IMOVANE (zopiclone) - New Dosage Recommendations to Minimize the Risk of Next-Day Impairment - For the Public

Starting date:
November 19, 2014
Posting date:
November 19, 2014
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-42255

This is duplicated text of a letter from sanofi-aventis Canada Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on IMOVANE (zopiclone)

November 19, 2014

Subject: New dosing instructions for IMOVANE® (zopiclone) to minimize the risk of next-day impairment

Sanofi-aventis Canada Inc., in consultation with Health Canada, would like to inform you of important new dosing instructions related to IMOVANE® (zopiclone).

IMOVANE is a prescription medication intended to help you sleep if you have transient and short-term insomnia.

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. This can cause next-day impairment of driving or other activities that require full mental alertness.

  • The recommended initial dose has been reduced to 3.75 mg (one-half of the 7.5 mg tablet). Elderly patients, those with liver or kidney function impairment or those currently taking other specific medication should not take more than 5 mg daily.
  • If you are concerned about your current dosage, contact your healthcare professional.

DO NOT drive a car or engage in hazardous activities requiring complete alertness (e.g. operating machinery):

  • If it has not been at least 12 hours since taking the medicine, even if you feel fully awake, especially in elderly patients and in patients who take the 7.5 mg dose, and
  • In all cases, until you experience how this medication affects you on the next day.

IMOVANE should be taken at bedtime immediately before going to sleep. Do not take more IMOVANE than prescribed. Do not use IMOVANE if you drink alcohol. Do not use IMOVANE along with other medications, over-the-counter medicines or herbal products without first discussing this with your doctor or pharmacist.

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.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. 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. or Health Canada.

sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
LAVAL, Quebec
H7V 0A3
Phone: 1-800-265-7927

You can report any suspected side effect associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
     
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Sincerely,

original signed by

Franca Mancino, M.Sc.
Vice President, Medical and Regulatory Affairs