其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for 3 batches of Baclofen 10mg Tablets (batch number: EBJ25001F01, EBJ25002F01, EBJ25003F01) do not contain the correct safety information.
An updated Summary of Product Characteristics (SPC) is now available in the MHRA website. The safety information missing in the PIL and previous SPC includes:
- PIL Section 2, What you need to know before you take baclofen
- PIL Section 4, Possible side effects
- SPC Section 4.4, Section 4.8 and Section 4.9
For details, please refer to the website in MHRA.
The quality of the tablets is not impacted by this issue; 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 dispensing these products, especially for new patients. If the medicine listed in this notification are dispensed, ensure that patients are aware of the missing information. Please see the updated PIL in the MHRA website.for the correct information
The product is indicated for the relief of spasticity of voluntary muscle resulting from such disorders as: multiple sclerosis, other spinal lesions, e.g. tumours of the spinal cord, syringomyelia, motor neurone disease, transverse myelitis, traumatic partial section of the cord. It is also indicated for the relief of spasticity of voluntary muscle arising from e.g. cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-special-concept-development-uk-limited-baclofen-10mg-tablets-el-25-a-slash-51
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Nov 28, 2025
Issued at HKT 16:45
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