DIFICLIR 200 mg film-coated tablets
*Company:
Tillotts Pharma GmbHStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 January 2023
File name
PIL DIF tab Dec 2022.pdf
Reasons for updating
- Change to section 3 - dose and frequency
Updated on 13 January 2023
File name
SPC DIF tab Dec 2022.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Posology
Adults
Standard dosing
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.
Extended-pulsed dosing
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.
Updated on 20 January 2022
File name
SPC DIF tab Mar 2021.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 January 2022
File name
PIL DIF tab May 2021.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 15 March 2021
File name
SmPC DIF tab.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 March 2021
File name
PIL DIF tab.pdf
Reasons for updating
- New PIL for new product