Revised SPC: Dificlir (fidaxomicin) 200 mg film-coated tablets

The therapeutic indication has been amended to include paediatric patients with a body weight ≥12.5 kg, and data on paediatric patients has been added to other sections of the SPC. Other additions include a caution on concomitant use with P-glycoprotein inhibitors.

SPS commentary:

A reference to Dificlir granules has been added for adult patients with swallowing difficulties; this new formulation is however not yet available. The SPC also now notes that the film-coated tablets should be swallowed whole with water.


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