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.
3 PHARMACEUTICAL FORM
Oral granules.
White irregular shaped 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
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.
4.5. Interactions with other Medicinal Products and other Forms of Interaction
4.6 Fertility, pregnancy and lactation Fertility, 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
|
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 at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
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. 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. Pre-clinical Safety Data
There is no evidence that Sterculia has a significant systemic toxicity potential.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium hydrogen carbonate
Sucrose
Talc
Hard paraffin Titanium dioxide Vanillin
6.2. Incompatibilities
None known.
Shelf life
6.3
6.4.
6.5.
6.6.
7
Sachet and lined carton: 2 years Special Precautions for Storage
Store in a dry place below 25°C.
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.
Instructions for Use/Handling None.
MARKETING AUTHORISATION HOLDER
Norgine Limited Norgine House Widewater Place Moorhall Road Harefield Uxbridge
Middlesex UB9 6NS United Kingdom
MARKETING AUTHORISATION NUMBER(S)
PL 00322/5010R 9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION
January 1991
10
DATE OF REVISION OF THE TEXT
31/03/2016