Normacol

1. Name Of The Medicinal Product

NORMACOL.

2. Qualitative And Quantitative Composition

The active ingredient is Sterculia 62% w/w.

3. Pharmaceutical Form

Oral 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

Adults: 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals.

Elderly: As adult dose.

Children: (6-12 years): one half the above amount.

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 Interaction 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. 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 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium bicarbonate

Sucrose

Talc

Paraffin wax

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.

6.6 Special Precautions For Disposal And Other 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 0322/5010R

9. Date Of First Authorisation/Renewal Of The Authorisation

January 1991

10. Date Of Revision Of The Text

July 2010