其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Notification: Rabeprazole sodium 10mg and 20mg gastro-resistant tablets (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in Rabeprazole sodium 10 mg gastro-resistant tablets (batch number: LC72047, LC74744, LC76888) and Rabeprazole sodium 20 mg gastro-resistant tablets (batch number: LC72045, LC75526, LC76906) do not contain the most up to date safety information. For details of the affected sections of the PIL, please refer to the website in MHRA.
The products are indicated for the treatment of active duodenal ulcer, active benign gastric ulcer, symptomatic erosive or ulcerative gastro-oesophageal reflux disease, gastro-oesophageal reflux disease long-term management, symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.
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. Provide a copy of the updated PIL which can be accessed in the website in MHRA and remind the patient to read the entire leaflet before taking the medicine.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-notification-rabeprazole-sodium-10mg-and-20mg-gastro-resistant-tablets-el-25-a-slash-01
In Hong Kong, Razole Gastro-resistant Tablets 10mg (HK-66163) and Razole Gastro-resistant Tablets 20mg (HK-66164) are pharmaceutical products registered by Jacobson Medical (Hong Kong) Ltd (Jacobson). The products are prescription-only medicines. As confirmed by Jacobson, the affected batches have not been imported into Hong Kong.
Ends/Friday, Jan 10, 2025
Issued at HKT 15:00
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