See Remark 8

• Antivirals
• Enzyme Inhibitors
• Neuraminidase Inhibitors
• ATC:J05AH01

• GANA
• GNA
• MODIFIED SIALIC ACID
• Relenza
• See Remark 8
• ZMR
• Zanamavir

RELENZA®(zanamivir for inhalation)

This leaflet contains important patient information about RELENZA (zanamivir for inhalation), and should be read completely before beginning treatment. It does not, however, take the place of discussions with your healthcare provider about your medical condition or your treatment. This summary does not list all benefits and risks of RELENZA. The medication described here can only be prescribed and dispensed by a licensed healthcare provider, who has information about your medical condition and more information about the drug, including how to take it, what to expect, and potential side effects. If you have any questions about RELENZA, talk with your healthcare provider.

What is RELENZA?

RELENZA (ruh-LENS-uh) is a medicine to treat influenza (flu, infection caused by influenza virus). It belongs to a group of medicines called neuraminidase inhibitors. These medications attack the influenza virus and prevent it from spreading inside your body. RELENZA treats the cause of influenza at its source, rather than simply masking the symptoms.

Important Safety Information About RELENZA

Some patients have had bronchospasm (wheezing) or serious breathing problems when they used RELENZA. Many but not all of these patients had previous asthma or chronic obstructive pulmonary disease. RELENZA has not been shown to shorten the duration of influenza in people with these diseases. Because of the risk of side effects and because it has not been shown to help them, RELENZA is not generally recommended for people with chronic respiratory disease such as asthma or chronic obstructive pulmonary disease. If you develop worsening respiratory symptoms such as wheezing or shortness of breath, stop using RELENZA and contact your healthcare provider right away. If you have chronic respiratory disease such as asthma and chronic obstructive pulmonary disease and your healthcare provider has prescribed RELENZA, you should have a fast-acting, inhaled bronchodilator available for your use. If you are scheduled to use an inhaled bronchodilator at the same time as RELENZA, use the inhaled bronchodilator before using RELENZA. Read the rest of this leaflet for more information about side effects and risks. Other kinds of infections can appear like influenza or occur along with influenza, and need different kinds of treatment. Contact your healthcare provider if you feel worse or develop new symptoms during or after treatment, or if your influenza symptoms do not start to get better.

Who should not take RELENZA?

RELENZA is not generally recommended for people who have chronic lung disease such as asthma or chronic obstructive pulmonary disease. RELENZA has not been shown to shorten the duration of influenza in people with these diseases, and some people have had serious side effects of bronchospasm and worsening lung function. You should not take RELENZA if you are allergic to zanamivir or any other ingredient of RELENZA. Also tell your healthcare provider if you have any type of chronic condition including lung or heart disease, if you are allergic to any other medicines or food products, or if you are pregnant.

Who should consider taking RELENZA?

Adult and pediatric patients at least 7 years of age who have influenza symptoms that appeared within the previous day or two. Typical symptoms of influenza include sudden onset of fever, cough, headache, fatigue, muscular weakness, and sore throat.

What can I expect if I take RELENZA?

In clinical studies, adults and children with influenza who took RELENZA recovered approximately one day faster on the average than influenza patients who did not take RELENZA. RELENZA does not treat flu-like illness that is not caused by influenza virus.

Can I take other medications with RELENZA?

RELENZA has been shown to have an acceptable safety profile when used as labeled, with minimal risk of drug interactions. Your healthcare provider may recommend taking other medications, including over-the-counter medications, to reduce fever or other symptoms while you are taking RELENZA. Before starting treatment, make sure that your healthcare provider knows if you are taking other medicines. If you are scheduled to use an inhaled bronchodilator at the same time as RELENZA, you should use the inhaled bronchodilator before using RELENZA.

How and when should I take RELENZA?

RELENZA is packaged in medicine disks called ROTADISKSÒand is inhaled by mouth using a delivery device called a DISKHALERÒ. Each ROTADISK contains 4 blisters. Each blister contains 5 mg of active drug and 20 mg of lactose powder (which contains milk proteins). You should receive a demonstration on how to use RELENZA in the DISKHALER from a healthcare provider. Before taking RELENZA, read the "Patient Instructions for Use." Make sure that you understand these instructions and talk to your healthcare provider if you have any questions. Children who use RELENZA should always be supervised by an adult who understands how to use RELENZA. Proper use of the DISKHALER to inhale the drug is necessary for safe and effective use of RELENZA. The usual dose is 2 inhalations of RELENZA (1 blister per inhalation) twice daily (in the morning and evening) for 5 days. It is important that you begin your treatment with RELENZA as soon as possible from the first appearance of your flu symptoms. Take 2 doses on the first day of treatment whenever possible if there are at least 2 hours between doses. Never share RELENZA with anyone, even if they have the same symptoms. If you feel worse or develop new symptoms during treatment with RELENZA, or if your flu symptoms do not start to get better, stop using the medicine and contact your healthcare provider.

