Epipen Consumer Medicine Information

Adrenaline (Epinephrine) 0.3 mg/0.3 mL Auto-Injector

What is in this leaflet?

This leaflet 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 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 for

EpiPen is only for the immediate EMERGENCY TREATMENT of a SEVERE ALLERGIC REACTION (also known as ANAPHYLAXIS). Your doctor 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
  • latex or
  • 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.
  • brain.
    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.
  • helps stop
    • swelling, for example, of the face and lips
    • skin rash and/or
    • itching.

The EpiPen Auto-Injector is for people who weigh more than 30 kg and have 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 (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.

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.

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 practise using EpiPen BEFORE a severe allergic reaction causes a medical emergency.

Ask your doctor or pharmacist how you can get an "EpiPen Trainer" device to practise or demonstrate.

The "EpiPen Trainer" device

  • does not contain medicine (adrenaline, epinephrine) and
  • does not have a needle.

Otherwise it is the same as the real EpiPen. If you practise using the "EpiPen Trainer", you will learn how to use the real EpiPen.

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).

Take care also when giving EpiPen to those

  • having an anaesthetic

or who have:

  • diabetes
  • heart disease
  • allergy to EpiPen
  • brain damage.

You should tell your doctor if you have:

  • depression, or are on medication for depression
  • thyroid problems, or are on thyroid medication
  • heart disease or high blood pressure
  • diabetes
  • high pressure in the eye (narrow angle glaucoma)
  • asthma
  • 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"
  • thyroid hormone
  • medicines for diabetes
  • antihistamines.

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.

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. Symptoms do vary. However, the symptoms are likely to include:

  • collapse
  • difficulty in breathing
  • wheezing
  • swelling, especially of the face, lips, tongue or throat
  • skin rash, hives
  • itching.

How much to use

EpiPen delivers one measured dose of adrenaline (epinephrine). This dose is for a person who weighs more than 30 kg.

How to use it

General

  • Grip only the mid-section of the EpiPen Auto-Injector. Avoid touching either end, except when you remove the grey safety cap
  • 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.

Step 1

Carefully slide the EpiPen Auto-Injector out of its amber-coloured protective tube. Check the contents of the EpiPen Auto-Injector through the "viewing window". Make sure the solution is clear, colourless and sediment-free.

Step 2

Make a fist around the EpiPen Auto-Injector, with your thumb nearest to the grey safety cap.

Step 3

Activate the EpiPen Auto-Injector by removing the grey safety cap 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 grey safety cap do not touch the black tip. The hidden needle comes out of the black tip.

Step 4

Hold the EpiPen Auto-Injector at a 90 angle (right angle) to the fleshy upper outer part of the thigh. Either

  • hold the black tip about 5cm away from the thigh
  • place the black tip gently on the thigh.

Step 5

Firmly jab the black tip into the upper outer part of the upper thigh. Keep pressing the EpiPen Auto-Injector firmly against the thigh for several seconds (see FIGURE 3).

NOTE: EpiPen may be used either

  • through clothing, as shown in FIGURE 3, or
  • directly on to skin.

When you jab 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.

Step 6

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.

Step 7

Record the time EpiPen was given.

Step 8

Seek further medical attention for yourself immediately. Although you have received adrenaline (epinephrine) from EpiPen, you may need more medical treatment.

Either
  • Contact your doctor or
  • Call an ambulance (telephone 000 in Australia or 111 in New Zealand).
    State that adrenaline treatment may be needed.

NOTE: EpiPen is only for immediate emergency treatment of a severe allergic reaction. Further treatment is usually needed.

Step 9

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.

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,

  • consult your doctor immediately or
  • telephone the Poisons Information Centre (telephone 13 11 26 in Australia or 0800 POISON (0800 764 766) in New Zealand) for advice, or
  • go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. Urgent medical attention may be required.

Things to note about EpiPen

Things you must do

Check what the expiry date is on your EpiPen.

Mark this expiry date on your calendar or diary.

Replace your EpiPen prior to this expiry date.

Also note on your calendar or diary to check the contents of your EpiPen each month. Do this through the "viewing window".

Make sure the solution is clear, colourless and sediment-free. If not, obtain a new EpiPen immediately.

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 must not do

Do not use EpiPen

  • to treat any other medical conditions unless your doctor tells you to.
  • if the solution is brown or contains any particles or cloudiness.
  • in a child who weighs 15 kg to 30 kg. EpiPen Jr. is available for children who weigh 15 kg to 30 kg.
  • in a child who weighs less than 15 kg. Talk to your doctor if this is the case.

