Class 4 medicines defect information – Caution in Use – distribute to pharmacy level
Ref: EL(12)A/31
Diflucan 10mg/ml powder for oral suspension – PL 00057/0343
Diflucan 40mg/ml powder for oral suspension – PL 00057/0344
(manufactured by Pfizer)
The labels and patient information leaflet (PIL) for Diflucan (fluconazole) 10mg/ml powder for oral suspension and Diflucan (fluconazole) 40mg/ml powder for oral suspension have recently been amended.
Pfizer has informed the Medicines and Healthcare Regulatory Agency (MHRA) that due to these changes, there may be some confusion as follows when reconstituting the product:-
- The PIL that comes with both strengths of product provides reconstitution instructions for a 175ml bottle. The 175ml bottle does not exist in the UK and pharmacists are asked to disregard these instructions. The only pack size available in the UK is the 60ml bottle. The instructions for reconstitution are in the PIL in the section containing information intended for medical or healthcare professionals.
- The level mark on the label (which is referred to in the reconstitution instructions) for Diflucan (fluconazole) 40mg/ml powder for oral suspension, batch number A233306, is missing. Pharmacists are advised to add 24ml of water to the product which produces 35ml of suspension.
Affected stock will continue to be supplied and distributed to ensure there is a continuity of supplies.
It may be several months before the PIL is amended.
For further information, contact Pfizer medical information team on 01304 616161.
