10.09.2020

Zopiclone Tablets - Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan

Threat

Brief description of the problem: Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan have confirmed that the Patient Information Leaflet (PIL) within all packs and the Summary of Product Characteristics (SmPC) for Ratiopharm is missing important safety information related to potential suicide risks.

Find out more

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Source of the alert

MHRA

The risk concerns products
Ratiopharm UK Limited:
  • Zopiclone 3.75 mg Tablets: PL 15773/0028
  • Zopiclone 7.5 mg Tablets: PL 15773/0029
Generics [UK] Limited t/a Mylan
  • Zopiclone 3.75 mg Tablets: PL 04569/0450


Recommendations for consumers
Missing information from the Patient Information Leaflet
  • Some studies have shown an increased risk of suicidal ideation, suicide attempt and suicide in patients taking certain sedatives and hypnotics, including this medicine.
  • However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice.
Missing information from the Summary of Product Characteristics
  • Some epidemiological studies show an increased incidence of suicidal ideation, suicide attempt and suicide in patients with or without depression, and treated with benzodiazepines and other hypnotics, including zopiclone. However, a causal relationship has not been established.
  • As with other hypnotics, zopiclone does not constitute a treatment for depression and may even mask its symptoms (suicide may be precipitated in such patients).
  • Zopiclone should be administered with caution in patients exhibiting symptoms of depression. Suicidal tendencies may be present therefore the least amount of zopiclone that is feasible should be supplied to these patients to avoid the possibility of intentional overdosage by the patient. Pre-existing depression may be unmasked during use of zopiclone. Since insomnia may be a symptom of depression, the patient should be r
Alert details

Country for notification

United Kingdom

Category

Pharmaceuticals

Country of origin

-

Source of the alert

MHRA - Medicines & Healthcare products Regulatory Agency, www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

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