Normacol 6,2 g per 10 g Granules.

NORMACOL is indicated in adults and children over the age of 6 years for:

• The treatment of constipation, particularly simple or idiopathic constipation and constipation during pregnancy and lactation.
• Management of colostomies and ileostomies.
• The u2018High Residue Dietu2019 management of diverticular disease of the colon and other conditions requiring a high fibre regimen.
• Relief of symptoms of irritable bowel syndrome.
• 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

Adolescents and adults (including the elderly): Take one to two heaped medicine measures, once or twice daily. Take after meals. NORMACOL generally produces a bowel movement in 12 to 72 hours.

Special populations

Elderly: See Posology above.

Renal impairment: The safety and efficacy of NORMACOL in patients with renal impairment has not been established.

Hepatic impairment: The safety and efficacy of NORMACOL in patients with hepatic impairment has not been established.

Paediatric population: Children (6 to 12 years): One half the adult dose or as directed by the medical practitioner or pharmacist. NORMACOL is not recommended for children under the age of 6 years (see section 4.3).

Method of administration

NORMACOL granules should be placed dry on the tongue, in small quantities if necessary, and, without chewing or crushing, swallowed immediately with plenty of water or a cool drink. The granules may also be sprinkled onto and taken with soft food such as yoghurt and then immediately drink plenty of water or a cool drink.

NORMACOL is contraindicated in:

• Patients with hypersensitivity to sterculia or to any of the excipients in NORMACOL (see section 6.1).
• Patients with intestinal obstruction.
• Patients with faecal impaction, colonic atony and other conditions where the administration of an intestinal evacuant is inadvisable.
• Children under the age of 6 years.

NORMACOL should not be taken immediately before going to bed or in a recumbent position especially in the elderly. Possible fluid and electrolyte depletion in association with diarrhoea. Patients should take NORMACOL with plenty of water to reduce the risk of faecal impaction, large bowel obstruction and oesophageal obstruction. Adequate fluid intake should be maintained. NORMACOL should not be used in the presence of abdominal pain, nausea and vomiting. NORMACOL should not be used for a period longer than one week, unless directed by a doctor.

It is not unusual for stool to appear paler in colour than normal as a result of local contact with sterculia, as contained in NORMACOL. This does not indicate anything untoward. If patients notice a sudden change in bowel habits that has persisted for a period of longer than two weeks, they should consult a doctor before using NORMACOL. Frequent and prolonged use of NORMACOL may result in dependence on laxatives and loss of normal bowel function. Rectal bleeding or failure to have a bowel movement after the use of a laxative, such as NORMACOL, may indicate a serious condition. Patients should discontinue the use of NORMACOL and consult a doctor.

NORMACOL should not be taken for more than 4 days if there has been no movement of the bowels. Caution should be exercised in cases of ulcerative colitis.

Obstruction is possible if NORMACOL is taken in overdose or is not adequately washed down with fluids.

Excipients

Sucrose: NORMACOL contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Sodium: NORMACOL contains approximately 17 mg sodium in each 5 mL spoon of NORMACOL granules that is to say essentially u2018sodium - freeu2019. The WHO recommended maximum daily intake of sodium for an adult is 2 grams.

NORMACOL lowers the transit time through the gut and could interfere with the absorption of other medicines.

Safe for use in pregnancy and lactation.

Fertility: There is no fertility data.

NORMACOL has none or negligible influence on the ability to drive and use machines.

a) Tabulated list of adverse reactions

System organ class

Less frequent

Immune system disorders

Allergic reactions

Gastrointestinal disorders

Oesophageal obstruction, intestinal/colonic obstruction or impaction, abdominal distension, flatulence, diarrhoea, nausea, abdominal pain

Skin and subcutaneous tissue disorders

Urticaria

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to: SAHPRA: https://www.sahpra.org.za/health-products-vigilance/

Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088

Symptoms: Intestinal obstruction is possible in overdosage particularly in combination with inadequate fluid intake.

Management: Management is as for intestinal obstruction from other causes. If there is profound diarrhoea, dehydration and electrolyte depletion may occur. Treatment is supportive and symptomatic.