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EPIPEN AUTO-INJECTOR 0.3 MG

Active substance(s): ADRENALINE / ADRENALINE / ADRENALINE

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PATIENT INFORMATION LEAFLET

2727
16.06.16[3]

EpiPen® Auto-Injector 0.3 mg
(adrenaline)
Your medicine is available using the above name but will be referred to as
EpiPen throughout this leaflet.
Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section
4.

This is especially important if you take any of the following:
Antidepressants such as tricyclic antidepressants or monoamine oxidase
inhibitors (MAO inhibitors), since the effects of adrenaline may be
increased.
Medicines that may make the heart sensitive to uneven beats
(arrhythmias), such as digitalis, mercurial diuretics or quinidine.

 Medicines for the treatment of Parkinson’s disease such as catechol-O-

Blue safety cap

Orange tip

methyl transferase inhibitors (COMT inhibitors) and levodopa since the
effect of adrenaline may be increased

 Beta-blocking medicines for heart disease or medicines to treat
disorders of the nervous system as they can reduce the effect of
adrenaline

 Medicines for thyroid disease
 Medicines that make you breathe more easily; used for asthma

Diagram 1
1. Grasp EpiPen in dominant hand (the
hand you use to write), with thumb
nearest blue cap and form fist around unit
(orange tip down)

(theophylline)

 Medicines used in labour (oxytocin)
 Medicines used to treat allergies such as diphenhydramine or
chlorpheniramine (antihistamines)

What is in this leaflet:
1. What EpiPen is and what it is used for
2. What you need to know before you use EpiPen
3. How to use EpiPen
4. Possible side effects
5. How to store EpiPen
6. Contents of the pack and other information
1. What EpiPen is and what it is used for
EpiPen contains a sterile solution of adrenaline for emergency injection
into the outer part of the thigh muscle (intramuscular injection).
EpiPen is to be used for the emergency treatment of sudden life
threatening allergic reactions (anaphylactic shock) to insect stings or
bites, foods or drugs or exercise. The reaction is the result of the body
trying to protect itself from the allergen (the foreign substance that causes
the allergy) by releasing chemicals into the blood stream. Sometimes the
cause of the allergic reaction is not known.
Symptoms that signal the onset of an anaphylactic shock occur within
minutes of exposure to the allergen and include: itching of the skin; raised
rash (like a nettle rash); flushing; swelling of the lips, throat, tongue,
hands and feet; wheezing; hoarseness; shortness of breath; nausea;
vomiting; stomach cramps and in some cases, loss of consciousness.
The medicine in the Auto-injector (the pen) is adrenaline which is an
adrenergic drug.
It works directly on the cardiovascular (heart and circulation) system and
respiratory (lung) system, to stop the possible fatal effects of anaphylactic
shock by very quickly making the blood vessels smaller, relaxing muscles
in the lungs to improve breathing, reducing swelling and stimulating
heartbeat.
The EpiPen is intended for immediate self administration by a person with
a history or recognised risk of going into anaphylactic shock. If you are at
risk, you should always keep your EpiPen with you. It is designed as an
emergency rescue therapy but you must get medical attention as soon as
possible after its use.
2. What you need to know before you use EpiPen
Do not use EpiPen
There is no known reason why anyone should not use EpiPen during an
allergic emergency.
Take special care with EpiPen
Adrenaline is essential for the treatment of anaphylaxis. However, take
special care with EpiPen:












particularly if you have heart disease as it may affect the medicines that
you are taking and may bring on an attack of chest pain (angina)
if you have an overactive thyroid
if you have high blood pressure
if you have diabetes
If you are elderly, pregnant or the child weighs less than 25 kg (3 stone
13 lbs) as there is a greater risk of getting side effects.
if you have increased pressure in your eye(s) (glaucoma)
if you have severe kidney problems
if you have a tumour in your prostrate
if you have high calcium levels or a low potassium level in your blood
if you have Parkinson’s disease

Make sure you have discussed this with your doctor if any of these apply
to you.
Patients with these conditions, or anyone who may be in the position to
administer EpiPen to a patient having an allergic reaction, should be
properly instructed on how and when to give it.

