Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK
TARGAXAN is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥18 years of age (see section 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Recommended dose: 550 mg twice a day as long term treatment for the reduction in recurrence of episodes of overt hepatic encephalopathy (see sections 4.4, 5.1 and 5.2).
In the pivotal study, 91% of the patients were using concomitant lactulose (see also section 5.1).
TARGAXAN can be administered with or without food.
The safety and efficacy of TARGAXAN in paediatric patients (aged less than 18 years) have not been established.
No dosage adjustment is necessary as the safety and efficacy data of TARGAXAN showed no differences between the elderly and the younger patients.
No dosage adjustment is necessary for patients with hepatic insufficiency (see section 4.4).
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.
No case of overdose has been reported.
In clinical trials with patients suffering from traveller’s diarrhoea doses of up to 1800 mg/day have been tolerated without any severe clinical sign. Even in patients/subjects with normal bacterial flora rifaximin in dosages of up to 2400 mg/day for 7 days did not result in any relevant clinical symptoms related to the high dosage.
In case of accidental overdose, symptomatic treatment and supportive care are suggested.
3 years.
This medicinal product does not require any special storage conditions.
PVC-PE-PVDC/Aluminium foil blisters in cartons of 14, 28, 42, 56 or 98 tablets.
Not all pack-sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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