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Notice anapen_uk_150 mgv7:mise en page

Notice anapen_UK_150 mgV7:Mise en page 1 16/06/09 15:43 Page 1 asthma. You should seek immediate medical attention if you experience theseside effects.
• Common side effects of adrenaline include a sensation of heart pounding PACKAGE LEAFLET: INFORMATION FOR THE USER
(palpitations), rapid or uneven heart beat, sweating, nausea, vomiting,difficulty in breathing, dizziness, weakness, pale skin (pallor), trembling, Anapen® Junior 150 micrograms
headache, apprehension, nervousness, anxiety and coldness of extremities. • Other less frequent side effects include hallucinations, fainting, dilated pupils, in 0.3 ml solution for injection
difficulty in urinating, muscle shakes, raised blood pressure and changes to theblood 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 heartbeatand heart attack and reduced blood flow to the skin, mucous tissues and Read all of this leaflet carefully before you start using
kidneys may occur. If any side effects get serious or you notice any side effects not mentioned in thisleaflet, please inform your doctor, healthcare professional or pharmacist.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
5 How to store Anapen Junior
• This medicine has been prescribed for you personally and you should not Keep out of reach and sight of children
pass it on to others. It may harm them, even if their symptoms are the same • Do not use the Anapen Junior Auto-Injector after the expiry date shown on
• If any of the side effects get serious, or if you notice any side effects not • Do not store above 25°C. listed in this leaflet, please tell your doctor.
• To protect from light store in the original packaging.
Medicines should not be disposed of via wastewater or household waste.
In this leaflet:
Ask your pharmacist how to dispose of medicines no longer required. These 1 - What Anapen Junior is and what it
measures will help to protect the environment.
Never give your Anapen Junior Auto-Injector to another person even if his or
her symptoms are similar to yours. This medicine is for your personal use only.
2 - Before you use Anapen Junior
6 Further Information
3 - How to use Anapen Junior
4 - Possible side effects
What Anapen Junior contains
• The active substance is adrenaline (epinephrine) 150 micrograms in 0.3 ml.
5 - How to store Anapen Junior
• The medicine also contains: Sodium metabisulphite (E223), Sodium chloride, 6 - Further information Hydrochloric acid, Water for injections.
What Anapen Junior looks like and the contents of the pack
1 What Anapen Junior is and what it is used for?
Anapen Junior consists of a pre-filled syringe of adrenaline solution for injection
Anapen Junior consists of a pre-filled syringe of adrenaline contained in an
contained in an auto-injection device (Auto-Injector). Anapen is produced in two
automatic injection device (Auto-Injector). This injects a single dose of dosage strengths, Anapen 300 micrograms in 0.3 ml solution for injection and
adrenaline into muscle. Anapen Junior 150 micrograms in 0.3 ml solution for injection.
Adrenaline is a natural hormone released in response to stress. In acute allergic
Anapen Junior is supplied in units of 1 or 2. Not all packs are available in some
reactions it improves blood pressure, heart function and breathing, and reduces Marketing Authorisation Holder and Manufacturer:
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 Marketing Authorisation Holder and other allergens as well as exercise or an unknown cause.
Lincoln Medical Limited, Unit 8 Wilton Business Centre, Wilton Salisbury, SP2 0AH, UK 2 Before you use Anapen Junior
Manufacturer: Owen Mumford Limited - Brook Lane Woodstock Oxon 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).
This medicinal product is authorised in Member States of the EEA under thefollowing names: Take special care with Anapen Junior
United Kingdom, Ireland, Greece, Cyprus, Austria: • Your doctor should have carefully instructed you when to use and the correct Anapen Junior 150 micrograms in 0,3 ml Solution for Injection way to use your Anapen Junior Auto-Injector.
Poland, Hungary, Czech Republic, Bulgaria, Romania: • This medicine is for emergency only and you should seek immediate medical Anapen Junior 150 micrograms/ 0,3 ml Solution for Injection attention after using your Auto-Injector.
France, Luxembourg, Portugal: Anapen 0,15 mg/0,3ml Solution for injection • You should tell your doctor if you are suffering from heart disease, including Germany: Anapen Junior 150 mikrogramm Solution for injection angina, hyperthyroidism, high blood pressure, lowered potassium levels and Sweden: Anapen Junior 0,15 mg/dos Solution for injection increased calcium in the blood, disorders of the blood circulation, The Netherlands: Anapen 0.15 mg/dosis Solution for Injection phaeochromocytoma (a type of tumour in the adrenal gland), raised pressure This leaflet was last approved: 11/12/07. Anapen is a registered trade mark inside the eye (glaucoma), kidney or prostate disease, diabetes or any othermedical condition.
