EPIPEN AUTO-INJECTOR 0.3MG

Active substance: ADRENALINE

View full screen / Print PDF » Download PDF ⇩

Transcript
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.
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.

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.

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.
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.
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.

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'.
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

5. How To Store EpiPen®
Keep out of the reach and sight of children.
Do not use EpiPen® after the expiry date which is
stated on the label.
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 discoloured 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 October 2011.
For information in large print, tape, CD or Braille,
telephone 0800 1985000

56UK2065103-00

7

6

8

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.

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.

426

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

2

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.
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.

3. How to use EpiPen®

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.

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.

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.

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.

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® given below
must be carefully followed.

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.

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

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.
3

Dosage
The dose will be decided by your doctor, who will
adjust it individually for you. The usual adult dose
for allegic 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.
4

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.
5

44927A

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:

Expiry Date:
(see label)

Your Doctor’s Name:

Your Doctor’s Address:

Postal Code:

Tel No.:

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.

Blue safety cap

PATIENT INFORMATION LEAFLET
EpiPen® Auto-Injector

Adrenaline

0.3 mg

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 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.
1

Expand view ⇕

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.

Hide
(web1)