Class 4

Class 4 Medicines Defect Information, Tetralysal 300mg Hard Capsules, (PL 10590/0019), EL (21)A/16

Galderma UK identified an error regarding an older version of artwork being used and packed with specific batches of Tetralysal 300mg Hard Capsules.

MDR Number MDR 387-06/21

Company name Galderma UK

Product description Tetralysal 300mg Hard Capsules PL 10590/0019

Details of affected batches

Batch number

Expiry date

Pack size

First distributed

853

07-2023

56

17 Feb 2021

869

12-2023

56

21 May 2021

881

03-2024

28

26 May 2021

Brief description of problem

Galderma UK would like to notify you of an error identified by Galderma regarding specific batches of Tetralysal 300mg Hard Capsules, 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. Additional warnings, precautions and side effects have been updated in the latest version of the PIL.

Missing information from the PIL

Other medicines and Tetralysal

  • You should tell your doctor if you are taking any treatment with lithium, this medicine may increase the lithium levels.

Other medicines and Tetralysal

  • Avoid use with penicillins (and other types of antibiotics),

Possible side effects:

  • disturbances of eyesight*
    • *the presence of symptoms, such as visual disturbances, or headaches, could be attributed to increased pressure in the brain (intracranial hypertension). You should stop taking Tetralysal if there is any evidence of pressure increase in the brain. Benign intracranial hypertension, symptoms of which may include headache, vomiting, visual disturbances (blurred vision, blind spots or double vision), or permanent visual loss have been reported with tetracycline therapy.

Possible side effects:

  • depression
  • nightmare
  • The following side effects may occur during treatment with the class of medicines to which Tetralysal belongs (the tetracyclines):
    • systemic lupus erythematosus (an allergic condition that causes joint pain, skin rashes or fever)

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, Galderma UK will be providing the updated PIL with all future deliveries for the affected batches.

The correct PIL is available from the electronic medicines compendium (EMC) website by clicking on the link below:

PIL for Tetralysal 300mg Hard Capsules

Company contacts for further information

For more information, medical information queries or replacement PIL enquiries, please contact: medinfo.uk@galderma.com

For stock control queries, please contact: sales.uk@galderma.com

To access the full recall: Class 4 Medicines Defect Information, Tetralysal 300mg Hard Capsules, (PL 10590/0019), EL (21)A/16