Fybogel Orange

1. Name Of The Medicinal Product

Fybogel Orange.

2. Qualitative And Quantitative Composition

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

3. Pharmaceutical Form

Effervescent granules.

4. Clinical Particulars

4.1 Therapeutic Indications

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.

4.2 Posology And Method Of Administration

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.

Adults and children over 12 years:	One sachet or two level 5ml spoonfuls morning and evening.
Elderly:	There is no indication that dosage needs to be modified for the elderly.
Children aged 6 to 12 years:	Half to one level 5 ml spoonful, depending on age and size, morning and evening.
Children under 6 years:	To be taken only when prescribed by a doctor, half to one level 5 ml spoonful depending on age and size, morning and evening.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

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

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

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

4.9 Overdose

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

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

5.3 Preclinical Safety Data

No preclinical findings relevant to the prescriber have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Potassium bicarbonate	USP
Sodium bicarbonate	Ph Eur
Citric acid	Ph Eur
Riboflavin sodium phosphate	Ph Eur
Beta-carotene 10% (E160a)	HSE
Aspartame	Ph Eur
Orange flavour	HSE
Saccharin sodium	Ph Eur
Polysorbate 80	Ph Eur
Silica, colloidal anhydrous	Ph Eur

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store below 30°C in a dry place.

6.5 Nature And Contents Of Container

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

6.6 Special Precautions For Disposal And Other Handling

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

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS.

8. Marketing Authorisation Number(S)

PL 00063/0026

9. Date Of First Authorisation/Renewal Of The Authorisation

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

10. Date Of Revision Of The Text

19/01/2007