EPIPEN JR. AUTO-INJECTOR 0.15MG

Active substance: ADRENALINE

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If you use more EpiPen® Jr. 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® Jr. can cause side effects,
although not everybody gets them.

In rare cases cardiomyopathy has been seen in patients
treated with adrenaline.
As the EpiPen® Jr. is designed as emergency treatment
only, you should always seek medical help
immediately after using EpiPen® Jr., 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 Jr.
Auto-injector. It does not affect the way the
product works.
Even though most of the liquid (about 90%) remains in
the EpiPen® Jr. 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® Jr. safely in the tube
provided and bring it with you when you visit your
doctor, hospital or pharmacy.
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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® Jr. contains
The active substance is adrenaline 0.15 mg
(150 microgram).
The other ingredients are: Sodium Chloride, Sodium
Metabisulphite, Hydrochloric Acid, Water for Injections.
What EpiPen® Jr. looks like and contents of the pack

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.

Clear and colourless solution in a pre-filled pen
(Auto-injector).
The Auto-injector (single-dose) contains 2 ml solution
for injection.

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.

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

5. How To Store EpiPen® Jr.
Keep out of the reach and sight of children.
Do not use EpiPen Jr. after the expiry date which is
stated on the label.
®

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® Jr. Auto-injector from
time to time to make sure the liquid is still clear and

PANTONE 376 C
PANTONE 186 C

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® Jr. 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® Jr. 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®Jr.
There is no known reason why anyone should not use
EpiPen® Jr. during an allergic emergency.
Take special care with EpiPen Jr.
Adrenaline is essential for the treatment of anaphylaxis.
However, take special care with EpiPen® Jr.:
• 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 administering EpiPen® Jr. to patients who
weigh less than 15 kg (2 stone 5 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® Jr. 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® Jr. 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
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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.
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® Jr., 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® Jr. 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® Jr. 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.
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Important information about some of the
ingredients of EpiPen® Jr.
EpiPen® Jr. contains sodium metabisulphite, which may
arely cause severe allergic reactions (hypersensitivity) or
breathing difficulty (bronchospasm). However, you
should still use the EpiPen® Jr. as there are no satisfactory
alternatives.

3. How to use EpiPen® Jr.
When your doctor prescribes EpiPen® Jr., 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® Jr. 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.

symptoms are 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® Jr. with you at
all times.
Method of administration
The EpiPen® Jr. is designed to be used easily by people
without medical training. EpiPen® Jr. 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® Jr. 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® Jr. can be injected
through the clothes.

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.

The instructions for use of the EpiPen® Jr. given below
must be carefully followed.

EpiPen® Jr. is intended to be used by children with a body
weight between 15-30 kg (2 stone 5 lbs – 4 stones 9 lbs).
For persons weighing more than 30 kg (4 stone 9 lbs)
EpiPen® may be more appropriate for use.

Directions for use
Before you ever need to use it, fully familiarise yourself
with the EpiPen® Jr., when and how it should be used
(refer to diagram 1).

Dosage
The dose will be decided by your doctor, who will adjust
it individually for you. The usual dose for children is
0.15 mg or 0.3 mg adrenaline for intramuscular
injection depending on the body weight of the patient
(0.01 mg/kg body weight).
If you notice the signs of an acute allergic reaction, use
EpiPen® Jr. immediately, through your clothing if
necessary.
Each EpiPen® Jr. Auto-injector delivers one single dose of
0.3 ml liquid which is equal to 0.15 mg (150 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 an allergic
reaction. For this reason, your doctor may prescribe
more than one EpiPen® Jr. for you. Repeated injections
may be administered after 5-15 minutes if the
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EpiPen Jr. Auto-Injector 0.15 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® Jr. is and what it is used for
Before you use EpiPen® Jr.
How to use EpiPen® Jr.
Possible side effects
How to store EpiPen® Jr.
Further information

1. What EpiPen® Jr. is and what it is used for
EpiPen® Jr. contains a sterile solution for emergency
injection into the muscle (intramuscular injection).
EpiPen® Jr. 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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Black

COUNTRY:

PATIENT INFORMATION LEAFLET
®

56UK2065203-03

34442C

COLOURS USED:

34442C

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

EpiPen® Jr. Expiry Date Alert Form

Plse 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® Jr.
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® Jr. auto-injector should be
removed (orange needle cover will extend to
cover needle) and safely discarded.
6. Massage the injection area for 10 seconds.

EpiPen® Jr. should only be injected into the outer thigh.
It should not be injected into the buttock
(your bottom).

Follow these directions only when ready to use.
Hold the EpiPen® Jr. by the middle, never by the ends.
For proper administration, look at the diagrams and
EpiPen
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® Jr. 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® Jr. 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.
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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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