其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Slenyto 1mg and 5mg prolonged-release tablets – distributed by Flynn Pharma Ltd (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that there is an error with the patient information leaflets (PILs) that have been packaged in the following batches of Slenyto 1mg and 5mg prolonged-release tablets (melatonin). The affected products are:
- Slenyto 1mg prolonged-release tablets (batch number: 1049309A, 1049310, 1049311, 1049312, 1051815, 80419B, 90287, 10175A, 10186)
- Slenyto 5mg prolonged-release tablets (batch number: 00130, 00409C, 10058)
These were an older version of the PIL which did not include the most up to date safety information. The information missing from the PILs is as below:
- Section 2 Other medicines and Slenyto: This should include “- beta-blockers (used to control blood pressure). These medicines should be taken in the morning.”
- Section 6 Contents of the pack and other information: In the section “What Slenyto looks like and contents of the pack”, the number “30 / ” is missing from the approved wording for the 1 mg tablet pack size and should state “Available in blister packs of 30 / 60 tablets.”
There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the product and where possible, provide an updated PIL.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-slenyto-1-mg-and-5mg-prolonged-release-tablets-distributed-by-flynn-pharma-ltd-el-21-a-slash-29
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Tuesday, Nov 16, 2021
Issued at HKT 15:00
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