其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Morningside Healthcare Limited, Hyoscine Butylbromide 20 mg Film-coated Tablets (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Morningside Healthcare Limited has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged in batch 22237001 of Hyoscine Butylbromide 20 mg Film-coated Tablets. Some packs within the batch may contain a PIL for Midodrine Hydrochloride 2.5 mg & 5 mg Tablets. The issue was identified due to a market complaint, which noted that a Midodrine Hydrochloride 2.5 mg & 5 mg Tablets leaflet had been found in a pack of Hyoscine Butylbromide 20 mg Film-coated Tablets, batch 22237001.
Healthcare professionals should note that there is no risk to product quality and efficacy, therefore the affected batch is not being recalled. Healthcare professionals are advised to exercise caution when dispensing the above batch and to check the PIL. If the pack contains the wrong PIL, it should be removed and destroyed and a copy of the correct PIL provided to the patient. Additionally, any patients who may present with the incorrect leaflet should be provided with a correct leaflet.
Morningside Healthcare Limited has confirmed that all remaining packs of the above batch will not be distributed and that all future batches will contain the updated PIL. Morningside Healthcare Limited has also confirmed that the tablets in the pack of Hyoscine Butylbromide 20 mg Film-coated Tablets remain correct and contain hyoscine butylbromide. This issue only impacts the printed PIL included in the pack.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-morningside-healthcare-limited-hyoscine-butylbromide-20-mg-film-coated-tablets-el-22-a-slash-48
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Nov 22, 2022
Issued at HKT 15:00
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