其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Zopiclone Tablets, Ratiopharm UK Limited and Generics [UK] Limited t／a Mylan (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that 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. The affected products are:
- Ratiopharm UK Limited: Zopiclone 3.75 mg Tablets and Zopiclone 7.5 mg Tablets
- Generics [UK] Limited t/a Mylan: Zopiclone 3.75 mg Tablets
Missing information from the Patient Information Leaflet:
Suicidal ideation/suicide attempt/suicide and depression:
- 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:
Suicidal ideation/suicide attempt/suicide and depression:
- 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 re-evaluated if insomnia persists.
- Any underlying cause of the insomnia should also be addressed before symptomatic treatment to avoid under treating potentially serious effects of depression
It is important that any patients are provided with information on warnings and precautions whilst taking zopiclone products. Additionally, patients who notice the symptoms/side effects or mood effects should seek immediate medical advice.
Healthcare professionals are advised that if any of the affected products are being dispensed, ensure that patients are aware of the missing information by providing guidance in relation to the risk identified and by providing a copy of this alert.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-zopiclone-tablets-ratiopharm-uk-limited-and-generics-uk-limited-t-a-mylan-el-20-a-44
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Sep 11, 2020
Issued at HKT 16:00
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