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Be aware of error in Diflucan patient leaflet, MHRA tells pharmacists

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Be aware of error in Diflucan patient leaflet, MHRA tells pharmacists

The Medicines and Healthcare products Regulatory Agency has urged pharmacists and other health professionals to be aware of an error in the patient information leaflet of two batches of Diflucan Oral Suspension 40mg/ml.

The medicines regulator said the drug’s manufacturer Star Pharmaceuticals Limited informed it that section 6 of the leaflet says “50mg of fluconazole per 5ml” instead of “200mg of fluconazole per 5ml” while the other sections of the leaflet and product information state the correct strength of 200mg of fluconazole per 5ml.

The error appears in the leaflets of batches numbered B861104 and B694104.

“Star Pharmaceuticals Limited confirmed they have identified all customers who have been supplied with this product and will initiate direct contact with the relevant customers,” the MHRA said.

It said there was “no risk to product quality” and insisted the batches were not being recalled and patients should continue to take the medicine as prescribed by their doctor “and as per the dispensing label.”

The MHRA also said pharmacists should “continue to use the product as normal but be aware of the typographical error highlighted in this notification.”

Meanwhile, Community Pharmacy Scotland has notified pharmacies in the country about the implementation of two serious shortage protocols – one for Cefalexin 500mg tablets until September 27, 2024 and one for Ramipril 2.5mg tablets until November 15.

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