Fybogel Lemon

1. Name Of The Medicinal Product

Fybogel Lemon.

2. Qualitative And Quantitative Composition

A sachet contains 3.5 g ispaghula husk BP.

3. Pharmaceutical Form

Granules.

4. Clinical Particulars

4.1 Therapeutic Indications

Clinical Indication: for 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 Lemon is intended for oral administration in a suspension in a drink of water. The granules should be stirred into a glass of water and taken as soon as possible, preferably after meals.

Adults and children over 12 years:	One sachet 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 size and age, morning and evening. If there has been no bowel movement after three days of treatment the doctor should be consulted.
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 Lemon 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 Lemon should not be given to patients with phenylketonuria.

If symptoms persist consult a doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Fybogel Lemon 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 its physical mode of action

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.

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 Lemon 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
Aspartame	Ph Eur
Lemon flavour no. 1	HSE
Lemon flavour no. 4	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 of paper/aluminium foil/polythene laminate. One, seven, ten or thirty sachets in a cardboard outer. (Pack sizes printed in bold are currently sold).

6.6 Special Precautions For Disposal And Other Handling

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

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

HULL,

HU8 7DS,

England.

8. Marketing Authorisation Number(S)

PL 00063/0024.

9. Date Of First Authorisation/Renewal Of The Authorisation

24th April, 1995 / 20th August, 1997.

10. Date Of Revision Of The Text

19/01/2007