, ritonavir, for the treatment of HIV infections.
Taking INSPRA together with the above medicines can lead to serious side effects.
you are pregnant
you are breast-feeding.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes
take any medicines for any other conditions
have or have had any of the following medical conditions:
high levels of potassium in your blood
diabetes
long term kidney disease
liver problems.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take INSPRA if you are pregnant.
Check with your doctor if you are pregnant or intend to become pregnant.
It may affect your developing baby if you take it during pregnancy.
Do not breast-feed if you are taking INSPRA.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
The active ingredient in INSPRA may pass into breast milk and there is a possibility
that your baby may be affected.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you start
taking INSPRA.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Tell your doctor or pharmacist if you are taking any of the following:
medicines known as angiotensin converting enzyme (ACE) inhibitor and/or angiotensin
receptor blocker (ARB), such as quinapril, losartan. These are used to treat high
blood pressure and some other heart conditions and may increase the risk of high potassium
levels in your blood
non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to relieve pain, swelling
and other symptoms of inflammation including aspirin and ibuprofen
lithium, a medicine used to treat mood swings
neuroleptics, used to treat certain mental illnesses
tricyclic antidepressants, used to treat certain mental illnesses
St John's Wort, used in the management of depression
carbamazepine, used to control seizures, facial pain or certain types of mood disorders
phenytoin and phenobarbitone, medicines used to control seizures
potassium-sparing diuretics, such as spironolactone, amiloride
potassium supplements, or salt substitutes which contain potassium
medicines used to treat fungal infections such as ketoconazole, itraconazole
certain antibiotics used to treat bacterial infections, such as erythromycin, trimethoprim,
rifampicin
saquinavir, ritonavir, for the treatment of HIV infections
immunosupressive agents such as cyclosporin, tacrolimus
baclofen, a muscle relaxant
prazosin, used to treat high blood pressure and other medical conditions
alfuzosin, for the treatment of benign prostatic hyperplasia
amifostine, used in combination with cancer treatments
any other medicines used to treat high blood pressure or heart failure.
Tell your doctor if you are taking salt tablets.
Taking INSPRA together with salt tablets can lead to serious side effects.
Some medicines may interfere with INSPRA and affect how it works.
You may need different amounts of your medicines, or you may need to take different
medicines. Your doctor will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect INSPRA.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
4. How do I take INSPRA?
How much to take
Your doctor will tell you how many tablets you need to take each day. This may depend
upon your age, your kidney condition, the potassium level in your blood, and whether
or not you are taking any other medicines.
The usual starting dose of INSPRA is 25 mg taken once a day. After about 4 weeks,
your doctor may increase the dose to 50 mg once a day.
Your doctor will do blood tests to help determine the correct dose of INSPRA for you.
Follow the instructions provided by your doctor or pharmacist carefully and take INSPRA
until your doctor tells you to stop.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
When to take INSPRA
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take the tablets.
Your tablets may be taken with or after a meal, or on an empty stomach.
How to take INSPRA
Swallow the tablets whole with a full glass of water.
How long to take INSPRA
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important
to keep taking your medicine even if you feel well.
If you forget to take INSPRA
INSPRA should be taken regularly at the same time each day.
If you miss your dose at the usual time, and it is less than 12 hours before your
next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much INSPRA
If you think that you or anyone else have taken too much INSPRA, urgent medical attention
may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much INSPRA, you may feel light-headed.
5. What should I know while taking INSPRA?
Things you should do
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may occasionally do a blood test to check your potassium levels and see
how your kidneys are working. Your dose of INSPRA may be adjusted by your doctor,
depending on the potassium levels in your blood.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking INSPRA.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor that you are taking
this medicine.
Make sure you drink enough water during exercise and hot weather when you are taking
this medicine, especially if you sweat a lot.
If you do not drink enough water while taking INSPRA, you may feel faint, light-headed
or sick. This is because your blood pressure is dropping suddenly. If you continue
to feel unwell, tell your doctor.
If you have excess vomiting or diarrhoea while taking INSPRA, tell your doctor.
You may lose too much water and salt and your blood pressure may drop too much.
Call your doctor straight away if you:
feel light-headed or dizzy after taking your first dose of INSPRA, or when your dose
is increased.
Remind any doctor, dentist or pharmacist you visit that you are taking INSPRA.
Things you should not do
Do not take INSPRA to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine, or lower the dosage, without checking with your
doctor.
If you stop taking it suddenly, your condition may worsen or you may have unwanted
side effects.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how INSPRA
affects you.
INSPRA may cause dizziness and feeling faint in some people. If you have this symptom,
do not drive, operate machinery or do anything else that could be dangerous.
Looking after your medicine
Keep your INSPRA tablets in the pack until it is time to take them.
If you take the tablets out of the pack they will not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking INSPRA or your condition changes. Tell your doctor even if you think the
problem is not connected with the medicine or is not listed in this leaflet.
INSPRA helps most people with heart failure, but it may have unwanted side effects
in some people.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
It is often difficult to tell whether side effects are the result of taking INSPRA,
or the effects of your heart failure or side effects of other medicines you may be
taking. For this reason it is important to report any change in your condition. Your
doctor may want to change your dose or advise you to stop taking INSPRA.
If you are over 65 years of age you may have an increased chance of having some side
effects, as you may be more sensitive to the effects of the medication.
Do not be alarmed by the following list of side effects.
You may not experience any of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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feeling light-headed, dizzy or faint
stomach or bowel problems
feeling sick (nausea) or vomiting
diarrhoea
constipation
flatulence or wind
cough
sore throat
headache
rash, itchy skin
high temperature, signs of an infection
back pain
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Speak to your doctor if you have any of these less serious side effects and they worry
you
.
This list includes the more common or noticeable side effects of your medicine.
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Serious side effects
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Serious side effects
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What to do
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heart flutters, increased heart rate
unusual tiredness, weakness
muscle spasms and pain
abdominal pain
enlargement of the breasts in men
reduced sense of touch
increased sweating
feeling weak and generally unwell
problems with sleeping
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Tell your doctor as soon as possible if you notice any of these serious side effects.
This list includes side effects that may require medical attention. Serious side effects
are rare.
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Very serious side effects
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Very serious side effects
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What to do
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shortness of breath, swelling of the feet or legs due to fluid build up
chest pain which may spread to the neck and shoulders
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing
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Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if you notice any of these very serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some of these side effects (for example, changes in potassium levels, thyroid function,
or cholesterol level) can only be found when your doctor does tests from time to time
to check your progress.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems .By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What INSPRA contains
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Active ingredient
(main ingredient)
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eplerenone 25 mg or 50 mg per tablet
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Other ingredients
(inactive ingredients)
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lactose monohydrate
microcrystalline cellulose
croscarmellose sodium
hypromellose
sodium lauryl sulfate
purified talc
magnesium stearate
titanium dioxide
macrogol 400
polysorbate 80
iron oxide yellow (CI77492)
iron oxide red (CI77491).
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Potential allergens
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lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What INSPRA looks like
INSPRA 25 mg: Arc-diamond shape, yellow, film-coated tablet with the following debossing:
'Pfizer' on one side of the tablet, 'NSR' over '25' on the other. (AUST R 100162)
INSPRA 50 mg: Arc-diamond shape, yellow, film-coated tablet with the following debossing:
'Pfizer' on one side of the tablet, 'NSR' over '50' on the other. (AUST R 100163)
INSPRA is available in blister packs of 30 tablets.
Who distributes INSPRA
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in December 2023.
INSPRA® is a Viatris company trade mark
INSPRA_cmi\Dec23/00