Consumer Information for: RELENZA

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

RELENZA is an antiviral medicine for the treatment of influenza and for reducing the chance of getting the flu in community and household settings.

RELENZA is not a substitute for the flu shot. You should receive an annual flu shot according to guidelines on immunization practices that your doctor can share with you

What influenza is:
The flu, or influenza, is an illness caused by a virus in your respiratory tract. Although the flu virus stays in your respiratory tract and is not carried by the blood, it can often make you feel sick all over.

True influenza is often confused with:

  • the common cold (also caused by viruses)
  • infections caused by bacteria, which may require antibiotics.
Antibiotics have no effect on viruses like the ones that cause influenza or colds. “Stomach flu” that causes vomiting and diarrhea is not related to influenza.

If you have the flu – You might need to be in bed for several days. You probably feel terrible. You will often have a fever, plus some or all of these symptoms:
  • Chills
  • Muscle aches
  • Headache
  • Sore throat
  • Runny or stuffy nose
  • Dry cough
  • Tiredness
These symptoms are caused by your body’s defense system trying to fight the flu virus in your respiratory tract. There are 2 main types of influenza viruses - A and B with several subtypes for each. These viruses change, or mutate, over time. Annual flu shot protects 80 to 85% of the time against one or more of the subtypes of flu that cause infections.

You might be surprised to find that you are still susceptible to flu even though you got your flu shot this year.

There are a few reasons why you may still have the flu:
  • You were infected with the flu before the vaccine could protect you
  • The flu vaccine did not completely protect you against the virus because:
    • the virus may have mutated or changed since the vaccine was developed
    • you may have a weakened immune system
What it does

The influenza virus infects cells that line the inside of your respiratory tract. When RELENZA is inhaled, it helps stop the spread of the influenza virus to healthy cells in your respiratory tract.

With less flu virus in your respiratory tract, you should experience a less severe disease because your body’s defense system doesn’t have to work too hard to fight the virus. That means your flu symptoms should improve.

RELENZA should alleviate the symptoms you are feeling, shorten the duration of your flu (i.e. reduces duration of flu symptoms by about 1 or 2 days) and help you feel better sooner.

RELENZA can also help reduce the chance of getting the flu in persons who have a higher chance of getting the flu because they spend time with someone who has the flu. RELENZA can also reduce the chance of getting the flu if there is a flu outbreak in the community.

When it should not be used

You should not take RELENZA if you are allergic to zanamivir or any component of the zanamivir inhalation powder (see section entitled “What the important nonmedicinal ingredients are”).

What the medicinal ingredient is

RELENZA contains the active ingredient zanamivir (zah-NAmih-veer)

What the non-medicinal ingredients are

RELENZA contains the nonmedicinal ingredient lactose (which contains milk protein).

What dosage form it comes in

RELENZA is a dry powder for inhalation. Each blister of RELENZA contains a dry loose powder mixture of zanamivir and lactose. The lactose acts as a carrier to deliver the medicine to the respiratory tract. The blister protects the powder from the air (until you inhale the powder). The DISKHALER® inhalation device is used to inhale RELENZA directly into your respiratory tract.

Warnings and precautions

Serious Warnings and Precautions

Some patients have had bronchospasm (wheezing) or serious breathing problems when they used RELENZA. Many but not all of these patients had asthma or chronic obstructive pulmonary disease. There is limited data on the use of RELENZA in patients with severe asthma or severe chronic obstructive pulmonary disease. Therefore, RELENZA is not generally recommended for such patients.

If you develop worsening respiratory symptoms such as wheezing or shortness of breath, stop using RELENZA and contact your doctor right away.

If you have chronic respiratory disease such as asthma or chronic obstructive pulmonary disease and your doctor has prescribed RELENZA, you should have a fastacting, 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.

Other kinds of infections can appear like influenza or occur along with influenza and need different kinds of treatment. Contact your doctor if you feel worse or develop new symptoms during or after treatment, or if your influenza symptoms do not start to get better.

