1. Name Of The Medicinal Product
Fybogel, Fybogel Orange and Fybogel Lemon.
2. Qualitative And Quantitative Composition
A sachet 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
The product 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 one level measure 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
The product is contra-indicated in cases of intestinal obstruction and colonic atony such as senile mega-colon.
4.4 Special Warnings And Precautions For Use
Due to its aspartame content the product 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
The product 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 the product 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
Fybogel Orange
Potassium bicarbonate USP
Sodium bicarbonate Ph Eur
Citric acid Ph Eur
Povidone K90 Ph Eur
Beta-carotene 1% (E160a)
Aspartame Ph Eur
Orange flavour
Saccharin sodium Ph Eur
Fybogel Lemon contains curcumin and lemon flavouring.
Fybogel contains no flavouring.
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
Thirty sachets enclosed in a carton.
6.6 Special Precautions For Disposal And Other Handling
The 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 0063/0026; PL 0063/0023; PL 0063/0024.
9. Date Of First Authorisation/Renewal Of The Authorisation
24th April, 1995/26th June, 1997; 6th July, 1998; 20th August, 1997.
10. Date Of Revision Of The Text
13th June, 2001.
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