EPIPEN AUTO-INJECTOR 0.3MG

Active substance: ADRENALINE

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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.

Diagram 2

Usual side effects include: irregular heartbeat (including
palpitations and rapid heartbeats), high blood pressure,
sweating, nausea, vomiting, difficulty breathing,
paleness, headache, dizziness, weakness, tremor and
apprehension, nervousness or anxiety.

4. Possible side effects
Like all medicines EpiPen® can cause side effects,
although not everybody gets them.

In rare cases cardiomyopathy has been seen in patients
treated with adrenaline.
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.

Accidental injection of the pens in hands or fingers
have been reported and may result in lack of blood
supply to these areas. In case of accidental
injection, always seek immediate medical help.

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.

Do not use EpiPen® after the expiry date which is stated
on the label.

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 reach and sight of children.

colourless. 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. Further Information
What EpiPen® contains
The active substance is adrenaline 0.3 mg
(300 microgram).
The other ingredients are: Sodium Chloride, Sodium
Metabisulphite, Hydrochloric Acid, Water for Injections.
What EpiPen® looks like and contents of the
pack
Clear and colourless solution in a pre-filled pen
(Auto-injector).
The Auto-injector (single-dose) contains 2 ml solution
for injection.
Marketing Authorisation Holder and
Manufacturer
Marketing authorisation holder:
Meda Pharmaceuticals Ltd, Skyway House, Parsonage
Road, Takeley, Bishop’s Stortford,
CM22 6PU
Manufacturer: MEDA Pharma GmbH & Co. KG,
Benzstrasse 1, 61352 Bad Homburg, Germany
This leaflet was last revised in June 2014.
For information in large print, tape, CD or Braille,
telephone 0800 1985000

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

56UK2065103-03

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Important information about some of the
ingredients of EpiPen®
EpiPen® contains sodium metabisulphite, 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.

still there and the doctor has told you that you can do
this. For this reason it may be a good idea to carry more
than one EpiPen® with you at all times.

34315C

COLOURS USED:
Black
PANTONE 116C
PANTONE 186 C

COUNTRY:

United Kingdom UK

LANGUAGE:

english

CORRECTION: 2.
DATE:

17. 06. 2014

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. Before you 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 30 kg (4 stone 9 lbs) as there is a greater risk of
getting side effects.
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.

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.
Warning
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.
Taking other medicines
When being prescribed EpiPen®, please tell your doctor
or pharmacist if you are taking, or have recently taken,
any other medicines, including medicines obtained
without a prescription as they may affect how the
adrenaline works.
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.
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.

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 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.
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 30 kg. For persons weighing
less than 30 kg (4 stone 9 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).

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.

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.

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.

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

Driving and using machines
The ability to drive and 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.

Sometimes a single dose of adrenaline may not be
sufficient to completely reverse the effects of an allergic
reaction. For this reason, your doctor may prescribe
more than one EpiPen® for you. Repeated injections may
be administered after 5-15 minutes if the symptoms are

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If you notice the signs of an acute allergic reaction, use
EpiPen® immediately, through your clothing if necessary.

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.
Diagram 1
Blue safety cap

EpiPen
Orange tip

1. Grasp EpiPen auto-injector in dominant hand,
with thumb closest to blue safety cap.
2. With the other hand pull off blue safety cap.
3. Hold the EpiPen® auto-injector at a distance of
approximately 10 cm away from the outer thigh, as
shown in diagram 2a. The orange tip should point
towards the outer thigh.
®

5

PATIENT INFORMATION LEAFLET
®

EpiPen Auto-Injector 0.3 mg
Adrenaline

Read all of this leaflet carefully before you start
using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
or pharmacist.
- This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In
1.
2.
3.
4.
5.
6.

this leaflet:
What EpiPen® is and what it is used for
Before you use EpiPen®
How to use EpiPen®
Possible side effects
How to store EpiPen®
Further information

1. What EpiPen® is and what it is used for
EpiPen® contains a sterile solution for emergency
injection into the 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.
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34315C

EpiPen® Expiry Date Alert Service

Expiry Date:
(see label)

Your Doctor’s Name:

Your Doctor’s Address:

Postal Code:

Tel No.:

It is important that your EpiPen® should be replaced before the expiry date marked on the label. For your safety and convenience,
Meda offers all patients prescribed EpiPen an expiry date alert service. We will contact you to remind you when you
need to replace your EpiPen. Please fill in the form below and return it to:
EpiPen Alert Service, Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishops Stortford, CM22 6PU.

EpiPen® Expiry Date Alert Form

Please print clearly in capital letters.

Lot No.:
(see label)

Your Full Name:

Your Mailing Address:

Postal Code:

Please remember to inform us if you change address.

4. Jab firmly into the outer thigh so that the EpiPen®
auto-injector is at a right angle (at a 90 degree
angle) to the outer thigh, as shown in diagram 2b
(listen for click).
5. Hold firmly in place for 10 seconds. The injection is
now complete and the window of the auto-injector
is obscured. The EpiPen® autoinjector should be
removed (orange needle cover will extend to cover
needle) and safely discarded.
6. Massage the injection area for 10 seconds.

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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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