Do not take off the grey safety cap until you need to use EpiPen and are ready to use it. Remember that the EpiPen Auto-Injector is activated ("triggered", ready to "fire") as soon as you take off the grey safety cap.

Do not touch the black tip on any person or object while you are taking off the grey safety cap and/or after you have taken off the grey safety cap. The black tip holds the hidden needle, ready to "fire" and inject the adrenaline (epinephrine).

After you take off the grey safety cap

  • Do not "click" the outer end of the EpiPen Auto-Injector. The EpiPen Auto-Injector does not work like a retractable ball-point pen (see How to use it step 3).
  • Do not bump the EpiPen Auto-Injector until you intentionally jab the black tip into the thigh (see How to use it step 4).

Do not inject into hands, feet, ears, nose, buttocks, genital area or into a blood vessel. If this does happen accidentally you must immediately seek medical attention.

Side effects

Like all medicines, EpiPen can cause some side effects. Side effects not listed in this leaflet may occur in some patients.

Tell your doctor if you experience any unpleasant side effects after using EpiPen , even if you do not think the effect is connected with the medicine or is listed in this leaflet. Ask your doctor to answer any questions you may have.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Adrenaline (epinephrine)

Tell your doctor or pharmacist if you have any of the following:

  • fast or noticeable heart beat
  • difficulty breathing
  • shortness of breath
  • dizziness
  • pale skin colour
  • weakness
  • tremor
  • headache
  • throbbing
  • sweating
  • nausea or vomiting
  • sleeplessness
  • coldness
  • hallucinations
  • restlessness
  • anxiety
  • fear
  • flushing or redness of face and skin.

These side effects are minor and short lasting.

More severe side effects can occur occasionally. They are caused by adrenaline (epinephrine) stimulating the heart and increasing the blood pressure. Rarely, these side effects can cause, for example, a stroke, lung problems or severe irregular heartbeat.

Adrenaline (epinephrine) may also cause disorientation and impaired memory.

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 asthma. However, the active ingredient, adrenaline (epinephrine), 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.

Storing EpiPen before use

Always handle the EpiPen Auto-Injector carefully, so as not to accidentally activate it or make it "fire".

Storage

Keep EpiPen available with the person for whom it is intended.

Keep EpiPen in a cool dry place where the temperature stays below 25C.

Do not place EpiPen in the fridge.

Protect EpiPen from light. Keep EpiPen in the amber-coloured protective tube until required.

Do not store EpiPen or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill or in the car. Heat and dampness can destroy some medicines.

Keep EpiPen where children cannot accidentally reach it.

After using EpiPen

Disposal

After the EpiPen Auto-Injector has "fired", the needle is exposed. It could cause injury. After use, 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 (epinephrine) is left inside it.

After use, do not just throw away the EpiPen Auto-Injector.

  • Bend the exposed needle into a 'U' shape, so there is no sharp point. Do this by carefully pressing the needle against a suitable hard surface.
  • Slide your used EpiPen, black tip first, into its amber-coloured protective tube. Do not replace the grey safety cap.
  • Recap the protective tube.
  • Give your used EpiPen, in its protective tube, to the doctor. This is for inspection, if required, and also for safe disposal. The used EpiPen, in its protective tube, should be placed in a rigid sharps disposal unit.

Product description

Ingredients

EpiPen delivers one x 0.3 mL dose of adrenaline (epinephrine). This EpiPen dose provides 0.3 mg of adrenaline (epinephrine).

The EpiPen Auto-Injector holds 2 mL of adrenaline (epinephrine) 1:1,000 solution.

The injection also contains small amounts of

  • sodium chloride
  • sodium metabisulfite
  • hydrochloric acid.

It does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

The EpiPen Auto-Injector is packed in an amber-coloured safety container (protective tube). The container is supplied in a cardboard pack.

The Australian Registration Number is AUST R 42978.

This is not all the information available on EpiPen. If you have any more questions or are unsure about anything, ask your doctor or pharmacist.

Produced for DEY, Napa, CA, 94558
by Meridian Medical Technologies Inc., Columbia, MD, 21046, USA.

This leaflet was prepared in January 1998, and last amended September 2002.

EpiPen is a registered trademark of E. Merck, Darmstadt, Germany (parent company of EM Industries, Inc).

CSL 2002