其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information, Sevredol 10 mg and 20mg tablets (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Napp Pharmaceuticals Limited has identified an error regarding specific batches of Sevredol 10 mg tablets and Sevredol 20 mg tablets (morphine sulfate) sold and distributed in the United Kingdom. The error identified relates to approved safety-related variations to the Patient Information Leaflet (PIL) that were not implemented, resulting in an older version of artwork being used and packed within finished batches. The affected products are:
- Sevredol 10 mg tablets (batch number: 243406, 244570)
- Sevredol 20 mg tablets (batch number: 244573)
Below are listed the differences in the PIL text:
- Section 2. What you need to know before taking Sevredol tablets – the addition of “severe asthma”
- Section 2. Warnings and Precautions – the addition of “constipation”.
- Section 2. Warnings and Precautions – the addition of “This medicine may cause breathing problems or worsen already existing problems while sleeping. These problems may include pauses in breathing during sleep, being awoken by shortness of breath, difficulty staying asleep or excessive daytime drowsiness. If you or someone else observes these symptoms contact your doctor. Your doctor may want to lower your dose.”
- Section 2. Other medicines and Sevredol tablets – re-wording of an existing paragraph (no change in the overall meaning)
- Section 4. Possible side effects – the addition of “Problems with breathing during sleep (sleep apnoea syndrome)”
Healthcare professionals are advised to exercise caution when dispensing the product and where possible, provide an updated PIL. There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sevredol-10-mg-and-20mg-tablets-pl-16950-slash-0063-pl-16950-slash-0064-el-21-a-slash-17
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Tuesday, Jul 13, 2021
Issued at HKT 14:00
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