Class 4 Medicines Defect Information: Sevredol 10mg & 20mg tablets

Class 4 Medicines Defect Information: Sevredol 10mg & 20mg tablets

July 12, 2021

Class 4 Medicines Defect Information: Sevredol 10mg and 20mg tablets (PL 16950/0063, PL 16950/0064)

Medicines Notification number: EL (21)A/17

MDR Number: MDR 074-07/21

Date issued: 12 July 2021

The Medicines and Health products Regulatory Agency (MHRA) has issued a Class 4 Medicines Defect Information:

Sevredol 10mg and 20mg tablets (PL 16950/0063, PL 16950/0064)

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.

Sevredol 10mg tablets PL 16590/0063

Batch Number Expiry Date Pack Size First Distributed
243406 29 Feb 2024 56 27 May 2021
244570 29 Feb 2024 56 not yet distributed

Active Pharmaceutical Ingredient: Morphine sulfate

Sevredol 20mg tablets PL 16590/0064

Batch Number Expiry Date Pack Size First Distributed
244573 31 Mar 2024 56 18 June 2021

Active Pharmaceutical Ingredient: Morphine sulfate

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 for 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.

The correct PIL can be found here

Further Information

Full Medicines Notification can be viewed here

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

 



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