IMOVANE (zopiclone) - New Dosage Recommendations to Minimize
This is duplicated text of a letter from sanofi-aventis Canada Inc. Contact the company for a copy of any references, attachments or enclosures.
If you experience excessive drowsiness the next day after taking IMOVANE that affects your ability to perform tasks in the morning contact your physician as your dose may need to be reduced.
IMOVANE is a prescription medication intended to help you sleep if you have transient and short-term insomnia.
Do not use IMOVANE along with other medications, over-the-counter medicines or herbal products without first discussing this with your doctor or pharmacist. Do not use IMOVANE if you drink alcohol. Do not take more IMOVANE than prescribed. IMOVANE should be taken at bedtime immediay before going to sleep.
Sanofi-aventis Canada Inc., in consultation with Health Canada, would like to inform you of important new dosing instructions related to IMOVANE (zopiclone).
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You can report any suspected side effect associated with the use of health products to Health Canada by:
Franca Mancino, M.Sc. Vice President, Medical and Regulatory Affairs For more information.
Contact the company for a copy of any references, attachments or enclosures. This is duplicated text of a letter from sanofi-aventis Canada Inc.
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For other health product inquiries related to this communication, contact Health Canada at: Marketed Health Products Directorate ephone: Sincerely, original signed by.
This can cause next-day impairment of driving or other activities that require full mental alertness. Patients who take IMOVANE and other medicines to help them sleep may experience decreased ability to be alert the day after taking the medicine, even if they feel fully awake.
operating machinery):. DO NOT drive a car or engage in hazardous activities requiring complete alertness (e.g.
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Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. or Health Canada. Any case of serious next-day impairment or other serious or unexpected side effects in patients receiving IMOVANE should be reported to sanofi-aventis Canada Inc.
Subject: New dosing instructions for IMOVANE (zopiclone) to minimize the risk of next-day impairment.
Notice about Health Canada advisories November 19, 2014.
sanofi-aventis Canada Inc. 2905 Place Louis-R.-Renaud LAVAL, Quebec H7V 0A3 Phone:.