其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: ADVANZ PHARMA, MacroBID 100mg Prolonged-Release Capsules (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that ADVANZ PHARMA has made the MHRA aware that certain batches of MacroBID 100mg Prolonged-Release Capsules (nitrofurantoin) (batch number: 21001, 21002, 21003, 22001, 22002, 22003, 22006, 22007) have been packed with the incorrect Patient Information Leaflet (PIL). The PIL does not contain important safety information relating to Possible Side effects and has minor editorial inconsistencies.
Missing safety information from the PIL:
Section 4. Possible Side effects
- Scarring due to damaged lung tissue may occur
- In rare cases, it may cause liver failure which may be fatal
- Damage to bone marrow causing deficiency of the red blood cells (anaemia)
Please note that the minor editorial inconsistencies have not been listed as they have no impact on the information contained within the PIL. These will be corrected in all future batches of MacroBID 100mg Prolonged-Release Capsules.
Healthcare professionals should note that there is no risk to product quality and efficacy, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the above batches. Please provide a copy of the Summary of Product Characteristics when dispensing this medication to patients.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-advanz-pharma-macrobid-100mg-prolonged-release-capsules-el-22-a-slash-50
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Dec 6, 2022
Issued at HKT 15:00
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