Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using EPIPEN?
EPIPEN contains the active ingredient adrenaline (epinephrine). EPIPEN is only to
be used for the immediate EMERGENCY TREATMENT of a SEVERE ALLERGIC REACTION (also
known as ANAPHYLAXIS). For more information, see Section
1. Why am I using EPIPEN? in the full CMI.
2. What should I know before I use EPIPEN?
EPIPEN is a life-saving treatment in the emergency management of severe allergic reactions.
Therefore, it should not be withheld from anyone who is considered to need it. It is important to know how to use an EPIPEN BEFORE a severe allergic reaction causes
a medical emergency.
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
.
3. What if I am taking other medicines?
Some medicines may interfere with EPIPEN and affect how it works.
4. How do I use EPIPEN?
EPIPEN delivers one measured dose of adrenaline intended for a person who weighs 30
kg or more. It may be prescribed for a child who weighs between 15 kg and 30 kg.
5. What should I know while using EPIPEN?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using EPIPEN.
Check the expiry date on EPIPEN and request for replacement prior to the expiry date.
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Things you should not do
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Do not use EPIPEN to treat any other medical conditions including other types of shock
unless advised by the doctor.
Do not use EPIPEN if the solution is cloudy, coloured, contains sediment or the viewing
window is obscured.
Do not take off the blue safety release until required.
Do not touch the orange end on any person or object while you are taking off the blue
safety release and/or after you have taken off the blue safety release.
Do not inject into hands, feet, ears, nose, buttocks, genital area or into blood vessels.
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Driving or using machines
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Your ability to drive and use machines may be affected by the anaphylactic reaction
and possible adverse effects to adrenaline.
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Drinking alcohol
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Alcohol may increase the effects of this medicine.
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Looking after your medicine
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Keep the Auto-Injector in the protective carry tube until required. Protect from light.
Store below 25°C. Temperature excursions between 15°C to 25°C permitted. Do not refrigerate.
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6. Are there any side effects?
Tell your doctor or pharmacist if you experience a fast or noticeable heartbeat, difficulty
breathing, chest pain or shortness of breath. This is not a complete list of all possible side effects.
Active ingredient(s):
adrenaline (epinephrine)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using EPIPEN. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using EPIPEN.
Where to find information in this leaflet:
1. Why am I using EPIPEN?
EPIPEN contains the active ingredient adrenaline (epinephrine). Adrenaline belongs to a group of medicines called adrenergic and dopaminergic agents
which are classified as cardiac stimulants. In some countries, adrenaline is known
as epinephrine.
Adrenaline is a natural hormone released in response to stress. Adrenaline is known
to:
shrinks abnormally wide blood vessels and
makes the heart beat strongly
This helps improve the very low blood pressure and poor circulation that occur in
a severe allergic reaction.
Adrenaline also:
relaxes the lungs. This eases breathing and lessens wheezing.
helps stop:
swelling, for example, of the face, lips, throat, tongue, hands and feet;
skin rash and/or
itching
EPIPEN is only to be used for the immediate EMERGENCY TREATMENT of a SEVERE ALLERGIC
REACTION (also known as ANAPHYLAXIS). Your doctor or pharmacist will explain what
this is like, so that you know when you must use EPIPEN.
EPIPEN is used to treat people who have a severe allergic reaction caused by, for
example, hypersensitivity to
food
medicines
stinging insects
insect bites
latex or
other allergens, possibly unidentified.
Avoidance of known allergens is most important in preventing severe allergic reactions.
A severe allergic reaction, otherwise known as anaphylaxis, is overwhelming and life-threatening.
It affects the whole body or usually several parts of the body.
In particular:
heart and blood circulation
This may cause, for example, low blood pressure and collapse, or abnormal heartbeat
or function.
air passages and lungs
This causes difficulty in breathing, with noisy wheezing or gasping, possibly with
sneezing and a very runny nose.
stomach and bowels
This may cause nausea, vomiting, diarrhoea and abdominal cramps, often severe.
skin (very common)
This causes flushing, itching, skin rash, hives or swelling, which may be widespread
or in one part of the body.
brain
There may be fits or confusion due to lack of oxygen.
