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Xifaxanta™ gets to work here ...and only here1,2


The first and only virtually non-absorbed antibiotic licensed for the treatment of non-invasive Travellers’ Diarrhoea3


XIFAXANTA™ Prescribing Information REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING. Presentation: Film-coated


tablet containing


rifaximin


200 mg. Uses: Xifaxanta is indicated for the treatment of travellers’ diarrhoea that is not associated with fever, bloody diarrhoea, eight or more unformed stools in the previous 24 h, occult blood or leucocytes in the stool. Dosage and administration: Adults over 18 years of age: 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. Not


recommended in children under 18 years of age.


Contraindications: Hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or rifabutin) or to any of the excipients. Warnings and precautions for use: Not recommended for the treatment of caused


by invasive enteric pathogens.


travellers’ diarrhoea If


worsen, treatment with rifaximin should be interrupted. If symptoms have not resolved after 3 days of treatment, or recur shortly afterwards, a second course is not recommended. The potential association of rifaximin treatment with Clostridium difficile associated


diarrhoea and


colitis cannot be ruled out. Interactions: Due to the negligible gastrointestinal absorption of orally administered rifaximin (less than 1%), the systemic drug interaction potential


is low. Rifaximin


concomitantly with other rifamycins and the tablets should not be administered for at least


the administration of charcoal. Pregnancy and lactation: Rifaximin is not


should not be administered two hours after


recommended during pregnancy and in


women of childbearing potential not using contraception. The benefits of rifaximin treatment should be assessed against the need to continue breastfeeding.Undesirable effects: Common effects reported in clinical trials are dizziness, defecation


headache, urgency,


simplex symptoms


abdominal diarrhoea,


infections, pain, clostridial flatulence,


constipation, bloating,


distension, nausea, vomiting, rectal tenesmus and pyrexia. Other effects that have been reported are candidiasis, herpes


and legal infections,


palpitations, increased blood pressure, liver function test abnormalities, blood disorders (e.g. thrombocytopenia) and anaphylactic reactions, (e.g. angioedemas,hypersensitivity and skin reactions). Licensing


pseudomembranous


Legal category: POM. Cost: Basic NHS price £15.15 (9 tablets). MA number: PL 20011/0021. For


category: further


information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall


Road, Harefield, Middlesex,


UB9 6NS. 01895 826606. E-mail: medinfo@norgine.com. Date of preparation/revision: XIF/2553/AUG/11.


Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk.


Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on 01895 826606.


References 1. Jiang ZD et al. Antimicrob Agents Chemother 2000;44 (8):2205-2206.


2. Descombe JJ et al. Int J Clin Pharmacol Res 1994;14 (2):51-56.


3. Xifaxanta™ Summary of Product Characteristics.


XIFAXANTA is a trademark of Alfa- Wassermann Hungary KFT, exclusively licensed in the UK to the Norgine group of companies.


XIF/2757/JAN/12. Date of preparation: January 2012.


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