其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Notification: Dulcolax Adult 5 mg Gastro-resistant Tablets, Opella Healthcare UK (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets (pack size 20 count) (bisacodyl) (batch number: 240908, 240909, 241873, 241875, 250222, 250307, 250308). The dose instruction incorrectly states for use in 12 years and older. These packs are for general sale (GSL) and are intended for use only in adult patients (18 years and over). Although the same active ingredient and strength is indicated for children 12 years and over, the alternative licensed product, Dulcolax Twelve Plus tablets (‘P’ pack) should only be used in children 12 years and over after consultation with a pharmacist.
The product is indicated for the short-term relief of occasional constipation.
Opella Healthcare UK LTD have confirmed that the batches of Dulcolax Adult 5mg GR Tablets (pack size 20 count) listed in this notification were distributed to both pharmacy and non-pharmacy retailers. However, following a discussion with the MHRA all further stock of the batches listed in this notification which have been partially distributed and those batches not yet distributed will only be provided to pharmacy stores, and several healthcare stores. Opella Healthcare UK LTD will contact the customers directly to make them aware of this issue and further supply and these batches will be distributed from 10 June 2025. Batches which are repacked into amended artwork cartons where possible, will be made available to all retailers.
Healthcare professionals and retailers are advised to review the information contained within this notification and where possible, customers should be informed that Dulcolax Adult 5mg GR Tablets is approved for adult use only and to take the product as indicated in the Patient Information Leaflet (PIL) or based on advice from their healthcare professional.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-dulcolax-adult-5-mg-gastro-resistant-tablets-opella-healthcare-uk-el-25-a-slash-26
In Hong Kong, Dulcolax Adult 5mg Gastro-resistant Tablets (pack size 20 count) is not a registered pharmaceutical product.
Ends/Wednesday, Jun 11, 2025
Issued at HKT 17:30
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