FIDAXOMICIN

1). FIDAXOMICIN 40 mg/ml granules for oral suspension may be used in adult patients with difficulties in swallowing tablets. 1). If a dose has been forgotten, the missed dose should be taken as soon as possible or, if it's nearly time for the next dose, the tablet should be skipped altogether.

2). Renal impairment No dose adjustment is considered necessary. 2). Hepatic impairment No dose adjustment is considered necessary. 2). 5 kg is 200 mg administered twice daily (once every 12 hours) for 10 days using the film-coated tablets or the granules for oral suspension.

5 kg. See the SmPC of FIDAXOMICIN 40 mg/ml granules for oral suspension. Method of administration FIDAXOMICIN is intended for oral use. The film-coated tablets should be administered whole with water. They can be taken with or without food.

2%). Tabulated list of adverse reactions Table 1 displays adverse reactions associated with twice daily administration of fidaxomicin in the treatment of C. difficile infection, reported in at least two patients, presented by system organ class.

The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 4). Paediatric population The safety and efficacy of fidaxomicin has been evaluated in 136 patients from birth to less than 18 years of age.

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults. In addition to the ADRs shown in table 1, two cases of urticaria were reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

8). If a severe allergic reaction occurs during treatment with fidaxomicin, 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. 2). Pseudomembranous colitis, fulminant or life threatening CDI Due to limited clinical data, fidaxomicin should be used with caution in patients with pseudomembranous colitis, fulminant or life threatening CDI.

2). In case fidaxomicin is administered concomitantly with potent P-glycoprotein inhibitors, caution is advised. Paediatric population Only one paediatric patient below 6 months of age has been exposed to fidaxomicin in clinical trials.

Therefore, patients below 6 months of age should be treated with caution. Testing for C. difficile colonization or toxin is not recommended in children younger than 1 year due to high rate of asymptomatic colonisation unless severe diarrhoea is present in infants with risk factors for stasis such as Hirschsprung disease, operated anal atresia or other severe motility disorders.

Alternative aetiologies should always be sought and C. difficile enterocolitis be proven.

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