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Sevredol PIL alert

Missing safety information; batches not being recalled

July 16th 2021

Tagged: MHRA alert

By MHRA

Napp Pharmaceuticals has advised of an error affecting the Patient Information Leaflet of specific batches of Sevredol 10mg and 20mg tablets.

Affected batches do not include the new version PIL which contains the following additions:

  • 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.  Batches are not being recalled