Each film-coated tablet contains 200 mg of fidaxomicin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Capsule shaped tablets of 14 mm, white to off-white in colour, debossed with “FDX” on one side and “200” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
DIFICLIR is indicated in adults for the treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) (see section 5.1).
Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
4.2 Posology and method of administration
Posology
Adults and elderly (≥65 years of age)
The recommended dose is 200 mg (one tablet) administered twice daily (once every 12 hours) for 10 days.
Special populations
Renal impairment
No dose adjustment is considered necessary. Due to the limited clinical data in this population, DIFICLIR should be used with caution in patients with severe renal impairment (see sections 4.4 and 5.2).
Hepatic impairment
No dose adjustment is considered necessary. Due to the limited clinical data in this population, DIFICLIR should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Paediatric population
The safety and efficacy of fidaxomicin in children aged below 18 years has not yet been established. No data are available.
Method of administration
DIFICLIR is intended for oral use.
DIFICLIR can be taken with or without food.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Hypersensitivity reactions including severe angioedema have been reported (see section 4.8). If a severe allergic reaction occurs during treatment with DIFICLIR, the medicinal product should be discontinued and appropriate measures taken.
Some patients with hypersensitivity reactions reported a history of allergy to macrolides. Fidaxomicin should be used with caution in patients with a known macrolides allergy.
Due to limited clinical data, fidaxomicin should be used with caution in patients with severe renal impairment or moderate to severe hepatic impairment (see section 5.2).
Due to limited clinical data, fidaxomicin should be used with caution in patients with pseudomembranous colitis, fulminant or life threatening CDI.
Co-administration of potent P-glycoprotein inhibitors such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see sections 4.5 and 5.2).
4.5 Interaction with other medicinal products and other forms of interaction
Effect of P-gp inhibitors on fidaxomicin
Fidaxomicin is a substrate of P-gp. Co-administration of single doses of the P-gp inhibitor cyclosporine A and fidaxomicin in healthy volunteers, resulted in a 4- and 2-fold increase in fidaxomicin Cmax and AUC, respectively and in