Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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Each gram of NORMACOL Granules contains 0.62g of Sterculia (62% w/w).
Each sachet contains 4.34g of sterculia.
For excipients, see 6.1
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Granules.
White irregular shaped granules with an odour of vanillin.
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The treatment of constipation (including pregnancy and lactation)
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.
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Adults (including the elderly): 1 or 2 sachets or 1-2 heaped 5ml
spoonfuls, once or twice daily after meals.
Children (6-12 years): one half the above amount or as directed by the physician.
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.
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Intestinal obstruction, faecal impaction, and total atony of the colon.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Use in patients with a sensitivity to sterculia.
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Not to be taken immediately before retiring, especially in the elderly. Adequate fluid should be maintained. Caution should be exercised in cases of ulcerative colitis. Not to be taken for more than 4 days if there has been no movement of the bowels.
4.5. Interactions with other medicines products and other forms of Interaction
None known.
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NORMACOL may be recommended during pregnancy or lactation.
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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.
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Intestinal obstruction is possible in overdosage particularly in combination with inadequate fluid intake. Management is as for intestinal obstruction from other causes.
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Sterculia acts in the colon by forming a soft bulky stool and inducing a laxative effect.
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Sterculia is not absorbed or digested in the gastrointestinal tract and its laxative action is normally effective within 12 hours of oral administration.
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There is no evidence that Sterculia has a significant systemic toxicity potential.
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Sucrose
Talc
Sodium hydrogen carbonate
Paraffin wax
Titanium dioxide (E171)
Vanillin
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Sachet and lined carton: 2 years.
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Sachet: Do not store above 25°C. Store in original package in a dry place.
Carton: Do not store above 25°C. Store in original package in a dry place. Keep the carton tightly closed.
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Sachet: Laminate consisting of 4 layers of low density polyethylene; aluminium; low density polyethylene and paper.
Sachet containing 7 g of white granules in boxes of 2, 7, or 60 sachets. Not all pack sizes may be marketed
Lined carton: Laminate consisting of 4 layers of low density polyethylene; aluminium; low density polyethylene and paper.
Lined box of 500 g of white granules.
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Norgine Limited
Chaplin House
Widewater Place
Moorhall Road
Harefield
UXBRIDGE
Middlesex UB9 6NS
United Kingdom
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25 September 1984/ 25th September 2004
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Date revised: November 2006.
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