Class 4

Class 4 Medicines Defect Information, Sevredol 10 mg and 20mg tablets, (PL 16950/0063, PL 16950/0064), EL (21)A/17

Napp Pharmaceuticals Limited have noticed and an error in the PIL of specific batches of Sevredol 10 mg Tablets and Sevredol 20 mg Tablets.

MDR Number

MDR 074-07/21

Company name

Napp Pharmaceuticals Limited

Product description

Sevredol 10 mg tablets PL 16950/0063

Details of the affected batches:

Batch number

Expiry date

Pack size

First distributed

243406

28 Feb 2024

56

27 May 2021

244570

29 Feb 2024

56

not yet distributed

Sevredol 20 mg tablets PL 16950/0064

Details of the affected batch:

Batch number

Expiry date

Pack size

First distributed

244573

31 March 2024

56

18 June 2021

Brief description of problem

Napp Pharmaceuticals Limited would like to notify you of an error regarding specific batches of Sevredol 10 mg Tablets and Sevredol 20 mg Tablets, sold and distributed in the UK. 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)”

Advice to Healthcare Professionals

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. Where available, Napp will be providing the updated PIL with all future deliveries for the affected batches.

Please see link to updated PIL available from the MHRA.

Company contacts for further information

For more information, medical information queries or replacement PIL enquiries, please contact: medicalinformationuk@napp.co.uk
For stock control queries, please contact:supplies.uk@napp.co.uk

To access the full recall:
Class 4 Medicines Defect Information, Sevredol 10 mg and 20mg tablets, (PL 16950/0063, PL 16950/0064), EL (21)A/17