It is important to act quickly to treat a severe allergic reaction.
EPIPEN:
provides convenient first-aid
may be self-administered or administered by a carer
has a spring-activated, hidden needle
automatically injects one pre-measured dose of adrenaline
is for single use only.
If you have any questions about this, talk to your doctor or pharmacist.
2. What should I know before I use EPIPEN?
The EPIPEN Auto-Injector is simple to use. Please read and follow the step-by-step
instructions.
Do not remove the blue safety release until you need to use EPIPEN and are ready to
use it. The safety release stops EPIPEN from “firing” or working.
Warnings
EPIPEN is a life-saving treatment in the emergency management of severe allergic reactions.
Therefore, it should not be withheld from anyone who is considered to need it.
There is no visible needle. This helps overcome fear of injection. The hidden needle
is very fine so that the injection does not usually hurt.
The Auto-Injector has a clear viewing window so you can see the contents.
Do not use EPIPEN if:
the packaging is torn, doesn’t look quite right or shows signs of tampering
the contents:
are cloudy or
are coloured or
contain sediment or
if the viewing window is obscured
These changes indicate that the effectiveness of the drug product may be decreased.
When the viewing window is obscured, the Auto-Injector cannot be used again.
Help in using EPIPEN
It is important to know how to use an EPIPEN BEFORE a severe allergic reaction causes
a medical emergency.
Ask your doctor or pharmacist how you can get an EPIPEN Training Device for practice.
An EPIPEN Training Device is similar to the real EPIPEN. However, the EPIPEN Training
Device:
has NO medicine (adrenaline) and
has NO needle and
“fires” quietly and less forcefully
can be reset and reused.
Ask your doctor or pharmacist to show you how to practice with the EPIPEN Training
Device. If you practice using the EPIPEN Training Device, it will help you to learn
how to use the real EPIPEN.
It is important to regularly ask your doctor or pharmacist to demonstrate use with
an EPIPEN Training Device.
EPIPEN is effective as emergency treatment of a severe allergic reaction ONLY when
used according to the directions in this leaflet.
Give WITH CAUTION to those who have
high blood pressure
thyroid problems
high pressure in the eye (narrow-angle glaucoma).
If you have a thick-subcutaneous fat layer, there is a risk of the adrenaline not
reaching the muscle tissue resulting in a suboptimal effect. In such individuals there
may be a higher likelihood of needing a second injection with an additional EPIPEN.
Take care also when giving EPIPEN to those:
having an anaesthetic
or who have:
diabetes
heart disease
allergy to EPIPEN
brain damage.
Check with your doctor or pharmacist if you have:
heart disease or high blood pressure
Parkinson's disease
depression, or are on medication for depression
thyroid problems, or are on thyroid medication
diabetes
high pressure in the eye (narrow angle glaucoma)
asthma
ever had an allergic reaction to sodium metabisulfite
severe kidney problems
a tumor in your prostate (prostatic adenoma leading to residual urine)
high calcium levels or low potassium levels in your blood.
Talk to your doctor if you are allergic to sodium metabisulfite or any of the ingredients
listed at the end of this leaflet and have not consulted your doctor or specialist
beforehand.
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
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
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.
Some medicines may interfere with EPIPEN
and affect how it works. These include medicines for:
heart disease (e.g. digitalis (digoxin), quinidine, alpha and beta blocking medicines)
treatment of Parkinson’s disease (e.g. catechol-O-methyl transferase inhibitors or
levodopa)
depression (especially “tricyclic antidepressants” or monoamine oxidase inhibitors)
thyroid hormone (e.g. levothyroxine sodium or thyroid hormones)
diabetes
making you breathe more easily, used for asthma (e.g. theophylline)
use in labour (e.g. oxytocin)
acting on the nervous system (parasympatholytics)
treating allergies (antihistamines e.g. diphenhydramine or chlorpheniramine)
anaesthesia (e.g. halothane, cyclopropane or trichlorethylene).
These medicines may affect how well the adrenaline in EPIPEN works.
People with diabetes should carefully monitor their glucose levels after use of EPIPEN
or EPIPEN JR Auto-Injector as adrenaline can affect the amount of insulin made by
the body, thus increasing the blood glucose level.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect EPIPEN.
