Prescribing Information PARNATE - GlaxoSmithKline
Prescribing Information PARNATE - GlaxoSmithKline
Prescribing Information PARNATE - GlaxoSmithKline
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IMPORTANT: PLEASE READ<br />
Rare<br />
SERIOUS SIDE EFFECTS, HOW OFTEN THEY<br />
HAPPEN AND WHAT TO DO ABOUT THEM<br />
See<br />
Warnings &<br />
Precautions<br />
Symptom / effect<br />
Allergic reactions<br />
including but not<br />
limited to red and<br />
lumpy skin rash,<br />
hives, swelling in the<br />
mouth, tongue, face<br />
and throat, itching,<br />
rash, trouble<br />
breathing<br />
New or Worsened<br />
Emotional or<br />
Behavioral Problems<br />
Hypertensive crisis<br />
[severe or frequent<br />
headaches, chest<br />
pain, fast or slow<br />
heartbeat, neck<br />
stiffness or soreness,<br />
sweating with initial<br />
paleness followed by<br />
flushing of the skin,<br />
enlarged pupils,<br />
nausea and vomiting]<br />
Talk with<br />
your<br />
doctor or<br />
pharmacist<br />
Seek<br />
immediate<br />
medical<br />
emergency<br />
assistance.<br />
This is not a complete list of side effects. For any unexpected<br />
effects while taking <strong>PARNATE</strong> ® , contact your doctor or<br />
pharmacist.<br />
HOW TO STORE IT<br />
<strong>PARNATE</strong> ® should be stored between 15 and 30°C. Keep<br />
<strong>PARNATE</strong> ® out of reach of children.<br />
<br />
<br />
<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 />
• 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 />
- Fax toll-free to 1-866-678-6789, or<br />
- Mail to: Canada Vigilance Program<br />
Health Canada<br />
Postal Locator 0701E<br />
Ottawa, ON K1A 0K9<br />
Postage paid labels, Canada Vigilance Reporting Form<br />
and the adverse reaction reporting guidelines are<br />
available on the 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 />
MORE INFORMATION<br />
This document plus the full product monograph, prepared for<br />
health professionals can be found at:<br />
http://www.gsk.ca or by contacting the sponsor,<br />
<strong>GlaxoSmithKline</strong> Inc.<br />
7333 Mississauga Road<br />
Mississauga, Ontario<br />
L5N 6L4<br />
1-800-387-7374<br />
This leaflet was prepared by <strong>GlaxoSmithKline</strong> Inc.<br />
Last revised: June 19, 2013<br />
© 2013 <strong>GlaxoSmithKline</strong> Inc. All Rights Reserved<br />
® <strong>PARNATE</strong> is a registered trademark, used under license by<br />
<strong>GlaxoSmithKline</strong> Inc.<br />
22 June 19, 2013
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