1. Name Of The Medicinal Product
Senokot Hi-Fibre Orange
Or
Fybogel Hi-Fibre Orange
2. Qualitative And Quantitative Composition
A sachet contains 3.5g ispaghula husk BP.
3. Pharmaceutical Form
Effervescent granules.
4. Clinical Particulars
4.1 Therapeutic Indications
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.
4.2 Posology And Method Of Administration
Senokot Hi-Fibre Orange 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 possible, preferably after meals.
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4.3 Contraindications
Senokot Hi-Fibre Orange is contraindicated in cases of intestinal obstruction, faecal impaction and colonic atony such as senile megacolon
4.4 Special Warnings And Precautions For Use
If symptoms persist consult your doctor. Due to its aspartame content Senokot Hi-Fibre Orange should not be given to patients with phenylketonuria.
Senokot Hi-Fibre Orange should not be given to patients with natural or drug induced failure of gut motility.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
Senokot Hi-Fibre Orange may be used during pregnancy, 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 Senokot Hi-Fibre Orange 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
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6.2 Incompatibilities
None known.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Store below 30°C in a dry place.
6.5 Nature And Contents Of Container
7, 8, 10, 12, 14, 20, 24, 28 or 30 sachets enclosed in a cardboard outer.
Polypropylene tubs with polyethylene lid containing 150 g of product.
6.6 Special Precautions For Disposal And Other Handling
Senokot Hi-Fibre Orange granules are to be dispersed in water forming a drink.
7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS
United Kingdom
8. Marketing Authorisation Number(S)
PL 00063/0064
9. Date Of First Authorisation/Renewal Of The Authorisation
7th December 1998
10. Date Of Revision Of The Text
21/01/2008
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