ANAPEN JUNIOR 150 MICROGRAMS IN 0.3ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
Give your used Anapen to the hospital or pharmacist for proper disposal.
If you use more Anapen Junior than you should
• If you inject too much adrenaline or inject the medicine accidently into a blood
vessel or finger, you should seek immediate medical attention at the nearest
• If you have further questions on the use of this product, ask your doctor or
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Anapen can have side- effects, although not everybody gets
• Anapen Junior contains sodium metabisulphite (E223) which can cause allergic
type reactions and difficulty in breathing especially in those with a history of
asthma. You should seek immediate medical attention if you experience these
• Common side-effects of adrenaline include a sensation of heart pounding
(palpitations), rapid or uneven heart beat, sweating, nausea, vomiting,
difficulty in breathing, dizziness, weakness, pale skin (pallor), trembling,
headache, apprehension, nervousness, anxiety and coldness of extremities.
• Other less frequent side-effects include hallucinations, fainting, dilated pupils,
difficulty in urinating, muscle shakes, raised blood pressure and changes to the
blood such as high sugar levels, low potassium levels and high acid content.
• Occasionally, at high doses, or in susceptible patients, a sudden increase in
blood pressure which may cause bleeding into the brain, irregular heart beat
and heart attack and reduced blood flow to the skin, mucous tissues and
kidneys may occur.
If any side-effects get serious or you notice any side-effects not mentioned in this
leaflet, please inform your doctor, healthcare professional or pharmacist.
5. HOW TO STORE ANAPEN JUNIOR
Keep out of reach and sight of children
• Do not use the Anapen Junior Auto-Injector after the expiry date shown on the
• Do not store above 25°C.
• To protect from light store in the original packaging.
• Your used or expired Anapen should be given to the hospital or pharmacist for
6. FURTHER INFORMATION
What Anapen Junior contains
• The active substance is adrenaline (epinephrine) 150 micrograms in 0.3ml.
• The medicine also contains: sodium metabisulphite (E223) sodium chloride,
hydrochloric acid, water for injections.
What Anapen Junior looks like and the contents of the pack
Anapen consists of a pre-filled syringe of adrenaline solution for injection
contained in an Auto-Injection device (Auto-Injector). It is produced in two
dosage strengths, Anapen 300 micrograms in 0.3ml solution for injection and
Anapen Junior 150 micrograms in 0.3ml solution for injection.
Anapen is supplied in units of 1 or 2. Not all packs are available in some markets.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder: Lincoln Medical Limited,
Unit 8 Wilton Business Centre, Wilton, Salisbury, SP2 0AH, UK.
Distributor: Allergy Therapeutics(UK) Ltd., Dominion Way, Worthing,
West Sussex, BN14 8SA, UK.
Manufacturer: Owen Mumford Limited, Brook Hill, Woodstock, Oxon, OX20 1TU, UK.
This medicinal product is authorised in Member States
of the EEA under the following names:
• United Kingdom, Ireland, Greece, Cyprus, Austria:
Anapen Junior 150 micrograms in 0.3ml Solution for Injection.
• Bulgaria, Poland, Hungary, Czech Republic, Romania:
Anapen Junior 150 micrograms/0.3ml Solution for Injection.
• France, Luxembourg, Portugal:
Anapen Junior 0.15mg/0.3ml Solution for Injection.
• Germany: Anapen Junior 150 mikrogramm Solution for Injection.
• Sweden: Anapen Junior 0.15mg/dos Solution for Injection.
• Netherlands: Anapen Junior 0.15mg/dosis Solution for Injection.
This leaflet was last approved: 10/2010
Anapen Junior is a registered trade mark
PACKAGE LEAFLET: INFORMATION FOR
in 0.3 ml solution for injection in a pre-filled syringe
Adrenaline (Epinephrine) Auto-Injector
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 further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not
pass it on to others. It may harm them, even if their symptoms are the same
• If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.
In this leaflet:
1 - What Anapen Junior
is and what it is used for?
