Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Atnahs Pharma UK, Zestoretic 20mg/12.5mg Tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Atnahs Pharma UK has informed the MHRA that the Patient Information Leaflet (PIL) packaged in one batch of Zestoretic 20mg/12.5mg Tablets (lisinopril and hydrochlorothiazide) (batch number: SB012) contains outdated safety information.
Healthcare professionals should note that the critical missing information is contained within Section 4 of the incorrect PIL, however it is not in line with the recommended update to the Summary of Product Characteristics (SmPC) and PIL. It omits specific text to alert prescribers and patients to new information that relates to a side effect classified as having a very rare frequency (less than 1 in 10,000). Details of the discrepancies are listed below:
- Section 2: ‘If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Zestoretic, seek medical attention immediately’.
- Section 4: ‘Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion)’.
There is no risk to product quality as a result of this issue. Healthcare professionals are advised to exercise caution when dispensing the above batch of the product. Where possible, please provide an updated copy of the PIL to the patient and remind the patient to read the leaflet in its entirety before using the medicine.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-atnahs-pharma-uk-zestoretic-20mg-slash-12-dot-5mg-tablets-el-23-a-slash-05
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Feb 28, 2023
Issued at HKT 14:30
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