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Details for: ADVAIR

Company: GLAXOSMITHKLINE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02245126ADVAIR 125SALMETEROL (SALMETEROL XINAFOATE); FLUTICASONE PROPIONATE25 MCG / ACT; 125 MCG / ACTAEROSOL, METERED DOSEINHALATION
02245127ADVAIR 250SALMETEROL (SALMETEROL XINAFOATE); FLUTICASONE PROPIONATE25 MCG / ACT; 250 MCG / ACTAEROSOL, METERED DOSEINHALATION
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Asthma (patients 12 years of age or 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 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 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 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.

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

Do not use ADVAIR if you:

  • Are allergic or have had an allergic reaction to fluticasone propionate, salmeterol xinafoate.
  • 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

CFC-free propellant, HFA.

What dosage form it comes in

ADVAIR pressurised inhalation, suspension is a pressurized metered dose inhaler containing 125 or 250 mcg of fluticasone propionate, and 25 mcg of salmeterol per inhalation.

Warnings and precautions

Serious Warnings and Precautions

ADVAIR is not for the treatment of acute asthma attacks.If you get a sudden attack of wheezing and breathlessness between your doses of ADVAIR, 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 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.
  • 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 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.

Asthma:After you start taking ADVAIR, 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. Do not stop or change the dose of your ADVAIR 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 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 without talking to your doctor.

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 include:

  • medicines similar to ADVAIR 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.
Proper use of this medication

It is very important that you use 2 puffs of ADVAIR 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.

It is very important that you use ADVAIR regularly every day. Do not stop taking ADVAIR 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 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.

Spacer devices (holding chamber) may be used in patients who have difficulty coordinating the actuation of a metered dose inhaler with inhalation. Talk to your doctor before using ADVAIR with a spacer device because your dose may need to be changed. If using a spacer device, follow the manufacturer’s instructions.

Usual Asthma Dose:
For patients 12 years of age and older, the usual dose is: Two inhalations ADVAIR 125 pressurized inhalation, suspension twice daily
or
Two inhalations ADVAIR 250 pressurized inhalation, suspension twice daily.

At present, there are insufficient clinical data to recommend the use of ADVAIR in children younger than 12 years of age.

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 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 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.

How to Prime ADVAIR:
Before you use your ADVAIR for the first time, remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well and release a puff into the air and repeat until the counter reads 120 to make sure that it works. If your inhaler has not been used for a week or more, remove the mouthpiece cover, shake the inhaler well and release a puff into the air; repeat for a second puff. Each time the inhaler is activated, the number on the counter will count down by one after each actuation. In some circumstances, dropping the inhaler may cause the counter to count down.

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

After use, always replace the mouthpiece cover immediately to keep out dust and fluff. REPLACE MOUTHPIECE COVER FIRMLY AND PUSH INTO POSITION. The cover must be replaced in the correct orientation; otherwise, the cover will not fit properly. Do not force; the cover will click into position if it is replaced in the correct orientation. If the cover is upside down, it will not be possible to fully replace it. If this happens, remove the cover, rotate it and try again.

  1. Open
    To remove the snap-on mouthpiece cover, hold between the thumb and forefinger, squeeze gently and pull apart as shown. Check inside and outside of the inhaler including the mouthpiece for the presence of loose objects. Your inhaler is now ready to use.
  2. Shake
    Shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.
  3. Exhale
    Hold the inhaler upright between your fingers and thumb with your thumb on the base, below the mouthpiece. Breathe out as far as is comfortable. Once you have fully exhaled, place the mouthpiece between your teeth without biting, and close your lips around it.
  4. Inhale
    Just after starting to breathe in through your mouth, press down firmly on the top of the inhaler while still breathing in steadily and deeply.

    Remove the inhaler from your mouth and hold your breath for 10 seconds or as long as is comfortable. Breathe out slowly.

    Each time the inhaler is activated, the number on the counter will count down by one.

    Each prescribed dose is usually given by a minimum of 2 puffs. Before taking your next puff, hold the inhaler upright and wait 30 seconds before repeating steps 2 through 4.

    To keep out dust and lint, replace the mouthpiece cover by firmly pushing and snapping the cover into position in the correct orientation. If it does not click into place, turn the cover the other way round and try again. Do not use excessive force.

  5. Rinse
    Rinse out your mouth and gargle with water after each dose. Do not swallow the water.

To get the most from your treatment, remember to take 2 puffs of ADVAIR twice a day, every day or as prescribed by your doctor.

Important
Do not rush stage 4. It is important that you start to breathe in as slowly as possible just before operating your inhaler. Practice in front of a mirror for the first few times. If you see "mist" coming from the top of your inhaler or the sides of your mouth, you should start again from stage 2.

If your doctor has given you different instructions for using your inhaler, please follow them carefully. Tell your doctor if you have any difficulties.

You should get a replacement when the counter shows the number 020. The counter will stop at 000 when all of the recommended puffs have been used. Stop using the inhaler when the counter reads 000.

Never try to alter the numbers on the counter or detach the counter from the metal can. The counter cannot be reset and is permanently attached to the can.

Children/Elderly
Some children may need help and an adult may need to operate the inhaler for them. Encourage the child to breathe out and operate the inhaler just after the child starts to breathe in. Practice the technique together. Children or people with weak hands should hold the inhaler with both hands. Put the two forefingers on top of the inhaler and both thumbs on the base below the mouthpiece.

Cleaning
To prevent your inhaler blocking up, it is important to clean it at least once a week, following the instructions below. If your inhaler does block up, the same cleaning instructions should be followed. If you notice a build up of medicine around the mouthpiece, do not attempt to unblock it with a sharp object, such as a pin.

To clean your inhaler:

  1. Remove the mouthpiece cover.
  2. Do not remove the canister from the plastic casing.
  3. Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth, tissue or cotton swab. Do not put the metal canister into water.
  4. Replace the mouthpiece cover.
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. 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, contact your doctor or pharmacist.

How to store

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

After use, replace the mouthpiece cover firmly and snap it into position. Do not use excessive force.

Store ADVAIR between 15°C and 25°C. Protect from frost and direct sunlight.

As with most inhaled medications in pressurized canisters, the therapeutic effect of this medication may decrease when the canister is cold. If the inhaler becomes very cold, remove the metal canister and warm in your hand for a few minutes. Never use other forms of heat.

Warning - The metal canister is pressurized. Do not puncture it or burn it, even when apparently empty.

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

© 2020 GSK group of companies or its licensor Trademarks are owned by or licensed to the GSK group of companies.

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