2 - Before you use Anapen Junior
3 - How to use Anapen Junior
4 - Possible side effects
5 - How to store Anapen Junior
6 - Further information
1 WHAT ANAPEN IS AND WHAT IT IS USED FOR?
• Anapen Junior consists of a pre-filled syringe of adrenaline contained in an
automatic injection device (Auto-Injector). This injects a single dose of
adrenaline into muscle.
• This medicine is for emergency only and you should seek immediate medical
attention after using your Auto-Injector.
• Adrenaline is a natural hormone released in response to stress. In acute allergic
reactions it improves blood pressure, heart function and breathing, and reduces
swelling. Adrenaline is also known as epinephrine.
• Anapen Junior is used for the emergency treatment of serious allergic reactions
or anaphylaxis caused by peanuts or other foods, drugs, insect bites or stings
and other allergens as well as exercise or an unknown cause.
2. BEFORE YOU USE ANAPEN JUNIOR
Do not use Anapen Junior
• If you are allergic (hypersensitive) to adrenaline or any of its other ingredients
(see section below for information on sulphites).
Take special care with Anapen Junior
• Your doctor should have carefully instructed you when to use and the correct
way to use your Anapen Junior Auto-Injector.
• You should tell your doctor if you are suffering from heart disease, including
angina, hyperthyroidism, high blood pressure, lowered potassium levels and
increased calcium in the blood, disorders of the blood circulation,
phaeochromocytoma (a type of tumour in the adrenal gland), raised pressure
inside the eye (glaucoma), kidney or prostate disease diabetes or any other
• Repeated local injection can result in skin damage at sites of injection.
Accidental injection into a blood vessel may result in a sudden rise in blood
pressure. Accidental injection into the hand or foot may result in loss of blood
flow to the affected part. You should immediately seek medical advice at the
Using other medicines
You should also tell your doctor if you are presently receiving medicines
• Medicines for heart disease, such as digitalis (digoxin), beta-blockers, quinidine.
• Medicines for depression, such as tricylic antidepressants, mono amine oxidase
inhibitors (MAOIs), serotonin and noradrenaline reuptake inhibitors (SNRIs).
• Medicines for diabetes; your doctor may change the dosage of your medication
after using Anapen.
• Medicines for Parkinson’s disease.
• Medicines for thyroid disease.
• Other medicines: antihistamines such as diphenhydramine or chlorpheniramine,
theophylline, ipratropium and oxitropium (used to treat airways disease
including asthma), oxytocin (used in labour in pregnancy), inhaled anaesthetics,
alpha adrenergic blockers (used to treat high blood pressure),
sympathomimetics (used to treat asthma, other airways disease and nasal
Inform your doctor, health professional or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained without a
Using Anapen Junior with food and drink
Alcohol may adversely affect this medicine by increasing the effects of this
Pregnancy and breast-feeding
• It is not clear whether taking adrenaline during pregnancy is of risk to the
unborn child; This should not deter you if you are pregnant from using Anapen
Junior in an emergency, as your life might be in danger. You should discuss this
with your doctor before such an emergency occurs.
• Adrenaline would not be expected to have any effect on the breast-feeding
infant. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You should not drive or use machinery after injecting this medicine, since you
may still be experiencing the effects of an anaphylactic shock.
Important information about some of the ingredients of Anapen Junior:
Anapen Junior contains sodium metabisulphite (E223) which can cause allergic
type reactions and difficulty in breathing especially in those with a history of
asthma. You should tell your doctor if you know you are allergic to sodium
metabisulphite. This medicinal product contains less than 1mmol sodium (23 mg)
per dose. i.e. essentially sodium free.
3. HOW TO USE ANAPEN JUNIOR
• Always use the medicine exactly as your doctor has instructed you.
• Check with your doctor or pharmacist if you are unsure.
• Only inject into the thigh muscle.
• For single use only, please ensure you discard safely immediately after use.
The reaction usually starts within minutes of contact with the allergen and the
person may experience:
• Itching of the skin, a raised urticarial rash (nettle rash), flushing and swelling
of eyes, lips or tongue.
