Consumer Information for: ADVAIR

What the medication is used for

Asthma (patients 4 years old and older):
Asthma is a chronic inflammatory disease of the lungs characterized by episodes of difficulty in breathing. People with asthma have extra sensitive or "twitchy" airways. During an asthma attack, the airways react by narrowing, making it more difficult for the air to flow in and out of the lungs.

ADVAIR DISKUS should be used in patients:

who have asthma that is not adequately controlled with a long-term asthma medication such as an inhaled corticosteroid (ICS) alone; or
whose asthma severity requires treatment with both an ICS and long-acting beta2 agonist (LABA).

ADVAIR DISKUS should not be the first asthma medication you use unless advised by your doctor. It is only used when a regular ICS medicine along with a fast acting ‘reliever’ medicine, such as salbutamol are not adequately helping you with your breathing problems. ADVAIR DISKUS helps to prevent breathlessness and wheezing from happening due to asthma.

Control of asthma requires avoiding irritants that cause asthma attacks and taking the appropriate medications. For example, patients should avoid exposure to house dust mites, mold, pets, tobacco smoke and pollens.

Chronic Obstructive Pulmonary Disease (COPD):
COPD is a type of lung disease in which there is often a permanent narrowing of the airways, leading to breathing difficulties. In many patients, this narrowing of the airways is a result of many years of cigarette smoking. If you suffer from COPD, you must stop smoking to prevent further lung damage. Please contact your physician or other health care provider for help in smoking cessation.

ADVAIR DISKUS is to be used for the long-term control of symptoms due to COPD and to prevent wheezing in adults with COPD.

This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

What it does

ADVAIR DISKUS contains two medicinal ingredients, fluticasone propionate and salmeterol xinafoate. Fluticasone propionate is an inhaled corticosteroid. Corticosteroids are used to treat breathing problems because they have an anti-inflammatory action. They reduce the swelling and irritation in the walls of the small air passages in the lungs and so ease breathing problems.

Salmeterol xinafoate is a LABA. It relaxes the muscles in the walls of the small air passages in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs. The effects of salmeterol xinafoate last for at least 12 hours. When it is taken regularly with an inhaled corticosteroid, it helps the small air passages to remain open.

Corticosteroids also help to prevent attacks of asthma. When you take these two ingredients together regularly they will both help to control your breathing difficulties.

When it should not be used

ADVAIR DISKUS does not act quickly enough to provide relief from a sudden attack of breathlessness or wheezing due to asthma or COPD. A fast acting ‘reliever’ medicine, such as salbutamol should be used for any sudden attacks of breathlessness or wheezing (e.g., asthma attacks).

Remember:
Do not use ADVAIR DISKUS if you:

Are allergic or have had an allergic reaction to fluticasone propionate, salmeterol xinafoate.
Are allergic to lactose (milk sugar) or milk protein.
Have a medical history of cardiac tachyarrhythmias (problems of your heart beating fast and/or irregularly).
Have an untreated fungal, bacterial or tuberculosis infection.

What the medicinal ingredient is

fluticasone propionate and salmeterol xinafoate.

What the non-medicinal ingredients are

lactose (milk sugar) and milk protein.

What dosage form it comes in

ADVAIR DISKUS is an inhalation powder administered through a plastic inhaler device containing a foil strip with 28 or 60 blisters. Each blister contains 100, 250, or 500 mcg of fluticasone propionate and 50 mcg of salmeterol (as the xinafoate salt) per inhalation.

Warnings and precautions

Serious Warnings and Precautions

ADVAIR DISKUS is not for the treatment of acute asthma attacks or sudden increase of breathlessness and wheezing in COPD. If you get a sudden attack of wheezing and breathlessness between your doses of ADVAIR DISKUS, you should use your fast acting ‘reliever’ medicine, such as salbutamol which your doctor has prescribed to you. Use the medication as directed by your doctor.

You may need to also take steroid tablets or syrup during a severe asthma attack, during other illnesses or during times of stress. Your doctor may give you some steroid tablets or syrup to carry with you as well as a steroid warning card, which will give you advice on when and how to use them.

