其 他 安 全 警 示
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| Singapore: Imovane (zopiclone) Tablet 7.5mg: restriction of indications (English Only) |
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Health Sciences Authority (HSA) announces that Sanofi-aventis would like to inform healthcare professionals about the new restriction of the indication to “short-term” treatment of insomnia and additional recommendations on the duration of treatment. These risk minimisation measures are intended to promote the proper use of zopiclone and limit the risk of abuse and drug dependence. The Imovane package insert has been updated with the above information.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../imovane-zopiclonetablet75mgrestrictionofindications.html
In Hong Kong, there are 30 registered pharmaceutical products containing zopiclone, and all products are prescription-only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to zopiclone, but these cases are not related to abuse and drug dependence. Recommendation on short-term use of the drug and the risk of dependence are documented in reputable drug references such as Martindale: The Complete Drug Reference. DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Monday, Nov 19, 2018
Issued at HKT 16:00
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