FYBOGEL PLAIN

1. Name Of The Medicinal Product

Fybogel.

2. Qualitative And Quantitative Composition

Each single dose sachet contains 3.5g ispaghula husk BP.

3. Pharmaceutical Form

Effervescent granules for preparation of an oral suspension

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of patients requiring a high fibre regimen: 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 should be stirred into a glass of water and taken as soon as effervescent subsides, preferably after meals.

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

4.3 Contraindications

Fybogel is contra-indicated in cases of intestinal obstruction, faecal impaction and colonic atony such as senile mega-colon.

4.4 Special Warnings And Precautions For Use

Due to its aspartame content, Fybogel 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 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

Not applicable in view of physical mode of action.

4.8 Undesirable Effects

None known

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 it own weight of 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 a consequent softening of the faeces.

5.2 Pharmacokinetic Properties

The mode of action of Fybogel 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-caotene 10 % (E160a)	HSE
Aspartame	Ph Eur
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 of paper/aluminium foil/polythene laminate enclosed in a cardboard outer carton.

Pack size(s): Ten or thirty sachets (pack size printed in bold is currently sold).

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0023

9. Date Of First Authorisation/Renewal Of The Authorisation

15/01/1990 / 09/06/2003

10. Date Of Revision Of The Text

17/01/2007