Important Consumer Medicine Information
This leaflet below answers some common questions about EpiPen® Adrenaline (epinephrine) Auto-Injector. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you receiving EpiPen® against the benefits this medicine is expected to have for you.If you have any concerns about receiving this medicine, talk to your doctor or pharmacist before there is a situation where EpiPen® is needed.
Please read this leaflet carefully before an emergency arises.
Keep this leaflet safely, with the EpiPen® Auto-Injector. You will probably want to read it again.
What EpiPen® is used forEpiPen® is only 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
other allergens, possibly unidentified.
See Side effects for information regarding allergy to sodium metabisulfite.Avoidance of known allergens is most important in preventing severe allergic reactions.
A severe allergic reaction is overwhelming and life-threatening.It affects the whole body, in particular the
heart and blood circulation.
This may cause, for example, low blood pressure and collapse, or abnormal heart beat 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 and diarrhoea, 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.
There may be fits or confusion due to lack of oxygen.
Usually several parts of the body are affected. The patient feels extremely unwell.It is important to act quickly to treat a severe allergic reaction.The adrenaline (epinephrine) in EpiPen® treats allergic emergencies. It
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 (epinephrine) also
relaxes the lungs. This eases breathing and lessens wheezing.
– swelling, for example, of the face and lips
– skin rash and/or
The EpiPen® Auto-Injector is intended for use in people who have been assessed and advised by their doctor as needing an EpiPen®Auto-Injector to treat their severe allergic reaction and who
weigh more than 30 kg, and
are having a severe allergic reaction.
Note: For a child who weighs from 15kg up to 30kg, the doctor may assess their severe allergic reaction as needing the larger dosage of adrenaline (epinephrine) as provided by an EpiPen® Auto-Injector. (The EpiPen® Jr. Auto-Injector delivers a smaller amount of adrenaline (epinephrine)).If you have any questions about this, talk to your doctor.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 (epinephrine)
is for single use only.
EpiPen® may be prescribed by your doctor. You can also purchase it directly from a pharmacy.Before you use EpiPen®The EpiPen® Auto-Injector is simple to use. Please read and follow the step-by-step instructions.Do not remove the grey safety release until you need to use EpiPen® and are ready to use it. The safety release stops EpiPen®from “firing” or working.
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.When you must not use it
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.The EpiPen® Auto-Injector has a clear “viewing window” so you can see the contents.
Do not use EpiPen® if the contents
are cloudy or
are coloured or
contain sediment or
if the “viewing window” shows red.
When the “viewing window” shows red, the auto-injector has already “fired” and cannot be used again.
Check your EpiPen® regularly (see Things you must do).Do not use EpiPen®
after the expiry date on the EpiPen® Auto-Injector and carton or
if the packaging is torn, doesn’t look quite right or shows signs of tampering.
If the EpiPen® packaging is damaged or it is past the expiry date, return it to your pharmacist for disposal.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® Trainer” device for practice.
An EpiPen® Trainer device is similar to the real EpiPen®. However, the EpiPen® Trainer has
NO medicine (adrenaline, epinephrine) and
NO needle and
“fires” quietly and less forcefully.
Ask your doctor or pharmacist to show you how to practice with the EpiPen® Trainer. If you practice using the EpiPen® Trainer, 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® Trainer 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
high pressure in the eye (narrow-angle glaucoma).
Take care also when giving EpiPen® to those
having an anaesthetic
or who have:
allergy to EpiPen®
You should tell your doctor or pharmacist if you have:
depression, or are on medication for depression
thyroid problems, or are on thyroid medication
heart disease or high blood pressure
high pressure in the eye (narrow angle glaucoma)
ever had an allergic reaction to sodium metabisulfite.
