其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information, Tetralysal 300mg Hard Capsules (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Galderma UK identified an error regarding specific batches of Tetralysal (lymecycline) 300mg Hard Capsules (batch number: 853, 869, 881) sold and distributed in the United Kingdom. The error identified relates to approved safety-related variations to the Patient Information Leaflet (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)
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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-tetralysal-300mg-hard-capsules-pl-10590-slash-0019-el-21-a-slash-16
In Hong Kong, Tetralysal Cap 300mg (HK-06231) is registered by Galderma Hong Kong Limited (Galderma), and is a prescription-only medicine. As confirmed with Galderma, the affected batches have not been imported into Hong Kong.
Ends/Wednesday, Jul 7, 2021
Issued at HKT 14:00
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