DULCOLAX Gastro-resistant tablets (2017)
Active ingredients: Bisacodyl
Product Name and Form
DULCOLAX 5 mg Gastro-resistant Tablets.
Gastro-resistant tablets for oral administration.
Circular, biconvex, yellow, sugar-coated and enteric-coated tablet.
Qualitative and Quantitative Composition
Each tablet contains Bisacodyl 5mg.
For excipients, see 6.1.
Bisacodyl is a locally acting laxative from the diphenylmethane derivatives group having a dual action. As a contact laxative, for which also antiresorptive hydragogue effects have been described, bisacodyl stimulates after hydrolysis in the large intestine, the mucosa of both the large intestine and of the rectum. Stimulation of the mucosa of the large intestine results in colonic peristalsis with promotion of accumulation of water, and consequently electrolytes, in the colonic lumen. This results in a stimulation of defecation, reduction of transit time and softening of the stool. Stimulation of the rectum causes increased motility and a feeling of rectal fullness. The rectal effect may help to restore the “call to stool” although its clinical relevance remains to be established.
Soluble maize starch
Titanium dioxide (E171)
Methacrylic acid-methylmethacrylate copolymer (1:1)
Methacrylic acid-methylmethacrylate copolymer (1:2)
Yellow iron oxide (E172)
Pack sizes and Marketing
Blister packs consisting of opaque white PVC/PVDC blister foil and aluminium foil (covering foil).
Blister packs consisting of colourless PVC blister foil and aluminium foil (covering foil).
Packs of 6, 8, 10, 20, 30, 40 and 60.
Not all pack sizes may be marketed.
Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom
Trading as: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom
01 June 1992 / 25 February 2005