Normacol
Summary of product characteristics
1. Name of the medicinal product
NORMACOL
2. Qualitative and quantitative composition
The active ingredient is Sterculia BP 62% w/w.
Excipients with known effect:
Sodium
Sucrose
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral granules.
White irregular shaped granules.
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
Posology
Adults: 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals
Older People : As adult dose.
Paediatric population
Children: (6-12 years): one half the above amount
NORMACOL is not recommended for children under 6 years of age
Method of administration
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 the active substances or to any of the excipients listed in section 6.1
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.
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.
Possible fluid and electrolyte depletion in association with diarrhoea.
Take with plenty of water to reduce the risk of oesophageal obstruction.
Adequate fluid intake should be maintained.
This medicinal product contains 28.7 mg sodium per dose, equivalent to 1.5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Fertility, pregnancy and lactation
NORMACOL may be used during pregnancy or lactation.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
| System Organ Class
| Adverse Drug Reaction
|
| Immune system disorders
| Allergic reactions
|
| Gastrointestinal disorders
| Oesophageal obstruction, intestinal/colonic obstruction or impaction, abdominal distension, flatulence, diarrhoea, nausea, abdominal pain
|
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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. If there is profound diarrhoea, dehydration and electrolyte depletion may occur.
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.
6.1. List of excipients
Sodium hydrogen carbonate
Sucrose
Talc
Hard paraffin
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.
Not all pack sizes may be marketed
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorisation holder
Norgine Limited
Norgine House
Widewater Place
Moorhall Road
Harefield
Uxbridge
UB9 6NS
UK
8. Marketing authorisation number(s)
PL 00322/5010R
9. Date of first authorisation/renewal of the authorisation
January 1991
10. Date of revision of the text
01 December 2020
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
Posology
Adults: 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals
Older People : As adult dose.
Paediatric population
Children: (6-12 years): one half the above amount
NORMACOL is not recommended for children under 6 years of age
Method of administration
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 the active substances or to any of the excipients listed in section 6.1
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.
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.
Possible fluid and electrolyte depletion in association with diarrhoea.
Take with plenty of water to reduce the risk of oesophageal obstruction.
Adequate fluid intake should be maintained.
This medicinal product contains 28.7 mg sodium per dose, equivalent to 1.5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
NORMACOL may be used during pregnancy or lactation.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
| System Organ Class
| Adverse Drug Reaction
|
| Immune system disorders
| Allergic reactions
|
| Gastrointestinal disorders
| Oesophageal obstruction, intestinal/colonic obstruction or impaction, abdominal distension, flatulence, diarrhoea, nausea, abdominal pain
|
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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Drug Licencing
Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).