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1. Name Of The Medicinal Product
NORMACOL.
2. Qualitative And Quantitative Composition
The active ingredient is Sterculia 62% w/w.
3. Pharmaceutical Form
Oral granules.
4. Clinical Particulars
4.1 Therapeutic Indications
The treatment of constipation, particularly simple or idiopathic constipation and constipation during pregnancy.
Management of colostomies and ileostomies.
The 'High Residue Diet' management of diverticular disease of the colon and other conditions requiring a high fibre regimen.
The initiation and maintenance of bowel action after rectal and anal surgery.
Administration after ingestion of sharp foreign bodies to provide a coating and reduce the possibility of intestinal damage during transit.
4.2 Posology And Method Of Administration
Adults: 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals.
Elderly: As adult dose.
Children: (6-12 years): one half the above amount.
The granules should be placed dry on the tongue and without chewing or crushing, swallowed immediately with plenty of water or a cool drink. Prior to drinking they may also be sprinkled onto and taken with soft food such as yoghurt.
4.3 Contraindications
Intestinal obstruction, faecal impaction, and total atony of the colon.
Known hypersensitivity to any of the ingredients
4.4 Special Warnings And Precautions For Use
Caution should be exercised in cases of ulcerative colitis.
Patients with rare hereditary problems of fructose intolerance, glucose –galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Not to be taken immediately before going to bed or in a recumbent position especially in the elderly. Adequate fluid should be maintained.
Not to be taken for more than 4 days if there has been no movement of the bowels.
It is not unusual for stool to appear paler in colour than normal as a result of local contact with sterculia. This does not indicate anything untoward.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
NORMACOL may be recommended during pregnancy or lactation.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Immune system disorders:
Allergic reactions
Gastrointestinal disorders:
Intestinal/colonic obstruction or impaction, flatulence
Occasionally mild abdominal distension may occur.
Oesophageal obstruction is possible if the product is taken in overdosage or if it is not adequately washed down with fluid.
4.9 Overdose
Intestinal obstruction is possible in overdosage particularly in combination with inadequate fluid intake. Management is as for intestinal obstruction from other causes.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Sterculia acts in the colon by forming a soft bulky stool and inducing a laxative effect.
5.2 Pharmacokinetic Properties
Sterculia is not absorbed or digested in the gastrointestinal tract and its laxative action is normally effective within 12 hours of oral administration.
5.3 Preclinical Safety Data
There is no evidence that Sterculia has a significant systemic toxicity potential.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium bicarbonate
Sucrose
Talc
Paraffin wax
Titanium dioxide
Vanillin
6.2 Incompatibilities
None known.
6.3 Shelf Life
Sachet and lined carton: 2 years
6.4 Special Precautions For Storage
Store in a dry place below 25°C.
6.5 Nature And Contents Of Container
Sachet containing 7 g of white granules in boxes of 2, 7, 30 or 60 sachets.
Lined box of 100 g or 500 g of white granules.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Norgine Limited
Norgine House
Widewater Place
Moorhall Road
Harefield
UXBRIDGE
Middlesex UB9 6NS
United Kingdom
8. Marketing Authorisation Number(S)
PL 0322/5010R
9. Date Of First Authorisation/Renewal Of The Authorisation
January 1991
10. Date Of Revision Of The Text
July 2010
Normacol
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