Class 4 Medicines Notification: Rabeprazole sodium 10mg and 20mg gastro-resistant tablets, EL(25)A/01
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: DMRC 33946703
Company name: Bristol Laboratories Limited
Product descriptions:
Rabeprazole sodium 10mg gastro-resistant tablets, PLGB 17907/0457 SNOMED Code 36601411000001106
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| LC72047 | 10/2025 | 28 | 4 September 2023 |
| LC74744 | 02/2026 | 28 | 18 October 2023 |
| LC76888 | 05/2026 | 28 | 30 September 2024 |
Rabeprazole sodium 20mg gastro-resistant tablets, PLGB 17907/0458 SNOMED Code 36601611000001109
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| LC72045 | 12/2025 | 28 | 8 March 2023 |
| LC75526 | 05/2026 | 28 | 24 August 2023 |
| LC76906 | 08/2026 | 28 | 30 September 2024 |
Brief description of problem:
Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the above specified batches of Rabeprazole sodium 10mg gastro-resistant tablets and Rabeprazole sodium 20mg gastro-resistant tablets do not contain the most up to date safety information. The affected sections of the PIL are summarised in the table below:
| Section 2 | What you need to know before you take Rabeprazole Sodium | Do not take Rabeprazole Sodium |
| Section 2 | What you need to know before you take Rabeprazole Sodium | Warnings & Precautions |
| Section 2 | What you need to know before you take Rabeprazole Sodium | Children |
| Section 2 | What you need to know before you take Rabeprazole Sodium | Other medicines and Rabeprazole Sodium |
| Section 2 | What you need to know before you take Rabeprazole Sodium | Pregnancy and breastfeeding |
| Section 2 | What you need to know before you take Rabeprazole Sodium | Driving and using machines |
| Section 3 | How to take Rabeprazole sodium | Taking the Medicines |
| Section 3 | How to take Rabeprazole sodium | If you forget to take Rabeprazole sodium |
| Section 4 | Possible Side Effects | Stop taking this medicine |
| Section 4 | Possible Side Effects | Other possible side effects Common (affect less than 1 in 1000) |
| Section 4 | Possible Side Effects | Other possible side effects (affect less than 1 in 100 people) |
| Section 4 | Possible Side Effects | Other possible side effects Rare (may affect up to 1 in 1000 people) |
| Section 4 | Possible Side Effects | Other possible side effects (unknown frequency) |
| Section 4 | Possible Side Effects | Reporting of side effects |
Advice to 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
Rabeprazole sodium 20mg gastro-resistant Tablets
Advice to 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
Rabeprazole sodium 20mg gastro-resistant Tablets
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.
Company contacts for further information:
For medical information enquiries please contact at: email: info@bristol-labs.co.uk, or telephone: +44 (0) 1442 200 922
For stock control enquiries please contact at email: notifications@bristol-labs.co.uk, or telephone: +44 (0) 1442 200 922
To access the full recall: Class 4 Medicines Notification: Rabeprazole sodium 10mg and 20mg gastro-resistant tablets, EL(25)A/01