TOILAX MICRO ENEMA Rectal suspension Ref.[50433] Active ingredients: Bisacodyl

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Product name and form

Toilax Micro Enema 10 mg/5 ml Rectal Suspension.

Pharmaceutical Form

Rectal suspension (enema).

Disposable yellow enema applicator tube with elongated tube nozzle containing a white/grey ointment like preparation.

Qualitative and quantitative composition

Bisacody.

Each micro-enema contains 2mg/ml of bisacodyl.

For a full list of excipients, see section 6.1

Active Ingredient 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

Macrogol 3000
Macrogol 4000
Macrogol 400
Citric acid monohydrate
Sodium citrate
Purified water

Pack sizes and marketing

Disposable enema applicator tube with elongated tube nozzle containing 5 ml suspension packed as 5 or 50 single-use 5ml plastic enemas in a cardboard outer container.

Marketing authorization holder

Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Marketing authorization dates and numbers

PA1327/007/001

Date of first authorisation: 21 January 1981
Date of last renewal: 21 January 2006

Drugs

Drug Countries
TOILAX MICRO ENEMA Finland, Ireland

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