Taking other medicines
Tell your doctor or pharmacist if you are taking other medicines, including any medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with EpiPen®including:
medicines for high blood pressure, especially those known as “beta-blockers”, and other medicines for heart problems
medicines for depression, especially “tricyclic antidepressants”
medicines for diabetes
These medicines may affect how well the adrenaline (epinephrine) in EpiPen® works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.You should discuss any concerns you have with your doctor or pharmacist.How to use EpiPen®It is important to know how to use your EpiPen® in an emergency (see Help in using 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.When to use it
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:
difficulty in breathing
swelling, especially of the face, lips, tongue or throat
skin rash, hives
How much to use
EpiPen® Auto-Injector delivers one measured dose of adrenaline (epinephrine). This dose is for a person who weighs more than 30 kg and has been assessed by their doctor as needing EpiPen®.
Your doctor may also advise Epipen® Auto-Injector for a child who weighs from 15kg up to 30kg.
NOTE: Unless otherwise advised by the doctor, EpiPen® Jr. Auto-Injector should be used for children who weigh from 15 kg up to 30 kg.
See also “What EpiPen® is used for” above.
How to use it
Grip only the mid-section of the EpiPen® Auto-Injector. Avoid touching either end, except when you remove the grey safety release. The grey safety release stops the EpiPen® from “firing” or working.
Never place thumb, fingers or hand over the black tip as this contains the needle.
Always point the black tip (which holds the needle) away from any part of any body, except the planned injection site. This is usually the thigh of the person who has the severe allergic reaction.
Keep EpiPen® away from the face and eyes.
Carefully follow the step-by-step directions to make the EpiPen® work properly.
Unscrew the yellow cap on the protective carry tube. Carefully slide the EpiPen® Auto-Injector out of the carry tube. Never place thumb, fingers or hand over the black tip as this contains the needle. Check the contents of the EpiPen® Auto-Injector through the “viewing window”. Make sure the solution is clear, colourless and sediment-free. If the “viewing window” shows red, the EpiPen® has already “fired” and cannot be used again.
Make a fist around the EpiPen® Auto-Injector, with your thumb nearest to the grey safety release.
Activate the EpiPen® Auto-Injector by removing the grey safety release with your other hand. 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 grey safety release do not touch or place thumb, fingers or hand over the black tip as this contains the needle.
Hold the EpiPen® Auto-Injector at a 90° angle (right angle) to the fleshy upper outer part of the thigh. Hold the black tip about 5cm away from the thigh (see FIGURE 2).
Jab the black tip HARD into the upper outer part of the upper thigh until a “click” is heard or felt. Keep pressing the EpiPen® Auto-Injector firmly against the thigh for approximately 3 seconds.
NOTE: EpiPen® may be used either
through clothing, or
directly on to skin.
When you press the black tip of the EpiPen® Auto-Injector firmly against the thigh, the hidden needle “fires”. It injects the measured dose of adrenaline (epinephrine) into the thigh muscle.
Carefully take the EpiPen® Auto-Injector away from the thigh.Do not touch the needle which now sticks out of the black tip.
Gently rub the thigh in the area of the injection for about 10 seconds.Check the “viewing window” – it should now show red. If it does not show red, the EpiPen® has not “fired” or worked. If the “viewing window” does not show red, repeat steps 2-6 above.
Record the time EpiPen® was given.
Seek further medical attention for yourself immediately. Although you have received adrenaline (epinephrine) from EpiPen®, you may need more medical treatment.
Contact your doctor or
Call an ambulance (telephone 000 in Australia or 111 in New Zealand).State that adrenaline (epinephrine) treatment may be needed.
NOTE: EpiPen® is only for immediate emergency treatment of a severe allergic reaction. Further treatment is usually needed.
Explain to the doctor that you have had EpiPen® (intramuscular adrenaline (epinephrine)).Take your used EpiPen® Auto-Injector with you.To avoid injury, follow the used EpiPen® disposal instructions below (see Disposal).Additional information about treatment of insect sting allergy
Use EpiPen® immediately if you have been stung 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 (overdose)
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 you or anyone else may have used too much of this medicine,<
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