NORMACOL
Active substance: STERCULIA
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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.
4. 4.1.
CLINICAL PARTICULARS 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. As adult dose. (6-12 years): one half the above amount.
Elderly: Children:
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. Interactions 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. 5.1.
PHARMACOLOGICAL PROPERTIES 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. 6.1.
PHARMACEUTICAL PARTICULARS List of Excipients Sodium bicarbonate BP Sucrose BP Talc USP Paraffin wax
Titanium dioxide BP Vanillin BP
6.2.
Incompatibilities None known.
6.3 6.4.
Shelf life
Sachet and lined carton: 2 years
Special Precautions for Storage Store in a dry place below 25C.
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.
Instructions for Use/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 00322/5010R
9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION January 1991
10
DATE OF REVISION OF THE TEXT
12/12/2012
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.
4. 4.1.
CLINICAL PARTICULARS 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. As adult dose. (6-12 years): one half the above amount.
Elderly: Children:
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. Interactions 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. 5.1.
PHARMACOLOGICAL PROPERTIES 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. 6.1.
PHARMACEUTICAL PARTICULARS List of Excipients Sodium bicarbonate BP Sucrose BP Talc USP Paraffin wax
Titanium dioxide BP Vanillin BP
6.2.
Incompatibilities None known.
6.3 6.4.
Shelf life
Sachet and lined carton: 2 years
Special Precautions for Storage Store in a dry place below 25C.
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.
Instructions for Use/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 00322/5010R
9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION January 1991
10
DATE OF REVISION OF THE TEXT
12/12/2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
