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Public Alert No. 0038/2020 – Safety labelling change – Fluconazole (Flunoc) PIL Update

December 18, 2020,

The National Agency for Food and Drug Administration and Control has been informed by Novartis Nigeria about the update to the Patient Information Leaflet (PIL) of fluconazole following internal review of available safety information according to the company’s core data sheet update.  

Changes were made to the Other medicines and Flunoc section; Ibrutinib (used to treat some cancers of the blood) was added to the list of medicines that may interact with Flunoc

Recommendations

  • Patients and Consumers are encouraged to always read the PIL of the medicines they are taking. They are also encouraged to tell their healthcare provider of all other medicines they are taking when they are being given prescriptions.
  • Healthcare providers are encouraged to apply caution in concomitant prescription of medicines with known interactions.

Healthcare providers and patients are encouraged to report adverse events experienced with the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks),  via pharmacovigilance@nafdac.gov.ng, E- reporting platforms available on the NAFDAC website or via the Med- safety application available for download on android and IOS stores.

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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