What if I miss a dose?

If you forget to take your medicine at any time, take the missed dose as soon as you remember, except if it is near the next dose (within 2 hours). Then continue to take RELENZA at the usual times. You do not need to take a double dose. If you have missed several doses, inform your healthcare provider and follow the advice given to you.

What are important or common possible side effects of treatment with RELENZA?

Some patients have had breathing problems while taking RELENZA. This can be very serious and need treatment right away. Most of the patients who had this problem had asthma or chronic obstructive pulmonary disease, but some did not. If you have trouble breathing or have wheezing after your dose of RELENZA, stop taking RELENZA and get medical attention. In studies, the most common side effects during treatment with RELENZA in adults and adolescents have been headaches; diarrhea; nausea; vomiting; nasal irritation; bronchitis; cough; sinusitis; ear, nose, and throat infections; and dizziness. In children, the most common side effects were ear, nose, and throat infections; vomiting; and diarrhea. Other side effects that have been reported, but were not as common, include allergic reactions and rashes. This list of side effects is not complete. Your healthcare provider or pharmacist can discuss with you a more complete list of possible side effects with RELENZA. Talk to your healthcare provider promptly about any side effects you have. Please refer to the section entitled "Important Safety Information About RELENZA" for additional information.

Should I get a flu shot?

RELENZA has not been shown to keep people from getting influenza and is not a substitute for a flu shot. You should receive an annual flu shot according to guidelines on immunization practices that your healthcare provider can share with you.

What if I am pregnant or nursing?

If you are pregnant or planning to become pregnant while taking RELENZA, talk to your healthcare provider before taking this medication. RELENZA is normally not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

How and where should I store RELENZA?

RELENZA should be stored at room temperature below 77 F (25 C). RELENZA is not in a childproof container. Keep RELENZA out of the reach of children. Discard the DISKHALER after finishing your treatment.

PATIENTS INSTRUCTIONS FOR USE

RELENZA^Ò (zanamivir for inhalation)

IMPORTANT: Read Step-by-Step Instructions before using the DISKHALERÒ.

Be sure to take the dose your healthcare provider has prescribed.

BEFORE YOU START:

Please read the entire Patient Information for important information about the effects of RELENZA including the section "Important Safety Information about RELENZA" for information about the risk of breathing difficulties.

If RELENZA is prescribed for a child, dosing should be supervised by an adult who understands how to use RELENZA and has been instructed in its use by a healthcare provider.

Step-by-step instructions for using the DISKHALERÒ Step A: Load the medicine into the DISKHALER

1. Start by pulling off the blue cover.

2. Always check inside the mouthpiece to make sure it is clear before each use. If foreign objects are in the mouthpiece, they could be inhaled and cause serious harm.

3. Pull the white mouthpiece by the edges to extend the white tray all the way.

4. Once the white tray is extended all the way, find the raised ridges on each side of it. Press in these ridges, both sides at the same time, and pull the whole white tray out of the DISKHALER body.

5. Place one silver medicine disk onto the dark brown wheel, flat side up. The four silver blisters on the underside of the medicine disk will drop neatly into the four holes in the wheel.

6. Push in the white tray as far as it will go. Now the DISKHALER is loaded with medicine.

Step B: Puncture the blister

Be sure to keep the DISKHALER level.

The DISKHALER punctures one blister of medicine at a time so you can inhale the right amount. It does not matter which blister you start with. Check to make sure that the silver foil is unbroken.

1. Be sure to keep the DISKHALER level so the medicine does not spill out.

2. Locate the half-circle flap with the name "RELENZA" on top of the DISKHALER.

3. Lift this flap from the outer edge until it cannot go any farther. Flap must be straight up for the plastic needle to puncture both the top and bottom of the silver medicine disk inside.

4. Keeping the DISKHALER level, click the flap down into place.

Step C: Inhale

1. Before putting the white mouthpiece into your mouth, breathe all the way out (exhale).

Then put the white mouthpiece into your mouth. Be sure to keep the DISKHALER level so the medicine does not spill out.

2. Close your lips firmly around the mouthpiece. Be sure not to cover the small holes on either side of it.

3. Breathe in through your mouth steadily and as deeply as you can. Your breath pulls the medicine into your airways and lungs.

4. Hold your breath for a few seconds to help RELENZA stay in your lungs where it can work.

To take another inhalation, move to the next blister by following Step D below.

Once you've inhaled the number of blisters prescribed by your healthcare provider, replace the cover until your next dose.

Step D: Move the medicine disk to the next blister

1. Pull the mouthpiece to extend the white tray, without removing it.

2. Then push it back until it clicks. This pull-push motion rotates the medicine disk to the next blister.

3. To take your next inhalation, repeat Steps B and C.

If all four blisters in the medicine disk have been used, you are ready to start a new medicine disk. Check to make sure that the silver foil is unbroken each time you are ready to puncture the next blister.