MHRA Class 4 Medicines Defect Notification: Rabeprazole sodium 10mg and 20mg gastro-resistant tablets (Bristol Laboratories Limited)

Drug alert number: EL (25)A/01

Date issued: 09 January 2025

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Rabeprazole sodium 10mg and 20mg gastro-resistant tablets (Bristol Laboratories Limited)

DMRC reference number: DMRC-33946703

Company name: Bristol Laboratories Limited

Product name: Rabeprazole sodium 10mg gastro-resistant tablets PL 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

Product name: Rabeprazole sodium 20mg gastro-resistant tablets PL 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

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:.

Section
Content
Description

Section 2
What you need to know before you take Rabeprazole Sodium

Do not take Rabeprazole Sodium
Warnings & Precautions
Children
Other medicines and Rabeprazole Sodium
Pregnancy and breastfeeding
Driving and using machines

Section 3
How to take Rabeprazole sodium

Taking the Medicines
If you forget to take Rabeprazole sodium

Section 4
Possible Side Effects

Stop taking this medicine
Other possible side effects Common (affect less than 1 in 1000)
Other possible side effects (affect less than 1 in 100 people)
Other possible side effects Rare (may affect up to 1 in 1000 people)
Other possible side effects (unknown frequency)
Reporting of side effects

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

Rabeprazole sodium 20mg gastro-resistant Tablets

View full alert here.

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

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.

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

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