Relenza

Relenza is used for:

Treating uncomplicated influenza in patients 7 years old and older who have had symptoms for no more than 2 days. It may also be used to prevent influenza in patients 5 years old and older.

Relenza is an antiviral agent. It works by interfering with viral enzymes that allow respiratory viruses to grow and spread.

Do NOT use Relenza if:

• you are allergic to any ingredient in Relenza , to lactose, or to milk protein

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

Before using Relenza :

Some medical conditions may interact with Relenza . 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 heart problems or a lung disease, including asthma, chronic obstructive pulmonary disease (COPD), or emphysema, or if you have a lung infection

Some MEDICINES MAY INTERACT with Relenza . However, no specific interactions with Relenza are known at this time.

Ask your health care provider if Relenza 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 Relenza :

Use Relenza as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Relenza . Talk to your pharmacist if you have questions about this information.
• Follow instructions given to you by your doctor, pharmacist, or health care provider for using the medicine delivery device.
• Do not puncture the medicine blister until you are ready to take a dose.
• Continue Relenza for the full course of treatment even if you feel better in a few days. Do not miss any doses.
• If you have asthma or COPD and have a dose of the bronchodilator inhaler scheduled at the same time as Relenza , use the bronchodilator before using Relenza . Be sure to always carry a fast-acting bronchodilator inhaler with you to use in case of bronchospasm while using Relenza .
• If you miss a dose of Relenza , use it as soon as possible. If it is almost time for your next dose (within 2 hours), skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. If more than 1 dose is missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Relenza .

Important safety information:

• Relenza may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Relenza with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Relenza will not prevent you from spreading influenza to others.
• Relenza should not be used in place of the influenza vaccine recommended by the Centers for Disease Control and Prevention (CDC).
• Relenza may interfere with the nasal influenza (flu) vaccine. Do not use Relenza within 2 weeks after receiving the nasal flu vaccine, unless your doctor tells you to. Do not receive the nasal flu vaccine for at least 48 hours after you use Relenza , unless your doctor tells you to. Talk with your doctor if you have recently received or will be receiving the nasal flu vaccine.
• Contact your doctor at once if you have lung or breathing problems (eg, asthma, COPD) and your symptoms become worse, or if you have problems breathing, such as wheezing or shortness of breath, or other signs of bronchospasm.
• Caution is advised when using Relenza in CHILDREN; they may be more sensitive to its effects, especially seizures, confusion, and abnormal behavior.
• Relenza should be used with extreme caution in CHILDREN younger than 5 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Relenza while you are pregnant. It is not known if Relenza is found in breast milk. If you are or will be breast-feeding while you use Relenza , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Relenza :

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:

Cough; diarrhea; dizziness; headache; nausea; sinus inflammation; stuffy nose; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal behavior; hallucinations; irregular heartbeat; mood or mental changes; seizures; shortness of breath; trouble swallowing; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately.

Store Relenza at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Do not puncture the blister until you are ready to take a dose using the Diskhaler. Keep Relenza out of the reach of children and away from pets.

General information:

• If you have any questions about Relenza , please talk with your doctor, pharmacist, or other health care provider.
• Relenza 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 Relenza . 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.

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