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DULCOLAX Gastro-resistant tablets (2017)

Active ingredients: Bisacodyl

Product Name and Form

DULCOLAX 5 mg Gastro-resistant Tablets.

Pharmaceutical form

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.

Chemical substance
Description
Bisacodyl

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.

List of excipients

Tablet core:

Lactose
Maize starch
Soluble maize starch
Glycerol
Magnesium stearate

Tablet coating:

Magnesium stearate
Sucrose
Talc
Acacia
Titanium dioxide (E171)
Methacrylic acid-methylmethacrylate copolymer (1:1)
Methacrylic acid-methylmethacrylate copolymer (1:2)
Castor oil
Macrogol 6000
Yellow iron oxide (E172)
White beeswax
Carnauba wax
Shellac

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.

Marketing authorization holder
Authorization dates

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

Marketing authorization number:

PL 04425/0718