Before and while you use ADVAIR DISKUS talk to your doctor or pharmacist if the following situations apply to you so that they can determine whether you should start or continue taking this medication:

Have eye problems such as glaucoma, cataracts, blurry vision or other changes in vision.
Are suffering from any chest infection (cold, bronchitis).
Have ever had to stop taking another medication for your breathing problems because you were allergic to it or it caused problems.
Have been told you are allergic to lactose (milk sugar) or milk protein.
Ever had a yeast infection (thrush) in your mouth.
Are having treatment for a thyroid condition.
Have diabetes.
Have high blood pressure.
Have heart problems.
Have had tuberculosis (TB) infections.
Are taking other “steroids” by mouth or by inhalation.
Are pregnant, planning to become pregnant or breastfeeding.
Are taking a medicine called ketoconazole, used to treat fungal infection.
Are taking medicines used to treat HIV infection (e.g. ritonavir, atazanavir, indinavir, nelfinavir, saquinavir and cobicistat containing products).
Have liver problems or cirrhosis.

You should avoid coming into contact with anyone who has measles or the chicken pox while taking an ICS. If you or your child are exposed, tell your doctor right away.

Drugs like ADVAIR DISKUS can cause eye disorders:

Cataracts: Clouding of the lens in the eye, blurry vision, eye pain;
Glaucoma: An increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss;
Central serous chorioretinopathy (CSCR): blurry vision or other changes in vision.

Contact your healthcare professional if you experience blurry vision or other vision problems. You should have regular eye exams.

Other warnings you should know about:

Asthma specific warnings:
After you start taking ADVAIR DISKUS, your doctor may change the dosages of your other asthma medicines. Rarely, this may make a patient feel worse rather than better. This especially applies to oral corticosteroids (sometimes referred to as steroids), including prednisone. If your doctor decreases your oral steroid dose, and you become unwell, tell your doctor immediately.

You should have your asthma assessed at regular intervals as agreed upon with your doctor. Once control of your asthma is achieved and maintained, your doctor may further adjust your dose of ADVAIR DISKUS. Do not stop or change the dose of your ADVAIR DISKUS unless your doctor has advised you to do so.

When LABA medicines are used alone without an ICS, they increase the risk of hospitalization and death from asthma problems. ADVAIR DISKUS contains both an ICS and LABA. Studies showed that when an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

Tell your doctor immediately if:

There is a change in your symptoms such as more coughing, attacks of wheezing, chest tightness, or an unusual increase in the severity of the breathlessness.
You wake up at night with chest tightness, wheezing or shortness of breath.
You use increasing amounts of your fast acting ‘reliever’ medicine.

These could be warning signs that your condition may be worsening. Do not stop taking ADVAIR DISKUS without talking to your doctor.

COPD specific warnings:

Tell your doctor immediately if you notice symptoms of a ‘flare up”.
Patients with COPD have a higher chance of getting pneumonia (a lung infection). Drugs like ADVAIR DISKUS may also increase your chance of getting pneumonia. However, symptoms of pneumonia and COPD ‘flare ups’ frequently overlap. It is therefore important you tell your doctor immediately if you suspect an infection, as even mild chest infections should be treated immediately. Your doctor may also recommend that you receive a flu shot each year.

You should avoid close contact with people who have colds or the flu (influenza). You should ask your doctor about flu vaccination.

The following warning signs indicate that your COPD condition may be worsening. You should contact your doctor as soon as possible if you notice:

An unusual increase or decrease in the amount of phlegm.
An unusual increase in the consistency and stickiness of the phlegm.
The presence of blood in phlegm.
A change in the colour of the phlegm to either brown, yellow or green.
An unusual increase in the severity of the breathlessness, cough or wheeze.
Symptoms of a cold (e.g., sore throat).
Unexplained tiredness or fever.
Chest tightness.
Unexplained swelling.
The necessity to increase the number of pillows in order to sleep in comfort.

Interactions with this medication

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

Drugs that may interact with ADVAIR DISKUS include:

medicines similar to ADVAIR DISKUS used for your lung disease, as it may increase the risk of experiencing possible side effects. This includes other medicines containing a LABA or a corticosteroid.
medicines used to treat HIV infection or AIDS (e.g. ritonavir, atazanavir, indinavir, nelfinavir, saquinavir and cobicistat containing products).
ketoconazole (used to treat fungal infections).
beta-blockers used in the treatment of high blood pressure or other heart problems (e.g. propranolol) or in the treatment of glaucoma.
medicines used to treat depression (i.e., tricyclic antidepressants, monoamine oxidase inhibitors).
medicines used to decrease the level of potassium in your blood (i.e., diuretics). These are also known as “water pills” and are used to treat high blood pressure.
methylxanthines (such as theophylline) used to treat asthma and COPD.

Proper use of this medication

It is very important that you use your ADVAIR DISKUS every day, twice a day, even if you have no symptoms. This will help you to keep free of symptoms throughout the day and night. You should not use it more than twice a day. If you take more than one inhaled medicine, make sure you understand the purpose for taking each medication and when you should use them.

