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

Published On:

15 July 2021

Published In:

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

PL Number(s)

PL 16950/0063, PL 16950/0064

MDR Number

MDR 074-07/21

Company Name

Napp Pharmaceuticals Limited

Product description

Sevredol 10 mg tablets

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

Batch number Expiry date Pack size First distributed
244573 31 March 2024 56 18 June 2021

Active Pharmaceutical Ingredient: Morphine Sulfate

Brief description of the 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 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.

Further Information

For more information, medical information queries or replacement PIL enquiries, please contact: [email protected]

For stock control queries, please contact:[email protected]

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice.

NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information

To read the full article and download the document please click HERE

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