Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Sandoz Limited, Omeprazole products |
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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 and Summary of Product Characteristics (SmPCs) of the following omeprazole products. The affected products are:
- Omeprazole 10mg gastro-resistant capsules
- Omeprazole 20mg gastro-resistant capsules
- Mezzopram 10mg dispersible gastro-resistant tablets
- Mezzopram 20mg dispersible gastro-resistant tablets
- Mezzopram 40mg dispersible gastro-resistant tablets
- Omeprazole 40mg powder for solution for infusion vials
For details of the affected batch numbers, please refer to the website in MHRA.
The product information does not include a warning/precaution for severe cutaneous adverse reactions (SCAR) in section 4.4, and adverse events of drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) in section 4.8 of the SmPC.
There is no risk to product quality or safety of the medicines because of this missing information. Therefore the affected batches are not being recalled.
Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing. If any of the above products are supplied and/or dispensed, ensure that patients are aware of the missing information as highlighted above.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sandoz-limited-omeprazole-products-el-24-a-slash-34
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Aug 8, 2024
Issued at HKT 16:00
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