Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Tillotts Pharma GmbH, Warmbacher Strasse 80, 79618 Rheinfelden, Germany
DIFICLIR film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg (see section 4.2 and 5.1).
Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
The recommended dose is 200 mg (one tablet) administered twice daily (once every 12 hours) for 10 days (see section 5.1).
DIFICLIR 40 mg/ml granules for oral suspension may be used in adult patients with difficulties in swallowing tablets.
Fidaxomicin 200 mg tablets administered twice daily for days 1-5 (no intake of a tablet on day 6) then once daily on alternate days for days 7-25 (see section 5.1).
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.
No dose adjustment is considered necessary (see section 5.2).
No dose adjustment is considered necessary. Due to the limited clinical data in this population, fidaxomicin should be used with caution in patients with severe renal impairment (see sections 4.4 and 5.2).
No dose adjustment is considered necessary. Due to the limited clinical data in this population, fidaxomicin should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
The recommended dose in paediatric patients weighing at least 12.5 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.
Reduced doses are recommended for patients with a body weight of less than 12.5 kg. See the SmPC of DIFICLIR 40 mg/ml granules for oral suspension.
DIFICLIR is intended for oral use.
The film-coated tablets should be administered whole with water.
They can be taken with or without food.
No adverse reactions for acute overdose have been reported during clinical studies or from post-marketing data. However, the potential for adverse reactions cannot be ruled out and general supportive measures are recommended.
3 years.
This medicinal product does not require any special storage conditions.
100 × 1 film-coated tablet in alu/alu perforated unit dose blisters.
20 × 1 film-coated tablet in alu/alu perforated unit dose blisters.
Not all pack sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