4. How do I use EPIPEN?
Follow carefully all directions given to you by your doctor or pharmacist.
They may differ from the information contained in this leaflet.
If you do not understand the instructions in this leaflet or on the EPIPEN Auto-Injector,
ask your doctor or pharmacist for help.
How much to use
For single use only. EPIPEN Auto-Injector delivers a fixed dose of adrenaline. The
EPIPEN Auto-Injector must be replaced immediately after use.
The dose will be decided by your doctor, who will adjust it individually for you.
Use in Adults weighing 30 kg or more
EPIPEN is intended for a person who weighs 30 kg or more and has been assessed by
their doctor or pharmacist.
Note:
Selection of the appropriate dosage is determined according to the careful medical
assessment, patient's body weight
and the severity of their symptoms. The doctor or pharmacist may choose to recommend
more or less than this amount.
There may be instances where the doctor or pharmacist will recommend the use of EPIPEN
JR in some adults, based on careful medical assessment.
Unless otherwise advised by the doctor or pharmacist, EPIPEN JR Auto-Injector should
be used for children who weigh between 15 kg and 30 kg.
If you have any questions about this, talk to your doctor or pharmacist.
When to use EPIPEN
Use EPIPEN immediately if you have signs and symptoms of a severe allergic reaction,
as described by your doctor or pharmacist. Symptoms do vary. However, the symptoms
are likely to include:
collapse
difficulty in breathing
wheezing
swelling, especially of the face, lips, tongue or throat
flushing of the face
irregular or faint pulse
vomiting, diarrhoea, stomach cramps
skin rash, hives
itching
in some cases, loss of consciousness.
In case the first administration is not sufficient, you should carry two EPIPEN Auto-Injector
pens with you at all times.
How to use EPIPEN
Important Information - Before Use:
Before you ever need to use it, fully familiarise yourself with the EPIPEN Auto-Injector,
when and how it should be used.
It is recommended that your family members, carers, teachers are also instructed in
the correct use of the Auto-Injector.
Grip only the mid-section of the EPIPEN Auto-Injector. Avoid touching either end,
except when you remove the blue safety release. The blue safety release stops the
EPIPEN from “firing” or working.
Always point the orange end (which holds the needle) away from any part of any body,
except the planned injection site. This is the thigh of the person who has the severe
allergic reaction.
Always hold the leg firmly during injection especially in people who are uncooperative
and kick or move during an injection. This will reduce the risk of injection related
injuries.
Always keep the Auto-Injector away from the face and eyes.
Never inject the Auto-Injector into the buttock.
Carefully follow the step-by-step directions to make the EPIPEN work properly.
Step 1
Flip open the yellow cap on the protective carry tube.
Carefully tip and slide the EPIPEN Auto-Injector out of the carry tube.
Check the contents of the EPIPEN Auto-Injector through the viewing window. Make sure
the solution is clear, colourless and sediment-free.
Check the expiration date located on the side of the Auto-Injector. Replace the Auto-Injector
if the expiration date has passed.
Do not take off the blue safety release if you are not preparing for an injection.
Remember that the Auto-Injector is activated (“triggered”, ready to “fire”) as soon
as you take off the blue safety release.
Note:
To avoid an accidental injection, never place thumb, fingers or hand over the orange
end as this contains the needle. If an accidental injection happens, get medical help
right away.
Step 2
Make a fist around the EPIPEN Auto-Injector, with your thumb nearest to the blue safety
release (see FIGURE 1).
FIGURE 1
Step 3
Activate the EPIPEN Auto-Injector by removing the blue safety release with your other
hand (also shown in FIGURE 1). This “triggers” the EPIPEN. It is now ready to
“fire” the needle and
inject the medicine through the needle into the thigh muscle.
After you remove the blue safety release:
Do not touch or place thumb, fingers or hand over the orange end as this contains
the needle.
Do not “click” on either end of the EPIPEN Auto-Injector. The Auto-Injector does not
work like a retractable ball-point pen.
Do not bump the EPIPEN Auto-Injector if you are not preparing for an injection.
This will help prevent accidental activation of the EPIPEN Auto-Injector prior to
use.
