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EPIPEN AUTO-INJECTOR 0.3MG

Active substance(s): ADRENALINE

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34315D

EpiPen® Expiry Date Alert Service

It is important that your EpiPen® should be replaced before the expiry date marked on the label. For your safety a nd 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.: Expiry Date:
(see label) (see label)

Your Full Name: Your Doctor’s Name:

Your Mailing Address: Your Doctor’s Address:

Postal Code: Postal Code:

Please remember to inform us if you change address. Tel No.:

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.

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 t­ rying to p
­ rotect 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 m
­ uscles 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.

6. Contents of the Pack and Other
­Information
What EpiPen® contains
The active substance is adrenaline 0.3 mg
(300 microgram).
The other ingredients are: Sodium Chloride,
Sodium Metabisulphite (E223), 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. Each auto-injector delivers
one single dose (0.3 ml) of adrenaline.
The exposed needle length is approximately
16 mm for EpiPen.

2. W
 hat you need to know before you use
EpiPen®

Marketing Authorisation Holder and
­Manufacturer

Do not use EpiPen®
There is no known reason why anyone should not
use EpiPen® during an allergic emergency.

Marketing authorisation holder:
Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishops Stortford,
CM22 6PU
Manufacturer: MEDA Pharma GmbH & Co. KG,
Benzstrasse 1, 61352 Bad Homburg, Germany
This leaflet was last revised in February 2016
If this leaflet is difficult to see or read and you
would like it in a different format, please contact
Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishops Stortford,
CM22 6PU, United Kingdom.

34315D
56UK2065103-05

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EpiPen® Auto-Injector 0.3 mg
Adrenaline
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.

5. How To Store EpiPen®
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label and carton. The
expiry date refers to the last day of that month.
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 discoloured or
contains a precipitate (solid particles).
Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to
throw away medicines you no longer use.
These measures will help protect the
­environment.
See also section 3 – Directions for use.

5

PATIENT INFORMATION LEAFLET

6

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
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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.
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-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 (theophylline)
• Medicines used in labour (oxytocin)
• Medicines used to treat allergies such as
diphenhydramine or chlorpheniramine
(antihistamines)
• 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 d
­ uring 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 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.
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’.

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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.
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 p
­ rescribe 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 buttocks
(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.

Blue safety cap

Orange tip

3

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)
2. With 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
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 on the autoinjector 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.

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.

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03.02.16 10:05

Studio Oberländer GmbH · Rubensstr.  33 · 60596 Frankfurt a. M. · Germany
Phone: +49 69 631520-85  ·  Fax: -87  ·  E-Mail: info@studio-oberlaender.de

SPECIFICATION BOX: Leaflet
MANUFACTURER: Meda Pharma GmbH & Co. KG

COLOURS USED:

PRODUCT: EpiPen 2 – Senior 0,3 mg

Cyan



Magenta

MEDA-NO.: 56UK2065103-05

Yellow

MFS-NO.:
34315D

Black

PHARMA-CODE:

Pantone 116

34315D

34315D

Pantone 186
COUNTRY:

United Kingdom

UK

LANGUAGE: English
PACK SIZE:

280 x 324 mm

CORRECTION: 3.

FONT SIZE:

8 pt / 9 pt

DATE:

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03 02. 2016

03.02.16 10:05

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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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