Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Chemidex Pharma Ltd, Ponstan 250mg Capsules & 500mg Tablets (mefenamic acid) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Chemidex pharma ltd has informed the MHRA that the patient information leaflet (PIL) in the cartons for Ponstan 250mg capsules (batch number: 23I114, 23I115, 23I120, 23I121, 23I122) and Ponstan Forte 500mg tablets (batch number: 23J153, 23J155, 23J172) include an out of date PIL, dated March 2020 and January 2021 respectively. The latest PIL, authorised in February 2023 includes updated information related to the use of the product during pregnancy, which is not mentioned in the out of date PILs.
Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing these products. When product from the affected batches are supplied or dispensed, ensure that patients are aware of the missing information.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-chemidex-pharma-ltd-ponstan-250mg-capsules-and-500mg-tablets-mefenamic-acid-el-24-a-slash-40
In Hong Kong, Ponstan Cap 250mg (HK-06133) and Ponstan Film Coated Tab 500mg (HK-08232) are pharmaceutical products registered by Pfizer Corporation Hong Kong Limited (Pfizer). The products are prescription-only medicines. As confirmed by Pfizer, the affected batches have not been imported into Hong Kong.
Ends/Wednesday, Aug 28, 2024
Issued at HKT 16:45
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