• Difficulty in breathing due to swelling of the throat. Wheezing, shortness of
breath and coughing may result from tightening of the muscles in the lungs.
• Other symptoms of anaphylaxis including headache, vomiting and diarrhoea.
• Collapse and loss of consciousness due to a sudden lowering of blood pressure.
When you experience these signs and symptoms use the Anapen Junior AutoInjector immediately. You must only inject this medicine into the muscle on the
outer part of your thigh, not the buttock.
For use in children
• The appropriate dose is 150 micrograms or 300 micrograms.
• This depends on the body weight of the child and the discretion of the doctor.
• An Auto-Injector that delivers 300 micrograms of adrenaline is also available.
A dosage below 150 micrograms cannot be administered with sufficient
accuracy in children weighing less than 15kg and use is therefore not
recommended unless in a life-threatening situation and under medical advice.
You should notify your doctor or attend the nearest hospital as soon as possible
after use of Anapen Junior. Make sure you explain that you have received an
injection of adrenaline into your thigh muscle. Show the doctor the box and
Instructions for use
A. Parts of the Anapen Auto-Injector
Before you use your Anapen Auto-Injector, you need to know about the parts of
the Auto-Injector. These are shown in the picture:
Needle end of
Rotating cover over
Red firing button
• Rotating cover over solution window: You rotate the cover over the solution
windows to line up the lenses with the solution windows on the Auto-Injector
• Solution window: You look through the lens into this window before the
injection to check that the solution is clear and ready to use.
• Injection indicator: Before the injection, you can see a white plastic plunger
through the window. This means that the Anapen Auto-Injector has not been
fired by mistake or tampered with. After the injection, the injection indicator
turns red. This indicates that the Anapen Auto-Injector has been fired correctly.
• Black needle shield (reversible): This protects the needle when you are not
using the Anapen Auto-Injector. You pull the needle shield off before the
injection. After the injection, turn the black needle shield around and put it
back onto the same end of Anapen Auto-Injector, to cover the needle.
• Grey safety cap: This covers the red firing button. It stops the button from being
pushed by mistake.
Do not remove the black needle shield or the grey safety cap until you need to
use your Anapen Auto-Injector.
B. Checking your Anapen Auto-Injector
Before you use your Anapen Auto-Injector, you must check it as follows:
1. Rotate the cover over the solution window fully anticlockwise as
shown by the arrows to line up the lenses with the solution
windows on the Auto-Injector body.
2. Look through the lens into the solution window. Check that the
solution is clear and colourless. If it is cloudy, coloured or contains
particles, discard the Anapen Auto-Injector.
3. Make sure that the injection indicator is not red.
If it is red, this means that the Anapen Auto-Injector has already
been fired and you must discard it.
4. Rotate the cover over the solution window fully back clockwise as
shown by the arrows to ensure both solution windows are covered. Put
the Anapen Auto-Injector back in the carton until you need to use it.
C. Using the Anapen Auto-Injector
If the black needle shield has been removed, do not put your thumb, fingers or
hand over the open end (needle end) of the Anapen Auto-Injector.
To use the Anapen Auto-Injector, follow the steps below:
1. Remove the black needle shield by pulling hard in the direction of
the arrow. This also removes a grey protective needle sheath.
2. Remove the grey safety cap from the red firing button by pulling
as indicated by the arrow.
3. Hold the open end (needle end) of Anapen against the outer part
of your thigh. If necessary, you can use Anapen through light
clothing, such as denim, cotton or polyester.
4. Press the red firing button so that it clicks. Keep holding the Anapen
Auto-Injector against your thigh for 10 seconds. Slowly remove
Anapen from your thigh. Then gently massage the injection area.
5. The injection indicator will have turned red. This shows that the
injection is complete. If the injection indicator is not red, you must
repeat the injection with a new Anapen.
6. After the injection, the needle sticks out. To cover it, click the
wide end of the black needle shield back on the open end (needle
end) of Anapen Auto-Injector (as indicated by the arrow).
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.