XIFANANTA Film-coated tablet Ref.[7348] Active ingredients: Rifaximin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Norgine Pharmaceuticals Ltd, Moorhall Road, Harefield, Middlesex, UB9 6NS

Product name and form

XIFAXANTA 200 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Pink, circular biconvex film-coated tablets, with “AW” embossed on one side.

Qualitative and quantitative composition

One film-coated tablet contains: Rifaximin 200 mg.

Excipients: For the full list of excipients, see section 6.1.

Active Ingredient Description
Rifaximin

Rifaximin is an antibacterial agent of the rifamycin class that inhibits bacterial RNA synthesis. Rifaximin has a broad antimicrobial spectrum against most of the Gram-positive and -negative, aerobic and anaerobic bacteria responsible for intestinal infections.
List of Excipients

Tablet core:

Sodium starch glycolate type A
Glycerol distearate
Colloidal anhydrous silica
Talc
Microcrystalline cellulose

Tablet coat:

Hypromellose
Titanium dioxide E171
Disodium edetate
Propylene glycol
Red iron oxide E172

Pack sizes and marketing

PVC/PE/PVDC-Aluminium blister pack containing 9 tablets.

Marketing authorization holder

Norgine Pharmaceuticals Ltd, Moorhall Road, Harefield, Middlesex, UB9 6NS

Marketing authorization dates and numbers

PL 20011/0021

02/12/2010 / 20/07/2016

 
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