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2. Macrogol 3350 (Polyethylene Glycol 3350) 13.125 g
4.1 ………….loading of the rectum and/or colon. confirmed by physical examination of the abdomen and rectum.
4.2 Children below 12 years old: Not recommended. Alternative Movicol products are available for children.
4.3 Known hypersensitivity to any of these active substances or to any of the excipients. Hypersensitivity to the active ingredients or to any of the excipients.
4.4 Special warnings and precaustions for use
Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.
There is no clinical trial data on the use of Movicol in children, therefore it is not recommended.
4.5 Macrogol raises the solubility of drugs medicinal products that are soluble in alcohol and relatively insoluble in water. There is therefore a theoretical possibility that the absorption of such drugs medicinal products could be transiently reduced.
4.7 There is no effect Movicol has no influence on the ability to drive and use machines.
5.1 Pharmacotherapeutic group: Osmotically acting laxatives.
6.1 List of Excipients
Acesulfame K potassium (E950)
Lime and lemon flavour*
(Lime and lemon flavour contains the following constituents: acacia solids, maltodextrin, lime oil, lemon oil, citral, citric acid and water).
6.3 Shelf Life
The shelf life of the sachets is 3 years.
Discard any solution not used within Reconstituted solution: 6 hours.
6.4 Reconstituted solution: Store at 2 - 8°C (in a refrigerator and covered).
6.5 Nature and contents of container Sachet: laminate consisting of four layers: low density polyethylene, aluminium, low density polyethylene and paper.
13.8g sachets contained in Pack sizes: boxes of 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
None. Any unused solution should be discarded within 6 hours.
10 Date of revision of the text
August 2002 August 2005 August 2006 March 2007
Section 5.1:
Macrogol 3350 acts by virtue of its osmotic action in the gut, which induces a laxative effect. . . Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of the defaecation. Electrolytes combined with macrogol 3350 are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted in faecal water without net gain or loss of sodium, potassium and water.
Section 5.2:
Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the gastro-intestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.