Mutaflor Escherichia coli strain Nissle 1917 is the only probiotic registered in Australia at AUST R level. AUST R 194957

This means the regulatory pathway was no different to that of a prescription medicine and as such was examined for: Safety, Quality and Efficacy.

Mutaflor is registered in Australia at AUST R level for the relief and management of chronic constipation.

Your healthcare practitioner may also wish to utilise this strain for its pharmacological and metabolic properties.

Characteristics of Escherichia coli strain Nissle 1917:

- the ability to colonize

- antagonistic activity â inhibition of growth and or killing of pathogens

- anti-invasive â prevention of colonisation in the gut by pathogens

- synthesis of endogenous antimicrobial peptides-defensins

- mucosal integrity â contributing to luminal metabolism and stability of intestinal milieu-enhanced epithelial barrier function

- anti-inflammatory and immunomodulatory effects

- stimulation of colonic mucosa

The therapeutic effects of Mutaflor are strain specific and have been demonstrated by in-vitro and in-vivo experiments and clinical studies. Mutaflor® Escherichia coli strain Nissle 1917 (EcN) is arguably one of the best studied and field tested probiotic strains and fulfills all the demanding criteria and characteristics required for a medicinal probiotic.

• Mutaflor is a probiotic that comprises as its active ingredient a viable non-pathogenic strain of Escherichia coli (E.coli). Escherichia coli strain Nissle 1917

The standard dose should be taken with a meal, if possible with breakfast, and an appropriate amount of fluid.

Swallow capsule whole, DO NOT break or chew.

With the onset of flatulence or if your Doctor or Health care Practitioner recommends a daily dose higher than the standard dose, the daily dose may be split and administered with meals spread evenly throughout the day.

The capsules are enteric coated, reddish brown in colour and cannot be pulled apart. This colouring is part of the enteric coating and ensures that the capsule will not degrade and open until the start of the large intestine is reached. The capsule contents are a beige powder.

Constipation may be associated with other medical conditions. Any change in bowel habits should be discussed with your doctor to exclude these. Further investigation may be required.

Warning Do not take Mutaflor: 1. If you are allergic (hyper sensitive) to E.coli strain Nissle 1917 or any of the ingredients of Mutaflor listed at the end of the information leaflet. 2. Taking other medicinal products - Please tell your Doctor or Healthcare Practitioner if you are taking or have recently taken any other medicinal products, including medicinal products obtained without a prescription. Some medicines may interfere with Mutaflor. These include: Certain antibiotics and sulphonamides as they may reduce the efficacy of Mutaflor.

Pregnancy and breast feeding: The bacterium E.coli strain Nissle 1917 contained in Mutaflor is a natural coloniser of the gut. Its presence and mode of action is restricted to the gastrointestinal tract. When used in accordance with the instructions there are no known risks during pregnancy and breast-feeding.

Possible Side Effects: After the beginning of administration, flatulence is common. Very rarely, undesired effects of the gastrointestinal tract such as abdominal pain, gut noises, loose stools or diarrhoea, nausea and vomiting may occur. Very rarely, cases of skin reddening or rashes may occur. Also very rarely, cases of headache may occur. If any of these side effects were to get serious, or if you notice any side effects not listed in this leaflet, please tell your Healthcare Practitioner.