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XIFAXAN FILM-COATED TABLET 550MG [SIN14761P]
Active ingredients: XIFAXAN FILM-COATED TABLET 550MG
Last updated 26 October 2025
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Product Info
XIFAXAN FILM-COATED TABLET 550MG
[SIN14761P]
Product information
Active Ingredient and Strength | RIFAXIMIN - 550 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | ALFASIGMA S.P.A. - ITALY |
Registration Number | SIN14761P |
Licence Holder | UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A07AA11 |
4.1 Therapeutic indications
XIFAXAN is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
In the pivotal study, 91% of the patients were using concomitant lactulose.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 Posology and method of administration
Posology
Recommended dose: 550 mg twice a day. The clinical benefit was established from a controlled study in which subjects were treated for 6 months. Treatment beyond 6 months should take into consideration the individual balance between benefits and risks, including those associated with the progression of hepatic dysfunction (see sections 4.4, 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
XIFAXAN can be administered with or without food.
Paediatric population
The safety and efficacy of XIFAXAN in paediatric patients (aged less than 18 years) have not been established.
Elderly
No dosage adjustment is necessary as the safety and efficacy data of XIFAXAN showed no differences between the elderly and the younger patients.
Hepatic impairment
No dosage adjustment is necessary for patients with hepatic insufficiency (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Renal impairment
Although dosing change is not anticipated, caution should be used in patients with impaired renal function (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Method of administration
Orally with a glass of water.
4.3 Contraindications
Hypersensitivity to rifaximin, rifamycin-derivatives or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Cases of intestinal obstruction.