BEFORE you use RELENZA talk to your doctor or pharmacist if:

  • you suffer from asthma or chronic respiratory disease.
    Similar to other non-bronchodilator medications that are inhaled as a dry powder, a bronchospasm can occur when using RELENZA and a fast-acting inhaled bronchodilator (e.g. salbutamol) should be available if this occurs.
  • you are pregnant, or likely to become pregnant soon, or if you are breast feeding. If you are pregnant or breast feeding, your doctor will help you decide whether you should take RELENZA.
  • you have any type of chronic condition including lung or heart disease.
  • you are allergic to lactose or milk protein.
Interactions with this medication

It is unlikely that RELENZA will interact with any medications you might be taking. Always be sure to tell your doctor what medications you are using.

Proper use of this medication

Usual Dose

For the Treatment of Influenza: You need to inhale two blisters in the morning and two blisters in the evening. You will use 1 ROTADISK® disk each day for 5 days. RELENZA works best when you start taking it as soon as you begin to feel symptoms and no later than 2 days after flu symptoms start. Take the entire dosage (all 5 ROTADISK® disks) of RELENZA even if you start to feel better before you’ve finished all your medicine.

For the Prevention of Influenza: To reduce the chance of getting the flu, the usual dose is two blisters once daily for 10 or 28 days as prescribed by your doctor.

If you are scheduled to use an inhaled bronchodilator at the same time as RELENZA, you should use your bronchodilator first, before using RELENZA.

See also section entitled “How to take RELENZA” for instructions on how to use the DISKHALER® inhalation device.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose, don’t worry. Take a 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 doctor or pharmacist and follow the advice given to you.

Side effects and what to do about them

Some patients have had breathing problems while taking RELENZA. This can be very serious and needs treatment right away. Most of the patients who had this problem had asthma or COPD but some did not. If you have trouble breathing or have wheezing after your dose of RELENZA, stop taking RELENZA and seek medical attention immediately.

In studies, the most common side effects during treatment with RELENZA have been headaches, diarrhea, nausea, vomiting, nasal irritation, bronchitis, cough, sinusitis, ear, nose and throat infections and dizziness. Other side effects that have been reported, but are not as common include allergic reactions and rashes.

If you are feeling unwell when you take RELENZA you may faint or become lightheaded after inhaling RELENZA. You must sit down in a relaxed position before inhaling the dose of RELENZA, and you must only hold your breath for as long as is comfortable after inhaling the dose. If you are feeling unwell, you are advised to have someone with you while you are inhaling the dose of RELENZA.

People with influenza (the flu), particularly children and adolescents, may be at an increased risk of seizures, confusion, delirium, hallucinations, or abnormal behaviour early in their illness. These events may occur after beginning RELENZA or may occur when flu is not treated. These events are uncommon but may result in accidental injury to the patient. Therefore, patients should be observed for signs of unusual behaviour and a healthcare professional should be contacted immediately if the patient shows any signs of unusual behaviour.

Please refer to the section entitled “Serious Warnings and Precautions” and the table below for additional information.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist only if severe Talk with your doctor or pharmacist in all cases Stop taking drug and call your doctor or pharmacist
Very rare
Bronchospasm (involuntary contraction of the smooth muscles of the airway passages) with symptoms such as difficulty in breathing and wheezing.   ✔ ✔
Allergic reaction such as swelling of the face or in the mouth or throat; or itchy, raised skin rash (hives); or breathing problems (shortness of breath or wheezing), or collapse.   ✔ ✔
Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)   ✔ ✔
Widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens Johnson Syndrome)   ✔ ✔
Extensive peeling of the skin on much of the body surface (toxic epidermal necrolysis)   ✔ ✔

If you notice any of the symptoms listed in the table above stop taking RELENZA and contact a doctor urgently.

This is not a complete list of side effects. For any unexpected effects while taking RELENZA, contact your doctor or pharmacist.

How to store

Store at room temperature (15 to 30°C) in a dry place. Use the ROTADISK® disk before the expiration date. Do not puncture any RELENZA ROTADISK® disk blister until you are ready to inhale a dose of RELENZA.

Keep RELENZA and the DISKHALER® inhalation device in a safe place away from children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice

More information

This document plus the full product monograph, prepared for health professionals can be found at:
http://www.gsk.ca or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374

This leaflet was prepared by GlaxoSmithKline Inc.

Last revised: July 20, 2018

© 2018 GSK Group of companies or its Licensor. Trademarks are owned by or licensed to the GSK group of companies.

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