ADVAIR DISKUS ADVAIR - GlaxoSmithKline
ADVAIR DISKUS ADVAIR - GlaxoSmithKline ADVAIR DISKUS ADVAIR - GlaxoSmithKline
IMPORTANT: PLEASE READ 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 IT Keep your medicine in a safe place where children cannot reach it. Your medicine may harm them. Do not store ADVAIR ® DISKUS ® above 25°C. Keep in a dry place. Remember Keep your DISKUS ® dry. Keep it closed when not in use. REPORTING SUSPECTED 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: MORE INFORMATION Patients can refer to www.advair.ca or call 1-877-444-2494 for further 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 Canada L5N 6L4 1-800-387-7374 This leaflet was prepared by GlaxoSmithKline Inc. Last Revised: July 29, 2014 © 2014 GlaxoSmithKline Inc. All Rights Reserved ® ADVAIR, DISKUS and VENTOLIN are registered trademarks, used under license by GlaxoSmithKline Inc. • Report online at www.healthcanada.gc.ca/medeffect • Call toll-free at 1-866-234-2345 • Complete a Canada Vigilance Reporting Form and: o Fax toll-free to 1-866-678-6789, or o Mail to: Canada Vigilance Program Health Canada Postal Locator 0701E Ottawa, Ontario K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/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. July 29, 2014 Page 60 of 67
IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION Pr ADVAIR ® salmeterol xinafoate/fluticasone propionate inhalation aerosol This leaflet is part III of a three-part "Product Monograph" for ADVAIR ® and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about ADVAIR ® . Contact your doctor or pharmacist if you have any questions about the drug. ABOUT THIS MEDICATION 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. 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. ADVAIR ® should not be the first asthma medication you use unless advised by your doctor. It is only used when a regular inhaled corticosteroid medicine along with a fast acting ‘reliever’ medicine, such as salbutamol (e.g. VENTOLIN ® ) are not adequately helping you with your breathing problems. ADVAIR ® helps to prevent breathlessness and wheezing from happening due to asthma. breathing problems. 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 (e.g., VENTOLIN ® ) 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 salmeterol xinafoate, fluticasone propionate. • Have a medical history of cardiac tachyarrhythmias (problems of your heart beating fast and/or irregularly). • Have a fungal, bacterial or tuberculosis infection. • Have moderate to severe bronchiectasis (a lung condition). What the medicinal ingredients are: salmeterol xinafoate and fluticasone propionate. What the nonmedicinal ingredients are: CFC-free propellant, HFA. What dosage forms it comes in: ADVAIR ® inhalation aerosol is a pressurized metered dose inhaler containing 25 mcg of salmeterol, and 50*, 125 or 250 mcg of fluticasone propionate per inhalation. *ADVAIR ® 50 is not available in Canada 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, salmeterol xinafoate and fluticasone propionate. Salmeterol xinafoate is a bronchodilator. 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. Fluticasone propionate is a corticosteroid. Corticosteroids are used to treat breathing problems because they have an antiinflammatory action. They reduce the swelling and irritation in the walls of the small air passages in the lungs and so ease July 29, 2014 Page 61 of 67
- Page 9 and 10: The results of a drug interaction s
- Page 11 and 12: Ophthalmologic (Glaucoma and Catara
- Page 13 and 14: Since there is no experience with u
- Page 15 and 16: MedDRA preferred term Musculoskelet
- Page 17 and 18: Table 2 Number (and percentage) of
- Page 19 and 20: The following table includes all ev
