其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Sandoz Ltd., Risperidone 1mg, 2mg, 3mg Tablets (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for the following products:
- Risperidone 1mg Tablets (batch number: NK4910, NK4909)
- Risperidone 2mg Tablets (batch number: NL4679)
- Risperidone 3mg Tablets (batch number: MM5115, NE5508)
The PIL and SmPC does not include the Adverse event of Stevens Johnson’s syndrome and toxic epidermal necrolysis in section 4.8 Adverse drug reactions for the MedDRA System Organ Class ‘Skin and subcutaneous tissue disorders’.
There is no risk to product quality or impact to safety of the medicines listed in this notification because of this missing information. Healthcare professionals are advised to review the content of this notification, as it provides information that is missing from the current label and take this into account when prescribing. If the medicines listed in this notification are supplied or dispensed, ensure that patients are aware of the missing information. It is important to advise patients that if patients experience any of the above symptoms they should seek immediate medical advice.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sandoz-ltd-dot-risperidone-1mg-2mg-3mg-tablets-el-24-a-slash-43
In Hong Kong, Risperidone Sandoz Tab 1mg (HK-59970), Risperidone Sandoz Tab 2mg (HK-59969) and Risperidone Sandoz Tab 3mg (HK-59972) are pharmaceutical products registered by Sandoz Hong Kong Limited (Sandoz). The products are prescription-only medicines. As confirmed by Sandoz, the affected batches have not been imported into Hong Kong.
Ends/Friday, Sep 27, 2024
Issued at HKT 16:30
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