Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Norgine Pharmaceuticals Ltd, Moorhall Road, Harefield, Middlesex, UB9 6NS
Xifaxanta 200mg film-coated tablets are indicated for the treatment of travellers' diarrhoea that is not associated with any of:
Xifaxanta 200mg film-coated tablets may shorten the duration of diarrhoea when this is associated with non-invasive strains of E.coli (see sections 4.4 and 5.1).
200 mg every 8 hours for three days (total 9 doses).
Rifaximin must not be used for more than 3 days even if symptoms continue and a second course of treatment must not be taken (see section 4.4).
Rifaximin can be administered with or without food.
The safety and efficacy of Xifaxanta 200 mg film-coated tablets in children (aged less than 18 years) have not been established
No dosage adjustment is necessary as the safety and efficacy data of Xifaxanta 200 mg film-coated tablets showed no differences between the elderly and the younger patients.
A dosage adjustment for patients with hepatic insufficiency is not necessary (see section 5.2).
Although dosing change is not anticipated, caution should be used in patients with impaired renal function (see section 5.2).
Orally with a glass of water.
In clinical trials with patients suffering from travellers' diarrhoea doses of up to 1800 mg/day have been tolerated without any severe clinical signs.
Dosages of up to 2400 mg/day for 7 days in patients/subjects with normal bacterial flora rifaximin did not result in any relevant clinical symptoms related to the high dosage.
In case of overdose symptomatic treatments and supportive care are recommended.
Original packaging: 3 years.
This medicinal product does not require any special storage conditions.
PVC/PE/PVDC-Aluminium blister pack containing 9 tablets.
No special requirements.
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