Do not stop taking ADVAIR DISKUS suddenly, even if you feel better. Your doctor can provide you with information about how to slowly stop the medication if necessary. Do not change your dose unless told to by your doctor. If you have to go into hospital for an operation, take your ADVAIR DISKUS with you and tell the doctor what medicine(s) you are taking. If your doctor decides to stop the treatment, do not keep any left- over medicine unless your doctor tells you to.

Usual Asthma Dose:

For patients 12 years of age and older, the usual dose is:
One inhalation ADVAIR DISKUS 100 twice daily
or One inhalation ADVAIR DISKUS 250 twice daily
or One inhalation ADVAIR DISKUS 500 twice daily.
For children 4 to 11 years of age the usual dose is:
One inhalation ADVAIR DISKUS 100 twice daily.

At present, there are insufficient clinical data to recommend the use of ADVAIR DISKUS in children younger than 4 years of age.

Usual COPD Dose:

The usual dose for adults (18 years and older) is:
One inhalation ADVAIR DISKUS 250 twice daily
or One inhalation ADVAIR DISKUS 500 twice daily

If you are troubled with mucus, try to clear your chest as completely as possible by coughing before you use ADVAIR DISKUS. This will allow ADVAIR DISKUS to pass more deeply into your lungs.

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.

If you accidentally take a larger dose than recommended, you may notice that your heart is beating faster than usual and that you feel shaky. Other symptoms you may experience include headache, muscle weakness and aching joints.

Excessive use of medication can be extremely dangerous. If you have used a larger than allowed recommended dose of ADVAIR DISKUS for a long period of time (months or years), you should talk to your doctor or pharmacist for advice. A gradual reduction of your dose may be needed. Do not stop taking the medication suddenly.

Missed Dose

It is very important that you use ADVAIR DISKUS regularly. If you forget to inhale a dose do not worry, inhale another as soon as you remember but if it is near to the time for the next dose, wait until it is due. Do not take a double dose. Then go on as before.

About your ADVAIR DISKUS:
The ADVAIR DISKUS inhaler is packaged in a plastic-coated, moisture-protective foil pouch. Do not open the foil pouch until you are ready to use the inhaler. When you take your DISKUS out of its foil pouch, it will be in the closed position. Safely throw away the pouch. Write the “Discard by” date in the first blank line on the label. This date is 1 month from the date you have opened the foil pouch.

The blisters protect the powder for inhalation from effects of the atmosphere.

A new DISKUS contains 28 or 60 individually protected doses of your medicine, in powder form. The device has a dose counter which tells you the number of doses remaining. It counts down from 28 or 60 to 1. To show when the last five doses have been reached the numbers appear in red.

Each dose is accurately measured and hygienically protected. The DISKUS requires no maintenance, and no refilling.

How to use your ADVAIR DISKUS properly:
It is important that you take each dose as instructed by your doctor, nurse, or pharmacist. Your doctor will decide which strength of DISKUS you should use.

When you need a dose, just follow the six simple steps illustrated: 1. Open, 2. Slide, 3. Exhale, 4. Inhale, 5. Close, 6. Rinse.

Sliding the lever of your DISKUS opens a small hole in the mouthpiece and unwraps a dose ready for you to inhale it. When you close the DISKUS, the lever automatically moves back to its original position ready for your next dose when you need it. The outer case protects your DISKUS when it is not in use.

Open
To open your DISKUS hold the outer case in one hand and put the thumb of your other hand on the thumb grip. Push the thumb grip away from you, until you hear it click into place.

Slide
Hold your DISKUS with the mouthpiece towards you. Slide the lever away until you hear another click. Your DISKUS is now ready to use.
Every time the lever is pushed back a dose is made available for inhaling. This is shown by the dose counter. Do not play with the lever as this releases doses which will be wasted.

Exhale
Hold the DISKUS away from your mouth. Breathe out as far as is comfortable. Remember – never exhale into your DISKUS.

Inhale
Before you start to inhale the dose, read through this section carefully.
Once you have fully exhaled, place the mouthpiece to your mouth and close your lips around it. Breathe in steadily and deeply through your mouth until a full breath is taken
Remove the DISKUS from your mouth. Hold your breath for 10 seconds or as long as is comfortable. Breathe out slowly.

You may not be able to taste or feel the powder on your tongue, even if you have used the DISKUS correctly.

5. Close
To close your DISKUS, place your thumb in the thumb grip, and slide it back until you hear a click. The lever is now automatically reset for your next use. The counter on the DISKUS indicates how many doses are remaining.