The instructions for use must be carefully followed in order to avoid
accidental injection.
EpiPen should only be injected into the outer thigh.
It should not be injected into the buttock due to the risk of accidental
injection into a vein.
Warnings and precautions
If you have asthma you may be at increased risk of severe allergic
reaction. Anyone who has an episode of anaphylaxis should see their
doctor about testing for substances they may be allergic to, so these can
be strictly avoided in future. It is important to be aware that an allergy to
one substance can lead to allergies to a number of related substances. If
you have food allergies it is important to check the ingredients in
everything you ingest (including medicines) as even small amounts can
cause severe reactions.
Accidental injection into the hands or fingers may result in reduced blood
supply to these areas. If there is an accidental injection into these areas,
you should go immediately to the nearest hospital casualty department for
treatment.
If you have a thick-subcutaneous fat layer, there is a risk for the
adrenaline not reaching the muscle tissue resulting in a suboptimal effect.
Other medicines and EpiPen
When being prescribed EpiPen, please tell your doctor or pharmacist if
you are taking, have recently taken or might take, any other medicines,
including medicines obtained without a prescription as they may affect
how the adrenaline works.

 Medicines that act on the nervous system (parasympatholytics).
Diabetic patients should carefully monitor their glucose levels after use of
EpiPen as adrenaline can reduce the amount of insulin made by the
body, thus increasing the blood glucose level.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
There is limited experience of the use of adrenaline during pregnancy. If
you are pregnant, do not hesitate to use EpiPen in an emergency, since
you and your baby’s lives may be in danger. Discuss this with your doctor
if you are pregnant.
Driving and using machines
The ability to drive or use machines is unlikely to be affected by the
administration of an adrenaline injection but may be affected by an
anaphylactic reaction. If affected do not drive.
EpiPen contains
EpiPen contains sodium metabisulphite (E223), which may rarely cause
severe allergic reactions (hypersensitivity) or breathing difficulty
(bronchospasm). However, you should still use the EpiPen as there are
no satisfactory alternatives.
This medicine contains less than 23 mg sodium per dose, i.e. essentially
‘sodium-free’.
3. How to use EpiPen
When your doctor prescribes EpiPen, you must make sure you
understand the reason it has been prescribed for you. You should be
confident that you know exactly how and when to use it. Always use
EpiPen exactly as your doctor or pharmacist has told you. If you are at all
unsure about how to use it, ask to have the instructions repeated by your
doctor, nurse or pharmacist.
It is recommended that your family members, carers or teachers are also
instructed in the correct use of EpiPen

2. With the other hand pull off blue safety
cap.
3. Hold the EpiPen at a distance of
approximately 10 cm away from the outer
thigh. The orange tip should point
towards the outer thigh.

4. Jab the EpiPen firmly into the outer thigh
at a right angle (90 degree angle) (listen
for click).
5. Hold firmly against thigh for 10 seconds.
The injection is now complete and the
window of the auto-injector is obscured.

6. EpiPen should be removed (the orange
needle cover will extend to cover needle)
and safely discarded.
7. Massage the injection area for 10
seconds. Dial 999, ask for ambulance,
and state anaphylaxis.

If you have been stung by an insect, try to remove the stinger with your
fingernails – do not squeeze, pinch or push it deeper into the skin. If
possible, put an ice pack on the area of the sting. Keep warm and avoid
exercise. For allergic reactions caused by foods make sure you remove
any remaining food from the mouth immediately.
EpiPen is intended to be used by people with a body weight above 25 kg
(3 stone 13 lbs). For persons weighing less than 25 kg (3 stone 13 lbs)
EpiPen Jr. may be more appropriate for use.
Dosage
The dose will be decided by your doctor, who will adjust it individually for
you. The usual adult dose for allergic emergencies is 0.3 mg adrenaline
for injection into muscle (intramuscular use).
If you notice the signs of an acute allergic reaction, use EpiPen
immediately, through your clothing if necessary.
Each EpiPen Auto-injector delivers one single dose of 0.3 ml liquid which
is equal to 0.3 mg (300 micrograms) adrenaline. After use a volume of 1.7
ml will remain in the Auto-injector but this cannot be reused.
Sometimes a single dose of adrenaline may not be sufficient to
completely reverse the effects of a serious allergic reaction. For this
reason, your doctor is likely to prescribe more than one EpiPen for you. If
your symptoms have not improved or have deteriorated within 5-15
minutes after the first injection, either you or the person with you should
give a second injection.
For this reason you should carry more than one EpiPen with you at all
times.
Method of administration
The EpiPen is designed to be used easily by people without medical
training. EpiPen should simply be jabbed firmly against the outer portion
of the thigh from a distance of approximately 10 cm (4 inches). There is
no need for precise placement in the outer portion of the thigh. When you
jab the EpiPen firmly into your thigh, a spring activated plunger will be
released, which pushes the hidden needle into the thigh muscle and
administers a dose of adrenaline. If you are wearing clothes the EpiPen
can be injected through the clothes.
The instructions for use of the EpiPen given below must be carefully
followed.
EpiPen should only be injected into the outer thigh.
It should not be injected into the buttock (your bottom).
Directions for use
Before you ever need to use it, fully familiarise yourself with the EpiPen,
when and how it should be used (refer to diagram 1).
Follow these directions only when ready to use.
Hold the EpiPen by the middle, never by the ends.
For proper administration, look at the diagrams and follow these steps:
 Never put thumb, fingers or hand over the orange tip.
 Do not remove blue safety cap until ready to use.

