Sterculia

Product: UK SPC via MHRA Products - NORMACOL (PL003225010), Norgine Limited; §2 (verbatim): 'The active ingredient is Sterculia BP 62% w/w'. The retrieved §2 does not print the sterculia weight per sachet or per 5 ml spoonful, so no per-unit gram figure is stated. §4.1 (verbatim): '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.' COVERAGE: this SPC covers Normacol granules only; other sterculia-containing products differ and are not covered. VERBATIM §4.2: 'Adults: 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals. Older people: As adult dose.' METHOD (§4.2): '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.' The SPC prints no maximum dose and no renal or hepatic adjustment, so none is given. KEY WARNINGS (§4.4): 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; take with plenty of water to reduce the risk of oesophageal obstruction and maintain adequate fluid intake; caution in ulcerative colitis; stool may appear paler than normal as a result of local contact with sterculia, which 'does not indicate anything untoward'; each dose contains 28.7 mg sodium; patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take it. The old openFDA record in this bundle (a topical 'Stretch Marks cream') was not used.

THIS IS THE LABEL'S OWN INSTRUCTION (SPC §4.2: 'Children: (6-12 years): one half the above amount'), expressed as a fraction of the adult amount; no per-kg or gram figure is printed and none is added. SPC §4.2: 'NORMACOL is not recommended for children under 6 years of age' - no dose is given for under-6s, and none for neonates.