Class 4 Medicines Notification: Rabeprazole sodium 10mg and 20mg gastro-resistant tablets, EL(25)A/01
Source: gov.uk (2025-01-09)

Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the batches in the table for Rabeprazole sodium 10mg and 20mg gastro-resistant tablets do not contain the most up to date safety information.

DMRC reference number

DMRC 33946703

Company name

Bristol Laboratories Limited

Rabeprazole sodium 10mg gastro-resistant tablets, PLGB 17907/0457

SNOMED Code

36601411000001106

Active Pharmaceutical Ingredient: rabeprazole sodium

Rabeprazole sodium 20mg gastro-resistant tablets, PLGB 17907/0458

SNOMED Code

36601611000001109

Active Pharmaceutical Ingredient: rabeprazole sodium

Brief description of the problem

Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the above specified batches of Rabeprazole sodium 10 mg gastro-resistant tablets and Rabeprazole sodium 20 mg gastro-resistant tablets do not contain the most up to date safety information. The affected sections of the PIL are summarized in the table below:

Advice for healthcare professionals

The quality of medicine has not been affected, therefore, the affected batches are not being recalled.

Healthcare professionals are advised to ensure that the patients are aware of the updated safety information when dispensing the affected batches of product. Please provide a copy of the updated PIL and remind the patient to read the entire leaflet before taking the medicine. The electronic version of the PIL is up to date and can be accessed via the following links:

Rabeprazole sodium 10mg gastro-resistant tablets (https://mhraproducts4853.blob.core.windows.net/docs/7461ff7bf90349cf1f26c3bead3b723461eb1298)

Rabeprazole sodium 20mg gastro-resistant Tablets (https://mhraproducts4853.blob.core.windows.net/docs/107dab5a7bbae6cd91a6ce3997bfac76dafb40a7)

Advice for patients

The quality of medicine has not been affected, therefore patients do not need to take any action. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients should be aware that the Patient Information Leaflet (PIL) included in the packs of the above specified batches of medicines does not contain the most up to date safety information. The affected sections of the PIL are included in the table under ‘Brief description of the problem’. The up-to-date version of the Patient Information Leaflet can be accessed via the links below. Please read this before taking the medicine.

Rabeprazole sodium 10mg gastro-resistant tablets (https://mhraproducts4853.blob.core.windows.net/docs/7461ff7bf90349cf1f26c3bead3b723461eb1298)

Rabeprazole sodium 20mg gastro-resistant Tablets (https://mhraproducts4853.blob.core.windows.net/docs/107dab5a7bbae6cd91a6ce3997bfac76dafb40a7)

If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. If you have concerns about a medicine, you may be using, please contact your healthcare professional.

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

Further information

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

For stock control enquiries please contact at email: xxx@xxx.xx (mailto:xxx@xxx.xx), or telephone: xx-xxxx-xxxx

Recipients of this Medicines Recall 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)

Download document

Class 4 Medicines Notification: Rabeprazole sodium 10mg and 20mg gastro-resistant tablets, EL(25)A/01 (https://assets.publishing.service.gov.uk/media/677fae01d721a08c006655e6/EL25A01_Bristol_Labs_rabeprazole_tablets1.pdf)