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EPIPEN 0.3MG AUTO-INJECTOR

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Assessed against UK PIL dated January 2009

27mm

This product is available as 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.
- 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.

Leaflet Flat Size = 148 x 432
PROOF HISTORY:
v.2 - waymade - 17/8/09

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

In this leaflet:
1. What EpiPen is and what it is used for
2. Before you use EpiPen
3. How to use EpiPen

4. Possible side effects
5. How to store EpiPen
6. 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.
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.

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
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 9lbs) 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.

DATE:

CUSTOMER
APPROVED:

2. BEFORE YOU USE EPIPEN
There is no known reason why anyone should not use EpiPen during an allergic emergency.

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.

ks

DATE OF PROOF:

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.

17/8//09

ARTWORKER:

DATE:

04-1957
PRE-PRESS NO.:

Q.A.
APPROVED:

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.

6464/2727 B
CODE:

Epipen 0.3mg
PRODUCT:

CUSTOMER: Waymade

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 your 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.
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.
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 30Kg. For persons weighing less than 30
kg (4 stone 9lbs), 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 the 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 0.3mg (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 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 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.

WARNING!

Patient Information Leaflet

WARNING!

EPIPEN 0.3mg AUTO-INJECTOR
Adrenaline (Epinephrine)

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000B

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

By potrickn at 9:16 am, Aug 26, 2009

1. Grasp EpiPen in dominant hand (the hand you use to write), with thumb nearest grey cap and form fist
around unit (black tip down).
2. With other hand pull off grey safety cap.
3. Hold the EpiPen at a distance of approximately 10 cm (4 inches) away from the outer thigh, as shown in
diagram 2a. The black tip should point towards the outer thigh.
4. Jab the Epipen firmly into the outer thigh at a right angle (90 degree angle) as shown in diagram 2b.
(listen for click)
5. Hold firmly in thigh for 10 seconds. EpiPen should be removed and safely discarded.
6. Massage the injection area for 10 seconds.
Diagram 2

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. After use,
place the EpiPen safely in the tube provided and bring it with you when you visit your doctor, hospital or
pharmacy.
DATE:

As the EpiPen is designed as emergency treatment only, you should always seek medical help
immediately after using EpiPen , by reporting to your doctor, nearest hospital or by calling an
ambulance. 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.

DATE:

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.

17/8/09

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.

DATE OF PROOF:

5. HOW TO STORE EPIPEN
Epipen 0.3mg should not be stored above 25 C. Protect from light. Do not refrigerate or freeze.
Keep the auto injector in the outer carton.
Replace the EpiPen before the expiry date, or if at any time the solution becomes coloured or
contains visible particles. Discard it safely after use in the tube provided.
Do not use after the expiry date printed on the carton or Epipen 0.3mg.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
If your doctor tells you to stop taking the injection, please take them back to the pharmacist for safe
disposal. Only keep the injection if your doctor tells you to.
See also section 3 - Directions for use.
6464/2727 B

ks

4. POSSIBLE SIDE EFFECTS
Like all medicines EpiPen can cause side effects, although not everybody gets them.
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.

CODE:

PRE-PRESS NO.:

ARTWORKER:
Epipen 0.3mg

CUSTOMER: Waymade

PRODUCT:

04-1957

Q.A.
APPROVED:

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.

6. FURTHER INFORMATION
Composition: What is in Epipen?
Your medicine is called Epipen 0.3mg Auto-injector. The Auto-injector contains 2ml of a clear and
colourless solution for injection in a pre-filled pen. For emergency intramuscular injection only.
Epipen 0.3mg Auto-injector also contains the following inactive ingredients:
sodium chloride, sodium metabisulphite, hydrochloric acid and water for injections.
What is Epipen?
Epipen 0.3mg Auto-injector is a sterile solution for intramuscular injection. Each Epipen 0.3mg Auto- Injector
delivers one single dose of 0.3ml liquid, which is equal to 0.3mg of adrenaline.
Please note that not all the content of the Auto-Injector is injected 1.7ml (about 90%) remains in the
Auto-Injector after use.
A single Pack Epipen 1 Auto-injector.
A small air bubble may occur in the EpiPen Auto-Injector. It has no influence on either the use of the product
or efficacy.
POM

PL No: 06464/2727

This product is manufactured by Meridian Medical Technologies Inc., 2550 Hermelin Drive, St. Louis,
Missouri, USA and procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 14.8.2009
Epipen is a registered trademark of ALK-Abello.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Diagram 1

WARNING!

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 black tip.

Do not remove grey safety cap until ready to use.

WARNING!

Leaflet Flat Size = 148 x 432

CUSTOMER
APPROVED:

PROOF HISTORY:
v.2 - waymade - 17/8//09

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

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).

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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.

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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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