Notice anapen_UK_150 mgV7:Mise en page 1 16/06/09 15:43 Page 3 • Repeated local injection can result in skin damage at sites of injection.
• Difficulty in breathing following swelling of the throat.Wheezing, shortness of Accidental injection into a blood vessel may result in a sudden rise in blood breath and coughing may result from tightening of the muscles in the lungs. pressure. Accidental injection into the hand or foot may result in loss of blood • Other symptoms of anaphylaxis including headache, vomiting and diarrhoea.
flow to the affected part.You should immediately seek medical advice at the • Collapse and loss of consciousness due to a sudden lowering of blood pressure.
nearest hospital.
When you experience these signs and symptoms use the Anapen Junior Auto-
Using other medicines
Injector immediately. You must only inject this medicine into the muscle on the You should also tell your doctor if you are presently receiving medicines outer part of your thigh, not the buttock.
For use in children
• Medicines for heart disease, such as digitalis (digoxin), beta-blockers, quinidine, • The appropriate dose is 150 micrograms or 300 micrograms .
• Medicines for depression, such as tricylic antidepressants, mono amine oxidase inhibitors (MAOI's), serotonin and noradrenaline reuptake inhibitors(SNRIs), • This depends on the body weight of the child and the discretion of the doctor. • Medicines for diabetes, your doctor may change the dosage of your medication • An Auto-Injector that delivers 300 micrograms of adrenaline is also available. after using Anapen Junior.
A dosage below 150 micrograms cannot be administered in sufficient accuracyin children weighing less than 15 kg and use is therefore not recommended • Medicines for Parkinson's disease, unless in a life-threatening situation and under medical advice.
• Medicines for thyroid disease, You should notify your doctor or attend the nearest hospital as soon as possible • Other Medicines: Antihistamines such as diphenhydramine or chlorpheniramine, after use of Anapen Junior. Make sure you explain that you have received an
theophylline, ipratropium and oxitropium (used to treat airways disease injection into your thigh muscle of adrenaline. Show the doctor the box and these 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 nasalcongestion).
Important Instructions for use (See diagrams 1- 4 below)
Inform your doctor, health professional or pharmacist if you are taking or have • DO NOT REMOVE the black safety cap or the black needle cap until you need recently taken any other medicines, including medicines obtained without a to use your Anapen Junior.
Black safety cap
Using Anapen Junior with food and drink
Black needle cap
Red firing button
Alcohol may adversely affect this medicine by increasing the effects of thismedicine. Pregnancy & 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 breastfeeding Remove black
Remove the black
Hold Anapen against Hold Anapen in
infant. Ask your doctor or pharmacist for advice before taking any medicine.
needle cap.
safety cap from the outer thigh, and
position for
This cap is attached red firing button
press the firing
10 seconds (This
Driving and using machines:
to a grey protective allows the full dose You should not drive or use machinery after injecting this medicine, since you needle sheath and of adrenaline to be made through light injected). may still be experiencing the effects of an anaphylactic shock.
reasonable force to clothing if necessary. Gently massage the
Important information about some of the ingredients of Anapen Junior:
Anapen Junior contains sodium metabisulphite (E223)
which can cause allergic
• After use replace the black needle cap and return the medicine to your type reactions and difficulty in breathing especially in those with a history of pharmacy or doctor for safe disposal.
asthma. You should tell your doctor if you know you are allergic to sodiummetabisulphite.
If you use more Anapen Junior than you should
• If you inject too much adrenaline or inject the medicine accidently into a blood
3 How to use Anapen Junior
vessel or finger you should seek immediate medical attention at the nearest • Always use this medicine exactly as your doctor has instructed you. • Check with your doctor or pharmacist if you are unsure. • If you have further questions on the use of this product, ask your doctor or • Only inject into the thigh muscle.
• For single use only, please ensure you discard safely immediately after use.
4 Possible side effects
The reaction usually starts within minutes of contact with the allergen and the Like all medicines, Anapen Junior can have side effects, although not everybody
person may experience: • Itching of the skin, a raised urticarial rash (nettle rash), flushing and swelling • Anapen Junior contains sodium metabisulphite (E223) which can cause allergic
of eyes, lips or tongue.
type reactions and difficulty in breathing especially in those with a history of


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