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EPIPEN (ADRENALINE) AUTO-INJECTOR 0.3 MG

Active substance(s): ADRENALINE

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S0592-1-CZ-PIL-11.03.2016

PACKAGE LEAFLET: INFORMATION FOR THE USER
EpiPen® (Adrenaline)
Auto-Injector 0.3 mg
Your medicine is available using the above name, but will be
referred to as EpiPen® throughout the remainder of 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.
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.

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-Omethyl 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 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 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’.

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.

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.

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.

Warnings and precautions

Method of administration

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.

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.

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.

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

The instructions for use must be carefully followed in order to
avoid accidental injection.

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.

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

Directions for use

Reporting of side effects

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

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.

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.

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.

5. How to store EpiPen®
Keep out of the sight and reach of children.
EpiPen® should not be used after the expiry date which is stated on the
pack.
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. 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 wastewater 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.
If your medicine becomes discoloured or shows any signs of
deterioration, you should seek the advice of your pharmacist.

6. Contents of the pack and other information
What EpiPen contains
One dosage (0.3ml) contains:
Active ingredient: adrenaline 0.3mg (300 micrograms)
Excipients: sodium chloride, sodium metabisulfite, hydrochloric acid
35%, water for injections.
4. Jab the EpiPen firmly into outer thigh at a right
angle (90 degree angle) (listen for click).

What EpiPen® looks like and contents of the pack

5. Hold firmly against thigh for 10 seconds. The
injection is now complete and the window on the
autoinjector is obscured.

Clear and colourless solution in a pre-filled pen (Auto-injector).
The Auto-injector (single-dose) contains 2ml solution for injection. Every
Auto-injector deliver a single dose (0.3ml) of 0.3mg adrenaline when
activated. After activation of the Auto-Injector 1.7ml remains in the AutoInjector. The exposed needle length is approximately 16 mm for EpiPen.
The pack contains 1 Auto Injector.

6. EpiPen should be removed (the orange needle
cover will extend to cover needle) and safely
discarded.

Manufactured by: MEDA Pharma GmbH & Co. KG
Benzstrasse 1
D-61352 Bad Homburg
Germany

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.

Procured from within the EU and repackaged by: Amimed Direct Ltd,
Hendon, London, NW9 6AQ. Product Licence Holder: Sam Pharma
Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9
6AQ.
POM

PL 33902/0592

Leaflet revision date: 11/03/2016
EpiPen® is a registered trademark of Mylan Inc., USA.
S0592-1-CZ-PIL-11.03.2016
S0592-CZ-PIL-13.08.2015

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.

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 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) __________________________________________
Expiry Date: (see label) _______________________________________
Your Full Name: ____________________________________________
Your Mailing Address:________________________________________
__________________________________________________________
__________________________________________________________
Postal Code: _______________________________________________
Your Doctor’s Name: _________________________________________
Your Doctor’s Address: _______________________________________
__________________________________________________________
Postal Code: _______________________________________________
Tel No.: __________________________________________________
Please remember to inform us if you change address.

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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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