LAX-TAB Gastro-resistant tablet Ref.[50289] Active ingredients: Bisacodyl

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Lax-Tab 5 mg gastro-resistant tablets.

Pharmaceutical Form

Gastro-resistant tablet.

Light yellow, round, gastro-resistant tablets.

Qualitative and quantitative composition

Each gastro-resistant tablet contains 5 mg bisacodyl.

Excipient(s) with known effect: This product contains 26.3 mg lactose and 35.396 mg sucrose.

For the 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

Core:

Lactose monohydrate
Maize starch
Povidone
Cellulose, microcrystalline
Sodium starch glycolate (type A)
Silica, colloidal anhydrous
Magnesium stearate
Talc

Coating:

Methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30%
Macrogol 6000
Talc
Silicon antifoam
Gelatin
Povidone
Sucrose
Calcium carbonate
Quinoline yellow E104

Pack sizes and marketing

PVC/Aluminium blisters. Pack-sizes of 30, 50, 100 and 1000 gastro-resistant tablets.

PP containers with PE closure. Pack-sizes of 50 and 1000 gastro-resistant tablets.

Not all pack-sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

19734

Date of first authorization: 08 November 2005
Date of latest renewal: 12 September 2011

Drugs

Drug Countries
LAX-TAB Australia, Cyprus, Malta, New Zealand

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