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ANAPEN 500 MICROGRAMS IN 0.3ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

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Seek medical advice. Take this leaflet and your Anapen with you.
Give your used Anapen to the hospital or pharmacist for proper disposal.
If you use more Anapen 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
hospital.
• If you have further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Anapen can have side- effects, although not everybody gets
them.
• Anapen 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 sideeffects.
• 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
Keep out of reach and sight of children
• Do not use the Anapen Auto-Injector after the expiry date (exp. date) shown
on the carton.
• Do not store above 25°C.
• To protect from light store in the original package.
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.
Never give your Anapen Auto-Injector to another person even if his or her
symptoms are similar to yours. This medicine is for your personal use only.
6. FURTHER INFORMATION
What Anapen contains
• The active substance is adrenaline (epinephrine) 500 micrograms in 0.3ml.
• The medicine also contains: sodium metabisulphite (E223) sodium chloride,
hydrochloric acid, water for injections.
What Anapen looks like and the contents of the pack
Anapen 500 micrograms in 0.3ml solution for injection consists of a pre-filled
syringe of adrenaline solution for injection contained in an auto injection device
(Auto-Injector).It is produced in a dosage strength of 500 micrograms in 0.3ml
solution for injection.
Anapen is supplied in units of 1.
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, Austria:
Anapen 500 micrograms in 0,3 ml Solution for Injection
France: Anapen 0,50mg/0,3ml Solution for injection
Germany: Anapen 500 mikrogramm solution for injection
Sweden: Anapen 0,50 mg/dos solution for injection
The Netherlands: Anapen 0,5mg/dosis Solution for Injection
This leaflet was last approved: 01/06/09.
Anapen is a registered trade mark

PACKAGE LEAFLET: INFORMATION FOR
THE USER

Anapen®
500 micrograms
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
as yours.
• 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
is and what it is used for?
2 - Before you use Anapen
3 - How to use Anapen
4 - Possible side effects
5 - How to store Anapen
6 - Further information
1 WHAT ANAPEN IS AND WHAT IT IS USED FOR?
• Anapen 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 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
Do not use Anapen
• 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
• Your doctor should have carefully instructed you when to use and the correct
way to use your Anapen 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
medical condition.
• 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
nearest hospital.
Using other medicines
You should also tell your doctor if you are presently receiving medicines
particularly;
• 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
congestion).
Inform your doctor, health professional or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained without a
prescription.
Using Anapen with food and drink
Alcohol may adversely affect this medicine by increasing the effects of this
medicine.
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
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 :
Anapen 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
• 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 Auto-Injector
immediately. You must only inject this medicine into the muscle on the outer part
of your thigh, not the buttock.
For use in adults
• The usual dose is 300 micrograms.
• For larger adults the 300 micrograms dose may not be sufficient and these
patients may need Anapen 500 micrograms in the autoinjector.
• In circumstances where a single dose of adrenaline does not completely reverse
the effect of an allergic reaction, a repeat injection may be given after 10 to
15 minutes.
For use in children
Anapen 500 micrograms is not recommended for use in children.
You should notify your doctor or attend the nearest hospital as soon as possible
after use of Anapen. Make sure you explain that you have received an injection
of adrenaline into your thigh muscle. Show the doctor the box and these
instructions.

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:
Black needle
shield (reversible)

Needle end of
Auto-Injector

Rotating cover over
solution window

Lens

Injection
Indicator

Tamper
proof lock

Grey
safety cap

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
body.
• 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

2

3

4

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

2

3
4

5

6

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).

Expand Transcript

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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