Class 4 Medicines Defect Information:
MacroBID 100mg Prolonged-Release Capsules (ADVANZ PHARMA)
Drug alert number: EL (22)A/50
Date issued: 05 December 2022
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:
MacroBID 100mg Prolonged-Release Capsules, PL 12762/0052
Active Pharmaceutical Ingredient: Nitrofurantoin
Brief description of the problem
ADVANZ PHARMA has made the MHRA aware that the above batches of MacroBID 100mg Prolonged-Release Capsules 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, 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.
Advice for healthcare professionals
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 (SmPC) when dispensing this medication to patients.
ADVANZ PHARMA has confirmed that all future batches will contain the correct PIL. Upon request, ADVANZ PHARMA will post hard copies of the updated PIL and/or SmPC to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information.
Advice for patients
Patients should be aware that some packs of MacroBID 100mg Prolonged-Release Capsules may contain the incorrect Patient Information Leaflet (PIL). The incorrect PIL does not contain important safety information relating to Possible Side effects.
If you have any questions about your medicine or are concerned about side effects, talk to your healthcare professional. The medicine itself is not affected and any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.
View full alert here
For further information, medical enquiries, stock information or request for printed copy of the associated SmPC, please contact telephone: + 44 (0) 208 5889 131 or via email: email@example.com.
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