MHRA Class 4 Medicines Defect Information: Tetralysal 300mg Hard Capsules (PL 10590/0019)

Class 4 Medicines Defect Information: Tetralysal 300mg Hard Capsules (PL 10590/0019)

Medicines Notification number: EL (21)A/16

MDR Number: MDR 387-06/21

Date issued: 06 July 2021

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

Tetralysal 300mg Hard Capsules (PL 10590/0019)

Galderma UK would like to notify you of an error identified by Galderma regarding specific batches of Tetralysal 300mg Hard Capsules (listed below), 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.

Tetralysal 300mg Hard Capsules PL 10590/0019

Active Pharmaceutical Ingredient: Lymecycline

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 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, 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

Further Information

Full Medicines Notification can be viewed here

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