Step 4
Hold the EPIPEN Auto-Injector at a 90° angle (right angle) to the outer part of the
thigh. Hold the orange end about 5 cm away from the thigh (see FIGURE 2).
FIGURE 2
Step 5
If you are administering the EPIPEN to another person, hold their leg firmly, especially
if they are uncooperative.
Push the orange end FIRMLY into the outer mid-thigh until a “click” is heard or felt.
Keep pressing the EPIPEN Auto-Injector firmly against the thigh for approximately
3 seconds (see FIGURE 3).
FIGURE 3
NOTE: EPIPEN may be used either
through clothing, as shown in FIGURE 3, or
directly on to skin.
When you press the orange end of the Auto-Injector firmly against the thigh, the hidden
needle “fires”. It injects the measured dose of adrenaline into the thigh muscle.
Step 6
Carefully take the EPIPEN Auto-Injector away from the thigh. The orange needle cover
will extend to cover the needle (see FIGURE 4).
FIGURE 4
Check the viewing window - it should now be obscured. If the viewing window is not
obscured, repeat steps 2 to 6 above.
Step 7
Seek further medical attention for yourself immediately. Although you have received
adrenaline from EPIPEN, you may need more medical treatment.
Either
Contact your doctor or
Call an ambulance (telephone 000 in Australia). State that you or your child have
had EPIPEN (intramuscular adrenaline) even if symptoms appear to be improving.
While waiting for the ambulance you should lie down with your feet raised unless this
makes you breathless in which case you should sit up. Ask someone to stay with you
until the ambulance arrives in case you feel unwell again.
Unconscious patients should be placed on their side in the recovery position.
Step 8
Record the time EPIPEN was given.
Step 9
With severe, persistent allergic reactions, repeat injections with an additional EPIPEN
may be necessary. The EPIPEN dose may be repeated every 5 to 15 minutes if symptoms
recur or have not subsided. Two Auto-Injectors should always be carried in case a second dose is required.
Do not inject more than two sequential doses of EPIPEN unless under medical supervision. An overdose of adrenaline could cause harm.
You or your child will need to go to hospital for observation and further treatment
as required. This is because the reaction may happen again at some time later.
Important Information - After Use
EPIPEN Auto-Injector is a single-use injectable device that delivers a fixed dose
of adrenaline.
The Auto-Injector cannot be reused. Do not try to reuse EPIPEN after the Auto-Injector has been activated.
The correct dose has been administered if the orange needle tip is extended and the
viewing window is blocked.
Do not tamper with the orange needle cover.
Do not replace the blue safety release.
After the Auto-Injector has been used, the extended needle cover will not fit back
into the carry tube.
Additional information about treatment of insect sting allergy
Use EPIPEN immediately if you have been stung or bitten by the insect and experience
the signs and symptoms as described by your doctor or pharmacist.
If the insect’s sting is easily accessible, remove the sting with your fingernails.
Do not squeeze, pinch or push the sting deeper into the skin. If available, ice packs
or sodium bicarbonate soaks may then be applied to the stung area.
Keep warm, calm, and as still as possible.
If you use too much EPIPEN
Because each EPIPEN contains only one dose, overdosage is unlikely. Overdosage may
lead to a rise in blood pressure. This may cause bleeding in the brain or fluid in
the lung.
If you think that you have used too much EPIPEN, you may need urgent medical attention.
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.
5. What should I know while using EPIPEN?
Things you should do
Check the expiry date on your EPIPEN and mark this expiry date on your calendar or
diary.
Also note on your calendar or diary to check the contents of your EPIPEN each month.
Do this through the viewing window.
Obtain a new EPIPEN immediately when:
the solution is brown or contains any particles or cloudiness
the viewing window is obscured. Return it to your doctor or pharmacist for disposal.
the Auto-Injector has previously been used
the Auto-Injector is about to expire.
The EPIPEN Auto-Injector can be damaged and made unusable if it is mishandled!
EPIPEN is NOT a toy. Keep it out of reach of children.
Things you should not do
Do not use EPIPEN to treat any other medical conditions including other types of shock
unless your doctor tells you to.
