Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Forum Health Products Limited

Forum Health Products Limited, Betchworth House, 57/65 Station Road, Redhill, Surrey, RH1 1DL
Telephone: +44 (0)1737 857 782
Fax: +44 (0) 1737 857701
WWW: http://www.forum.co.uk
Medical Information Direct Line: 0500 455 456
Customer Care direct line: 0500 455 456

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 02/08/2010
SPC Fybogel Lemon


Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

Fybogel Lemon.


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

A sachet contains 3.5 g ispaghula husk BP.


Go to top of the page
3. PHARMACEUTICAL FORM

Granules.


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
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.


Go to top of the page
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.


Go to top of the page
4.3 Contraindications

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


Go to top of the page
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.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

None known.


Go to top of the page
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.


Go to top of the page
4.7 Effects on ability to drive and use machines

Not applicable in view of its physical mode of action


Go to top of the page
4.8 Undesirable effects

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


Go to top of the page
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.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
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.


Go to top of the page
5.2 Pharmacokinetic properties

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


Go to top of the page
5.3 Preclinical safety data

No preclinical findings relevant to the prescriber have been reported.


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
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


Go to top of the page
6.2 Incompatibilities

None known.


Go to top of the page
6.3 Shelf life

Three years.


Go to top of the page
6.4 Special precautions for storage

Store below 30°C in a dry place.


Go to top of the page
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).


Go to top of the page
6.6 Special precautions for disposal and other handling

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


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

HULL,

HU8 7DS,

England.


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PL 00063/0024.


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

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


Go to top of the page
10. DATE OF REVISION OF THE TEXT

19/01/2007



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/10870/SPC/


Active Ingredients/Generics

 
  ispaghula husk