Napp Pharmaceuticals has noticed an error in the PIL of specific batches of Sevredol 10 mg Tablets and Sevredol 20 mg Tablets.
The affected batch numbers are 243406 and 244573 respectively.
“Healthcare professionals are advised to exercise caution when dispensing the product and where possible, provide an updated PIL,” the MHRA said, adding that there is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled.
The error identified relates to approved safety-related variations to the PIL that were not implemented, resulting in an older version of artwork being used and packed within finished batches.
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)”
Where available, Napp will be providing the updated PIL with all future deliveries for the affected batches.