Rinse
Rinse out your mouth and gargle with waterafter each dose. Do not swallow the water.
To get the most from your treatment, remember to take one inhalation of ADVAIR DISKUS twice a day, everyday or as prescribed by your doctor.

Side effects and what to do about them

Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. If you experience any side effects that bother you, please contact your doctor. This includes the following side effects, which usually wear off with continued treatment:

Effects on heart

faster heart beat than usual

Effects on muscles and joints

pain in joints
muscle cramps

Effects on nervous system

feeling a little shaky
headache
behavioural changes (including agitation, anxiety, and irritability)
disturbed sleep
fainting
spinning sensation (vertigo)
dizziness

Other Effects

hoarseness and voice changes
increased bruising

It is very important that you use your medicine regularly to control your asthma and to ask your doctor whether you need to be monitored in any special way.
Special attention should be paid if you:

were previously taking another form of corticosteroids (like an injection or an oral tablet) and have switched to an ICS, to look out for tiredness, weakness, nausea and vomiting, low blood pressure.
are being treated for diabetes as you may need more frequent blood sugar monitoring or a dosage adjustment of your diabetes medication.
develop a mild yeast infection of the mouth or throat (thrush, Candidiasis) or, rarely, in the esophagus. Common signs are white, slightly raised, sore patches on your tongue and inner cheeks. Remember to rinse and gargle your mouth with water and spit after using ADVAIR DISKUS. Cleaning dentures may also help.
are a child or adolescent with asthma, as your growth should be monitored regularly by a physician when being treated with corticosteroids. Studies have also shown that children whose asthma is not controlled do not grow as quickly as other children.

Serious side effects and what to do about them
Symptom / effect	Talk to your healthcare professional Only if severe	Talk to your healthcare professional In all cases	Stop taking drug and get immediate medical help
Common
Thrush: yeast infection of the mouth or throat; thick white patches in the mouth, tongue or on the throat, sore throat		✔
Pneumonia (in COPD patients), symptoms such as increased cough with increase in mucus (sputum) production, fever accompanied by shaking chills, shortness of breath, sharp or stabbing chest pain during deep breaths, and increased rapid breathing.*		✔
Uncommon
Allergic reactions: lumpy skin rash or hives anywhere on the body.			✔
Fast or irregular heartbeat that does not go away on its own		✔
Increase amount of sugar in blood (excessive thirst, frequent urination, dry skin, blurred vision and fatigue)		✔
Blurry vision or eye pain (cataracts)		✔
Rare
Eosinophilic granulomatosis with polyangiitis: a flu-like illness, rash, pins and needles or numbness of arms or legs, severe sinusitis and worsening lung or breathing problems		✔
Low blood potassium: muscle weakness and muscle spasms		✔
Rounded face, loss of bone density, blurry vision or eye pain (glaucoma), slowing of growth in children and adolescents		✔
Decreased adrenal function: symptoms may include tiredness, weakness, nausea and vomiting, low blood pressure		✔
Allergic reactions: sudden wheeziness and chest pain or tightness; or swelling of eyelids, face, lips, tongue or throat.			✔
Sudden worsening of shortness of breath and wheezing shortly after using ADVAIR DISKUS.			✔
Mouth, throat becomes unusually irritated causing high pitched wheezing and choking		✔
Esophageal candidiasis: Yeast infection of the esophagus (food tube); difficulty swallowing		✔
Very Rare
Persistent pain and/or limited range of motion of a joint or a limb.		✔
Unknown
Decreased ability to fight infections. Symptoms of infection may include fever, pain, chills, feeling tired and sore throat	✔
Worsening of lung symptoms such as increased shortness of breath, wheezing, cough and chest tightness accompanied by fever and more phlegm		✔

*Symptoms of pneumonia and COPD exacerbations frequently overlap.

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

How to store

Keep out of reach and sight of children. Your medicine may harm them.

Do not store ADVAIR DISKUS above 25°C. Keep in a dry place, away from direct heat or sunlight. Store ADVAIR DISKUS in the unopened foil pouch and only open when ready for use. Discard ADVAIR DISKUS 1 month after you open the foil pouch or when the counter reads 0, whichever comes first.

Remember
Keep your DISKUS dry and away from direct heat or sunlight. Keep it closed when not in use.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Report online at MedEffect
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
  Canada Vigilance Program
  Health Canada
  Postal Locator 1908C
  Ottawa, Ontario
  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

You may need to read this package insert again. Please do not throw it away until you have finished your medicine. 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., at:
7333 Mississauga Road
Mississauga, Ontario L5N 6L4
1-800-387-7374

This leaflet was prepared by GlaxoSmithKline Inc.

Last Revised: June 17, 2020

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