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Subject: New dosing instructions to minimize risk of next-day impairment after use of Sublinox (zolpidem tartrate) in women and men.
Follow your doctor’s advice on how to take Sublinox, when to take it, and how long to take it. As with all hypnotics, long term use of Sublinox is not recommended, and the lowest effective dose should be used in consultation with your doctor. Sublinox should be taken right before going into bed. Do not take Sublinox in the middle of the night or at any time other than at bedtime.
Sublinox is a medicine used in adults as a sleep aid. The new dosing instructions are as follows:
Valeant Canada 2150 St-Élzear Blvd. West, Laval Québec, H7L 4A8.
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For other health product inquiries related to this communication, please contact Health Canada at: Marketed Health Products Directorate ephone:
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The recommended dose for elderly patients (65 years of age or older) is 5 mg, regardless of gender.
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Dr. Maxime Barakat Executive Director, Medical and Regulatory Affairs Valeant Canada LP.
MEDA VALEANT PHARMA CANADA INC., in consultation with Health Canada, would like to inform you of important new dosing instructions related to Sublinox (zolpidem tartrate).
If you would like more information you can call the medical information line at. Sincerely, original signed by.
The information provided will help you in making the right decision in consultation with your health care professional.
Notice about Health Canada advisories January 3, 2014.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Any case of serious or unexpected adverse reactions in patients receiving Sublinox should be reported to Valeant Canada or Health Canada.
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You should not drive a car or engage in hazardous activities requiring complete alertness until you experience how the drug affects you the next day.
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Discuss any questions or concerns you may have about Sublinox with your healthcare professional.
This is duplicated text of a letter from Valeant Canada. Contact the company for a copy of any references, attachments or enclosures.