Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets,  EL(25)A/51
Source: gov.uk (2025-11-27)

Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information.

DMRC reference number

DMRC - 37308281

Marketing Authorisation Holder

Special Concept Development UK Limited trading as RxFarma

Medicine Details

Baclofen 10mg Tablets

PL: 36722/0105

Active ingredient: baclofen

SNOMED code: 40692211000001105

GTIN: xx-xxxx-xxxx

Affected Lot Batch Numbers

Background

Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches in the table do not contain the correct safety information.

An updated Summary of Product Characteristics (https://mhraproducts4853.blob.core.windows.net/docs/b1cf242769a0575c94ac727bf0106d2cb42c77a5) (SPC) is now available. The safety information missing in the PIL and previous SPC is summarised below:

Advice for Healthcare Professionals:

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 (https://mhraproducts4853.blob.core.windows.net/docs/72aba8d69439c8ef5cf17181fd1a0185f14edd1f) for the correct information.

Upon request, Special Concept Development UK Limited will provide hard copies of the PIL to pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact xxx@xxx.xx (mailto:xxx@xxx.xx) with your details, i.e. address, product with batch details, required number of leaflets.

Special Concept Development UK Limited has confirmed that all future batches will contain the correct PIL.

Advice for Patients:

This issue is about missing information on the Patient Information Leaflets (PILs) in the batches of Baclofen 10mg tablets included in the table. The quality of the tablets is not affected.

If you have concerns about the medicine you are using, please contact your healthcare professional in the first instance.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme (https://yellowcard.mhra.gov.uk/).

Additional information:

For medical information enquiries please email xxx@xxx.xx (mailto:xxx@xxx.xx) or telephone xx-xxxx-xxxx.

For supply chain inquiries please contact email xxx@xxx.xx (mailto:xxx@xxx.xx) or telephone xx-xxxx-xxxx.

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Defective Medicines Report Centre10 South ColonnadeCanary WharfLondonE14 4PU

Telephone xx-xxxx-xxxx

xxx@xxx.xx (mailto:xxx@xxx.xx)

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Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51 (https://assets.publishing.service.gov.uk/media/692840f02a37784b16ecf636/Class_4_Medicines_Defect_Notification_-_Special_Concept_Development_UK_Limited__Baclofen_10mg_Tablets___EL25_A51.pdf)