Do not use EPIPEN in a child who weighs below 15 kg
Talk to your doctor or pharmacist if this is the case so that a careful assessment
can be made and the appropriate dose selected based on the child’s weight and the
life-threatening nature of the reaction(s) for which EPIPEN is being prescribed.
Do not use EPIPEN if the solution is brown or contains any particles or cloudiness.
Do not touch the orange end on any person or object while you are taking off the blue
safety release and/or after you have taken off the blue safety release.
Do not inject into hands, feet, ears, nose, buttocks, genital area or into a blood
vessel.
Driving or using machines
Your ability to drive and use machines may be affected by the anaphylactic reaction
and possible adverse effects to adrenaline.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may increase the effect of adrenaline.
Looking after your medicine
Always handle the EPIPEN Auto-Injector carefully, so as not to accidentally activate
it or make it “fire” or work.
Keep EPIPEN readily available with the person for whom it is intended.
Keep EPIPEN in the protective carry tube until required. Protect from light.
Store below 25°C. Temperature excursions between 15°C to 25°C permitted.
Do not store EPIPEN in the fridge.
Store EPIPEN 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.
Extreme temperatures e.g. heat and dampness may cause the Auto-Injector unit to malfunction.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where children cannot accidentally reach it.
When to discard your medicine
After use, do not just throw away the EPIPEN Auto-Injector.
Continue to handle the EPIPEN Auto-Injector safely and with care. Do this even if
you think the EPIPEN Auto-Injector has not “triggered”, “fired” or worked properly.
You CANNOT RE-USE the EPIPEN Auto-Injector even though some adrenaline is left inside
it.
Give your used EPIPEN to the doctor, pharmacist or to a hospital. This is for inspection,
if required, and also for safe disposal. The used EPIPEN should be placed in a rigid
sharps disposal unit.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
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.
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
Serious side effects
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.
Accidental injection into the hands, fingers or feet may result in the following:
fast or noticeable heart beat
pale skin colour at the site of accidental injection
feeling of coldness at the site of accidental injection
bruising or discolouration at the site of accidental injection
bleeding
skeletal injury.
If an accidental injection occurs at one of these areas, seek medical attention immediately.
Injection related injuries, such as needle cuts and bent needles, have been reported
in people who are uncooperative and kick or move during the injection.
Rare cases of serious skin infections have been reported following injection into
the buttock. In case of signs or symptoms of injection site infection, such as swelling, persistent
redness, heat (warmth) or pain (tenderness) always seek medical help immediately.
Sodium metabisulfite
EPIPEN contains a very small quantity of sodium metabisulfite as a preservative. In
people who are allergic to sodium metabisulfite, this could cause, for example, severe
allergic reactions (hypersensitivity) or breathing difficulty (bronchospasm) in certain
groups of people, especially those with history of asthma. However, the active ingredient,
adrenaline, in EPIPEN is expected to overcome any allergic reaction to sodium metabisulfite.
In an emergency, the risk of exposure to the very small amount of sodium metabisulfite
is generally outweighed by the benefits of EPIPEN.
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 available with a doctor's prescription. You can also purchase it
directly from a pharmacy.
What EPIPEN contains
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Active ingredient
(main ingredient)
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Adrenaline (epinephrine) 300 micrograms in 0.3 mL
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Other ingredients
(inactive ingredients)
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sodium chloride
sodium metabisulfite
hydrochloric acid
Water for Injections
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Potential allergens
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Sulfites
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Consult your doctor or specialist if you are allergic to any of these ingredients.
What EPIPEN looks like
EPIPEN delivers one x 0.3 mL dose of adrenaline (epinephrine). This EPIPEN dose provides
300 micrograms of adrenaline (epinephrine) (AUST R 42978).
The EPIPEN Auto-Injector holds 2 mL of adrenaline (epinephrine) 1:1,000 solution.
The EPIPEN Auto-Injector is packed in a non-waterproof protective plastic carry tube.
This carry tube has a yellow cap. The carry tube is supplied in a cardboard pack.
Who distributes EPIPEN
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in April 2025.
EPIPEN® is a Viatris company trade mark.
Made in USA
EPIPEN_cmi\Apr25/00