The Medicines and Health products Regulatory Agency (MHRA) has issued a class four medicines defect notice for zopiclone tablets.
The defect information notice issued for Zopiclone 3.75mg, 7.5mg tablets of Ratiopharm UK Limited and Zopiclone 3.75mg tablets of Generics UK T/A Mylan.
Both Ratiopharm UK and Generics UK 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.
Missing information from the patient information leaflet include
- 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 include
- 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 EL (20)A/44 Page 2 of 2
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
- Some epidemiological studies show an increased incidence of suicidal ideation, suicide attempt and suicide in patients with or without depression, and treated with benzodiazepines
Healthcare professionals are advised that the patients should be made aware that the information on the possible risk of suicide is missing from the PIL provided in their packs.
When dispensing this product, pharmacists have been asked to check the Marketing Authorisation Holder and if any of the products listed below are being dispensed, they should ensure patients are made aware of the missing information.
