ADVAIR DISKUS ADVAIR - GlaxoSmithKline

More documents

Recommendations

Info

IMPORTANT: PLEASE READ SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM Symptom / effect Rare Churg-Strauss syndrome: a flulike 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. Talk with your doctor or pharmacist Only if severe In all cases √ √ √ √ Stop taking drug and seek immediate emergency medical attention √ SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM Symptom / effect Very rare Unknown Sudden worsening of shortness of breath and wheezing shortly after using ADVAIR ® . Mouth, throat becomes unusually irritated causing high pitched wheezing and choking Esophageal candidiasis: Yeast infection of the esophagus (food tube); difficulty swallowing Persistent pain and/or limited range of motion of a joint or a limb. Decreased ability to fight infections. Symptoms of infection may include fever, pain, chills, feeling tired and sore throat Talk with your doctor or pharmacist Only if severe √ In all cases √ √ √ Stop taking drug and seek immediate emergency medical attention Worsening of √ lung symptoms such as wheezing, shortness of breath, cough and chest tightness *Symptoms of pneumonia and COPD exacerbations frequently overlap. √ July 29, 2014 Page 66 of 67
IMPORTANT: PLEASE READ This is not a complete list of side effects. For any unexpected effects while taking ADVAIR ® , 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. 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. 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 and VENTOLIN are registered trademarks, used under license by GlaxoSmithKline Inc. 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: • 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 67 of 67
Page 1 and 2:
Pr ADVAIR ® DISKUS ® salmeterol x
Page 3 and 4:
Pr ADVAIR ® DISKUS ® salmeterol x
Page 5 and 6:
WARNINGS AND PRECAUTIONS General In
Page 7 and 8:
Endocrine And Metabolism Systemic S
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 and 60: IMPORTANT: PLEASE READ SERIOUS SIDE
Page 61 and 62: IMPORTANT: PLEASE READ PART III: CO
Page 63 and 64: IMPORTANT: PLEASE READ INTERACTIONS
Page 65: IMPORTANT: PLEASE READ SIDE EFFECTS
show all

ADVAIR DISKUS ADVAIR - GlaxoSmithKline

Create successful ePaper yourself

Delete template?

Save as template?