Fybogel Orange.

A unit dose (one sachet or two level 5 ml spoonfuls) contains 3.5 g ispaghula husk BP.

Effervescent granules.

The treatment of patients requiring a high fibre regime: for example, for the relief of constipation, including constipation in pregnancy and the maintenance of regularity; for the management of bowel function in patients with colostomy, ileostomy, haemorrhoids, anal fissure, chronic diarrhoea associated with diverticular disease, irritable bowel syndrome and ulcerative colitis.

Fybogel Orange is intended for oral use as a suspension in a drink of water. The granules should be stirred into a glass of water and taken as soon as the effervescence subsides, preferably after meals.

Fybogel Orange is contraindicated in cases of intestinal obstruction, faecal impaction and colonic atony such as senile megacolon.

Due to its aspartame content Fybogel Orange should not be given to patients with phenylketonuria.

None known.

Fybogel Orange may be used during pregnancy and lactation since the ispaghula husk is not absorbed from the gastrointestinal tract.

None.

A small amount of abdominal distension and flatulence may sometimes occur.

In the event of overdosage conservative measures should be taken. The patient may notice abdominal discomfort and flatulence, and attention should be paid to maintaining an adequate fluid intake, particularly if the granules have been taken without water contrary to administration instructions.

Ispaghula husk is capable of absorbing up to 40 times its own weight in water in vitro, and part of its activity can be attributed to its action as a simple bulking agent. In addition, colonic bacteria are believed to use the hydrated material as a metabolic substrate. This results in an increase in the bacterial cell mass with consequent softening of the faeces.

The mode of action of Fybogel Orange is physical and does not depend on absorption into the systemic circulation.

No preclinical findings relevant to the prescriber have been reported.

None known.

Three years.

Store below 30°C in a dry place.

Sachets, one, seven, ten or thirty sachets enclosed in a carton. Tub containing 100-300 g Fybogel Orange.

Fybogel Orange granules are to be dispersed in water forming a drink.

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS.

PL 00063/0026

24^th April 1995 / 26^th June 1997.

19/01/2007