As the EpiPen is designed as emergency treatment only, you should
always seek medical help immediately after using EpiPen, by
dialling 999, ask for ambulance and state 'anaphylaxis' even if
symptoms appear to be improving. You 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.
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.
Make sure that you inform the healthcare professional that you have
received an intramuscular injection of adrenaline or show them the
container and/or leaflet.
A small air bubble may be present in the EpiPen Auto-injector. It does not
affect the way the product works.
Even though most of the liquid (about 90%) remains in the EpiPen after
use, it cannot be reused. However, you have received the correct dose of
the medication if the orange needle tip is extended and the window is
obscured.
After use, place the EpiPen safely in the tube provided and bring it with
you when you visit your doctor, hospital or pharmacy.
If you use more EpiPen than you should
In case of overdose or accidental injection of the adrenaline, you should
always seek immediate medical help. Your blood pressure may rise
sharply and it will need to be monitored.
If you have any further questions on the use of this medicine; ask your
doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines this medicine can cause side effects, although not
everybody gets them.
Seek urgent medical advice immediately in case of accidental injection.
Accidental injection of the pens in hands or fingers have been reported
and may result in lack of blood supply to these areas.
Tell your doctor or pharmacist if any of the following side effects occur or
worsen.
Not known (frequency cannot be estimated from the available data):
Usual side effects include: irregular heartbeat (including palpitations and
rapid heartbeats), high blood pressure, sweating, nausea, vomiting,
difficulty breathing, paleness, headache, hypertension, dizziness,
weakness, tremor and apprehension, nervousness or anxiety.
Rare (may affect up to 1 in 1,000 people)
Cardiomyopathy has been seen in patients treated with adrenaline.
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 EpiPen

 Keep out of the sight and reach of children.
 Do not use EpiPen after the expiry date which is stated on the label.
 Do not store above 25°C. Do not refrigerate or freeze.
 Keep container in the outer carton in order to protect from light. When
exposed to air or light, adrenaline deteriorates rapidly and will become
pink or brown. Please remember to check the contents of the glass
cartridge in the EpiPen Auto-injector from time to time to make
sure the liquid is still clear and colourless. Do not use this
medicine if you notice that the liquid is unclear, coloured or
contains solid particles. Replace the Auto-injector by the expiry
date or earlier if the solution is dis-coloured or contains a
precipitate (solid particles).

 Medicines should not be disposed of via drains or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

 See also section 3 - Directions for use.
6. Contents of the pack and other information
What EpiPen contains
The active substance is adrenaline 0.3 mg (300 microgram).
Each dosage (0.3ml) contains the active ingredient, adrenaline 0.3mg.
Excipients: sodium chloride, sodium metabisulphite (E223), hydrochloric
acid (pH adjustment), water for injections.
What EpiPen looks like and contents of the pack
Clear and colourless solution in a pre-filled pen (Auto-injector).
The immediate container/closure system contains an orange tip and blue
safety cap and is contained in a plastic casing. A glass cartridge contains
the solution. Each Auto-Injector delivers one single dose (0.3 ml) of
0.3 mg Adrenaline. The Auto-injector (single-dose) contains 2 ml solution
for injection.
Pack-sizes: 1 Auto-Injector and 2 Auto-Injectors
Manufacturer and Product Licence holder
Manufactured by MEDA Pharma GmbH & Co. KG, Benzstrasse 1,
D-61352 Bad Homburg, Germany.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2727

Leaflet revision and issue date (Ref.) 16.06.16[3]
EpiPen is a trademark of Mylan Inc., USA

Expand Transcript

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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