其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Dawa Limited, Trazodone Hydrochloride 50mg, 100mg Capsules & 50mg/5ml Oral Solution (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Dawa Limited has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the following products:
- Trazodone Hydrochloride 50mg Capsules (batch number: 220191, 220192, 220193, 220212, 220340, 220382, 230259)
- Trazodone Hydrochloride 100mg Capsules (batch number: 200284, 200285, 220194, 220213, 220214, 220215, 220237, 220300, 220341, 220383, 230260)
- Trazodone Hydrochloride 50mg/5ml Oral Solution (batch number: C31037, C31038)
The PIL does not contain the latest safety information relating to serotonergic products (trazodone) and the interaction with buprenorphine. For details of the missing information, please refer to the website in MHRA.
There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL. If it is not possible to provide an updated PIL, please advise patients of the missing information, discuss if this medicine is still suitable for them, and the need to seek medical advice if signs or symptoms occur.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-dawa-limited-trazodone-hydrochloride-50mg-100mg-capsules-and-50mg-slash-5ml-oral-solution-el-24-a-slash-37
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Aug 15, 2024
Issued at HKT 15:30
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