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

Reckitt Benckiser Healthcare (UK) Ltd
Freepost, RSBU-TEBT-GSTU, Reckitt Benckiser, Kingston Upon Thames, KT2 6LZ, UK
Telephone: +44 (0)500 455 456
WWW: http://www.reckittbenckiser.com
Medical Information Direct Line: +44 (0)500 455 456
Customer Care direct line: +44 (0)500 455 456

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: 19/12/2011
SPC Fybogel Hi-Fibre Lemon


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

Senokot Hi-Fibre Lemon

Or

Fybogel Hi-Fibre Lemon


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

A sachet contains 3.5g ispaghula husk BP.

For excipients see Section 6.1.


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 haemorrhoids.


Go to top of the page
4.2 Posology and method of administration

Senokot Hi-Fibre 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.


Go to top of the page
4.3 Contraindications

Senokot Hi-Fibre 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 Senokot Hi-Fibre Lemon should not be given to patients with phenylketonuria.

If symptoms persist consult a doctor.

Senokot Hi-Fibre Lemon should not be given to patients with natural or drug induced failure of gut motility.


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

Senokot Hi-Fibre 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

Pharmacotherapeutic classification: A06A C01 Bulk producer

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 Senokot Hi-Fibre 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

Sodium bicarbonate

Citric acid

Riboflavine sodium phosphate

Aspartame

Lemon flavour no. 1

Lemon flavour no. 4

Saccharin Sodium

Polysorbate 80

Silica colloidal anhydrous


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. 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 20, 24, 28 or 30 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

Senokot Hi-Fibre 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

United Kingdom


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

PL 00063/0150.


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

03/08/2009


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

03/08/2009



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/23318/SPC/


Active Ingredients/Generics

 
  ispaghula husk