ZANAMIVIR (Inhalation?Systemic)

Some commonly used brand names are:

In the U.S.?

• Relenza

In Canada?

• Relenza

Category

• Antiviral

Description

Zanamivir (zan-AM-e-veer)isused in the treatment of the infection caused by the flu virus (influenzaA and influenza B). Zanamivir may reduce flu symptoms (weakness, headache,fever, cough, and sore throat) by 1 to 1.5 days. Zanamivir does not preventinfluenza infection.

This medicine must be started within 2 days of having flu symptoms (weakness,headache, fever, cough, and sore throat). Zanamivir will not keep you fromspreading the flu virus to other people. Zanamivir may not work for everybody.Zanamivir may not be for you if you are severely sick or have a breathingproblem (like asthma or chronic obstructive pulmonary disease). If you receivethe flu vaccine every year, continue to do so.

Before Using This Medicine

Allergies?Tell your doctor if you have ever had any unusual or allergicreaction to zanamivir.

Pregnancy?Zanamivir has not been studied in pregnant women. However, zanamivirhas not been shown to cause birth defects or other problems in animal studies.

Breast-feeding?It is not known whether zanamivir passes into breast milk.Although most medicines pass into breast milk in small amounts, many of themmay be used safely while breast-feeding. Mothers who are using this medicineand who wish to breast-feed should discuss this with their doctor.

Children?This medicine is not recommended for use in children youngerthan 7 years of age. This medicine has been tested in children 12 years andolder and has not been shown to cause different side effects or problems inthese children than it does in adults.

Note:

This medicine is available in Canada. It is not recommended in childrenyounger than 12 years of age.

Older adults?This medicine has been tested in older adults andhas not been shown to cause different side effects or problems in older adultsthan it does in younger adults.

Other medicines?Although certain medicines should not be used togetherat all, in other cases two different medicines may be used together even ifan interaction might occur. In these cases, your doctor may want to changethe dose, or other precautions may be necessary. Tell your health care professionalif you are taking any other prescription or nonprescription (over the counter[OTC]) medicine before using zanamivir.

Other medical problems?The presence of other medical problemsmay affect the use of zanamivir. Make sure to tell your doctor if you haveany other medical problems, especially:

• Lung Disease?Patients with lung disease (chronic obstructivepulmonary disease or asthma) may experience trouble breathing with the useof zanamivir. Zanamivir may not work in patients with chronic lung disease.

• Heart Disease?Zanamivir may not work in patients with heartdisease.

Proper Use of This Medicine

Talk to your doctorabout the possibility of getting a flu shot if you have not had one yet. Thismedicine works best if taken as soon as possible after exposure to peoplewho have the flu. If you already have the flu, continuetaking this medicine for the full time of treatment even if you beginto feel better after a few days. This will help to clear up your infectioncompletely. If you stop taking this medicine too soon, your symptoms may return. This medicine should be taken for 5 days.

Inhaled zanamivir is used with a special inhaler and usually comes withpatient directions. Read the directions carefully before using this medicine.If you do not understand the directions or you are not sure how to use theinhaler, ask your health care professional to show you what to do.

To load the inhaler:

• Pull off the blue cover. Make sure the mouthpiece is clean and freeof foreign objects.
• Pull the white mouthpiece until the tray is extended.
• Hold the corners of the white tray and pull out gently until youcan see all the raised ridges on the sides of the tray.
• Put your finger and thumb on the ridges, squeeze inward, and gentlypull the tray out of the body of the inhaler.
• Place a disk on the wheel and then slide the tray back into theinhaler
• To replace the empty disk with a full disk, follow the same stepsyou used to load the inhaler.

To use the inhaler:

• Hold the inhaler flat in your hand.
• A plastic needle will break the blister containing one inhalationof medicine. When the flap is raised as far as it will go, the blister willbe pierced. Do not lift the flap if the cartridge is not in the inhaler. Doingthis will break the needle and you will need a new inhaler.
• After the blister is broken open, close the lid. Keeping the inhalerflat and well away from your mouth, breathe out to the end of a normal breath.
• Raise the inhaler to your mouth, and place the mouthpiece in yourmouth.
• Close your lips around the mouthpiece and tilt your head slightlyback. Do not bite down on the mouthpiece. Do not block the mouthpiece withyour teeth or tongue. Do not cover the air holes on the side of the mouthpiece.
• Breathe in through your mouth as steadily and as deeply as you canuntil you have taken a full deep breath.
• Hold your breath and remove the mouthpiece from your mouth. Continueholding your breath as long as you can up to 10 seconds before breathing out.This gives the medicine time to settle in your airways and lungs.
• Hold the inhaler well away from your mouth and breathe out to theend of a normal breath.
• Prepare the cartridge for your next inhalation. Pull the mouthpieceto extend the tray then push it in until it clicks. The disk will turn tothe next dose. Do not pierce the blister until just before the inhalation.
• Take the second puff following exactly the same steps you used forthe first puff.
• When you are finished, wipe off the mouthpiece and replace the coverto keep the mouthpiece clean and free of foreign objects.

Dosing?Follow your doctor's orders or the directions on the label.

• For treatment of flu (Influenza A and Influenza B)
  • Adults and children 7 years and older ?Two puffs twice daily(approximately 12 hours apart in the morning and evening) for 5 days. Twodoses should be taken on the first day of treatment whenever possible providedthere are at least 2 hours between doses. Zanamivir must be started within48 hours after the onset of signs and symptoms of the flu.
• Canada:
  For treatment of flu (Influenza A and Influenza B)
  • Adults and children 12 years and older ?Two puffs twice daily(approximately 12 hours apart in the morning and evening) for 5 days. Twodoses should be taken on the first day of treatment whenever possible providedthere are at least 2 hours between doses. Zanamivir must be started within48 hours after the onset of signs and symptoms of the flu.

Missed dose?This medicine works best when there is a constant amount inthe lungs. To help keep the amount constant, do not miss any doses. If youmiss a dose of this medicine, use it as soon as possible. If it is almosttime for your next dose, skip the missed dose and go back to your regulardosing schedule. Do not double doses. It is best to take the doses at evenlyspaced times day and night.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Zanamivir willnot keep you from spreading the flu virus to other people. This medicine maycause people with lung disease (chronic obstructive lung disease or asthma)to experience trouble breathing. If this should happen contact your doctorimmediately. Zanamivir may not work in patients with lung disease, heartdisease, or serious medical conditions.

Bronchospasm (wheezing) is a risk for patients with asthma or chronic respiratorydisease. Always have a fast-acting inhaled bronchodilator available for youruse.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause someunwanted effects. Although not all of these side effects may occur, if theydo occur they may need medical attention.

Stop using this medicine and get emergency help immediately if the following side effects occur:

Rare

Other side effectsmay occur that usually do not need medical attention. These side effects maygo away during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome:

Less common