Normacol

NORMACOL

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

Oral granules.

White irregular shaped granules.

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.

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.

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

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.

None known.

NORMACOL may be used during pregnancy or lactation.

None known.

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.

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.

Sterculia acts in the colon by forming a soft bulky stool and inducing a laxative effect.

Sterculia is not absorbed or digested in the gastrointestinal tract and its laxative action is normally effective within 12 hours of oral administration.

There is no evidence that Sterculia has a significant systemic toxicity potential.

Sodium hydrogen carbonate

Sucrose

Talc

Hard paraffin

Titanium dioxide

Vanillin

None known.

Sachet and lined carton: 2 years

Store in a dry place below 25°C.

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

None.

Norgine Limited

Norgine House

Widewater Place

Moorhall Road

Harefield

Uxbridge

UB9 6NS

UK

PL 00322/5010R

January 1991

01 December 2020