- Page 21 and 22: Other COPD Clinical Trial Adverse D
- Page 23 and 24: Very rare: Anaphylactic shock or an
- Page 25 and 26: Drug-Drug Interactions Table 5 Esta
- Page 27 and 28: Recommended Dose And Dosage Adjustm
- Page 29 and 30: trauma, surgery or infection or any
- Page 31 and 32: significant increase in plasma salm
- Page 33 and 34: ADVAIR ® inhalation aerosol compri
- Page 35 and 36: Partition Coefficient: The partitio
- Page 37 and 38: In a randomized, double-blind, acti
- Page 39 and 40: ADVAIR ® / ADVAIR ® DISKUS ® are
- Page 41 and 42: Study Demographics and Trial Design
- Page 43 and 44: consistent with the recommended use
- Page 45 and 46: Clinical Studies in COPD Clinical s
- Page 47 and 48: There was no evidence that the syst
- Page 49 and 50: man. The change was characterized b
- Page 51 and 52: Focal coronary arteritis occurred t
- Page 53 and 54: 11. Greening AP, Ind PW, Northfield
- Page 55 and 56: IMPORTANT: PLEASE READ WARNINGS AND
- Page 57 and 58: IMPORTANT: PLEASE READ Then go on a
- Page 59: IMPORTANT: PLEASE READ SERIOUS SIDE
- Page 63 and 64: IMPORTANT: PLEASE READ INTERACTIONS
- Page 65 and 66: IMPORTANT: PLEASE READ SIDE EFFECTS
- Page 67: IMPORTANT: PLEASE READ This is not
IMPORTANT: PLEASE READ<br />
overlap.<br />
This is not a complete list of side effects. For any unexpected<br />
effects while taking <strong>ADVAIR</strong> ® <strong>DISKUS</strong> ® , contact your doctor or<br />
pharmacist.<br />
HOW TO STORE IT<br />
Keep your medicine in a safe place where children cannot<br />
reach it. Your medicine may harm them.<br />
Do not store <strong>ADVAIR</strong> ® <strong>DISKUS</strong> ® above 25°C. Keep in a dry<br />
place.<br />
Remember<br />
Keep your <strong>DISKUS</strong> ® dry.<br />
Keep it closed when not in use.<br />
REPORTING SUSPECTED SIDE EFFECTS<br />
You can report any suspected adverse reactions<br />
associated with the use of health products to the Canada<br />
Vigilance Program by one of the following 3 ways:<br />
MORE INFORMATION<br />
Patients can refer to www.advair.ca or call 1-877-444-2494 for<br />
further information.<br />
You may need to read this package insert again. Please do not<br />
throw it away until you have finished your medicine. This<br />
document plus the full product monograph, prepared for health<br />
professionals can be found at:<br />
http://www.gsk.ca or by contacting the sponsor,<br />
<strong>GlaxoSmithKline</strong> Inc., at:<br />
7333 Mississauga Road<br />
Mississauga, Ontario<br />
Canada L5N 6L4<br />
1-800-387-7374<br />
This leaflet was prepared by <strong>GlaxoSmithKline</strong> Inc.<br />
Last Revised: July 29, 2014<br />
© 2014 <strong>GlaxoSmithKline</strong> Inc. All Rights Reserved<br />
® <strong>ADVAIR</strong>, <strong>DISKUS</strong> and VENTOLIN are registered trademarks, used<br />
under license by <strong>GlaxoSmithKline</strong> Inc.<br />
• Report online at www.healthcanada.gc.ca/medeffect<br />
• Call toll-free at 1-866-234-2345<br />
• Complete a Canada Vigilance Reporting Form and:<br />
o Fax toll-free to 1-866-678-6789, or<br />
o Mail to: Canada Vigilance Program<br />
Health Canada<br />
Postal Locator 0701E<br />
Ottawa, Ontario<br />
K1A 0K9<br />
Postage paid labels, Canada Vigilance<br />
Reporting Form and the adverse reaction<br />
reporting guidelines are available on the<br />
MedEffect Canada Web site at<br />
www.healthcanada.gc.ca/medeffect.<br />
NOTE: Should you require information related to the<br />
management of side effects, contact your health<br />
professional. The Canada Vigilance Program does not<br />
provide medical advice.<br />
July 29, 2014<br />
Page 60 of 67
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