EPIPEN AUTO-INJECTOR 0.3MG

Blue safety cap

EpiPen
Orange tip

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.

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.

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.

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PATIENT INFORMATION LEAFLET EpiPen Auto-Injector

Please remember to inform us if you change address. Tel No.:

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.

Postal Code: Postal Code:

Your Mailing Address: Your Doctors Address:

Your Full Name: Your Doctors Name:

Lot No.: (see label) Expiry Date: (see label)

Please print clearly in capital letters.

EpiPen Expiry Date Alert Form

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 Service

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.

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.

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, Bishops 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

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.
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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
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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 25C. 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
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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. 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. 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. 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 babys 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.
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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.

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 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. 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 30 kg. For persons weighing less than 30 kg (4 stone 9 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 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.
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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. 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. The instructions for use of the EpiPen given below must be carefully followed. EpiPen should only be injected into the outer thigh. It should not be injected into the buttock (your bottom). 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.
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