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EpiPen Auto-Injector is used for:

Treating severe allergic reactions (eg, difficulty breathing; rash; hives; tightness in the chest; swelling of the mouth, lips, or tongue) caused by insect stings or bites, foods, drugs, or other causes. It may also be used for other conditions as determined by your doctor.

EpiPen Auto-Injector is a sympathomimetic. It works on different receptors in the body to relax the smooth muscle of the lungs, which improves breathing. It also blocks histamine, which decreases rash, hives, and swelling.

Do NOT use EpiPen Auto-Injector if:

• you are allergic to any ingredient in EpiPen Auto-Injector

Contact your doctor or health care provider right away if any of these apply to you.

Before using EpiPen Auto-Injector:

Some medical conditions may interact with EpiPen Auto-Injector. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have angle-closure glaucoma, heart disease, chest pain, high blood pressure, diabetes, thyroid problems, mental or mood disorders, depression, asthma, or an irregular heartbeat

Some MEDICINES MAY INTERACT with EpiPen Auto-Injector. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), droxidopa, or phenothiazines (eg, chlorpromazine) because the risk of high or low blood pressure and fast or slow heartbeat may be increased
• Bromocriptine, furazolidone, or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects, such as headache, high temperature, and high blood pressure, may be increased
• Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, or medicines for irregular heartbeat (eg, quinidine) because they may increase the risk of EpiPen Auto-Injector's side effects
• Guanethidine because its effectiveness may be decreased by EpiPen Auto-Injector

This may not be a complete list of all interactions that may occur. Ask your health care provider if EpiPen Auto-Injector may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use EpiPen Auto-Injector:

Use EpiPen Auto-Injector as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with EpiPen Auto-Injector. Talk to your pharmacist if you have questions about this information.
• EpiPen Auto-Injector is an injection. If you will be using EpiPen Auto-Injector at home, a health care provider will teach you how to use it. Be sure you understand how to use EpiPen Auto-Injector. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Check EpiPen Auto-Injector regularly. Replace the injector unit if it contains particles, is discolored, or is cracked or damaged in any way.
• Inject EpiPen Auto-Injector only into the outer thigh. Do not inject into the buttocks or into a vein.
• Immediately after use, go to the nearest hospital emergency room. You may need further medical attention. Tell the doctor or health care provider that you have received an injection of epinephrine. Show the thigh where the injection was given to the doctor. Give your used auto-injector to the doctor for inspection and proper disposal.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• EpiPen Auto-Injector is usually given in an emergency situation. If you are unable to use EpiPen Auto-Injector, seek medical attention immediately.
• If you miss a dose of EpiPen Auto-Injector, contact your doctor right away.

Ask your health care provider any questions you may have about how to use EpiPen Auto-Injector.

Important safety information:

• Never put thumb, fingers, or hand over the black tip of the auto-injector. Do NOT remove the gray activation cap until ready to use.
• Only inject EpiPen Auto-Injector into the outer thigh. Never inject EpiPen Auto-Injector into hands, fingers, feet, or toes. Doing so may cause a loss of blood flow and result in tissue damage to these areas. If you accidentally inject EpiPen Auto-Injector into any of these areas, seek immediate emergency medical attention.
• There is a trainer available to help you practice using this device. It may be helpful to train others how to give EpiPen Auto-Injector in case you are unable to give it yourself during a reaction.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using EpiPen Auto-Injector while you are pregnant. It is not known if EpiPen Auto-Injector is found in breast milk. If you are or will be breast-feeding while you use EpiPen Auto-Injector, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of EpiPen Auto-Injector:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; difficulty sleeping; dizziness; fearfulness; headache; nausea; nervousness; paleness; sweating; tremors; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast heartbeat; irregular heartbeat; wheezing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include bleeding in the brain; fast or irregular heartbeat; fluid in the lungs; high blood pressure.

Store EpiPen Auto-Injector at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep EpiPen Auto-Injector out of the reach of children and away from pets.

General information:

• If you have any questions about EpiPen Auto-Injector, please talk with your doctor, pharmacist, or other health care provider.
• EpiPen Auto-Injector is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about EpiPen Auto-Injector. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.