Polyethylene Glycol 3350 + Electrolytes

For use in adults and children over 12 years of age for effective relief from constipation and treatment of chronic constipation. Also effective in resolving fecal impaction, defined as refractory constipation with fecal loading of the rectum and colon.

Macrogol, also known as polyethylene glycol exerts an osmotic action in the gut, which induces a laxative effect. Macrogol increases stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the soften stools and a facilitation of the defecation. Electrolytes combined with Macrogol are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted without net gain or loss of sodium, potassium and water. Macrogol is unchanged along the gut. It is virtually unabsorbed from the gastrointestinal tract.

For adults and children aged 12 years and above : (Powder for Suspension)

Constipation : The dose is 1 sachet daily. This may be increased to 2-3 sachets daily, if required.

Fecal Impaction : 8 sachets daily, consumed within 6 hours. A course of treatment for fecal impaction does not normally exceed 3 days.

Patients with renal insufficiency : No dosage change is necessary for treatment of either constipation or fecal impaction.

Direction of use : Each sachet should be dissolved in 125 ml water. For fecal impaction 8 sachets may be dissolved in 1 litre of water. Store the solution refrigerated and discard any solution not used within 6 hours.

For adults and children aged 12 years and above : (Oral Solution)

Constipation : 25 ml of Polyethylene Glycol 3350 and electrolytes oral solution added to 100 ml of water once daily (to make a total volume of 125 ml). This may be increased to 2-3 doses of 25 ml daily (each 25 ml dose added to 100 ml of water), if required according to individual response.

Fecal Impaction : 8 doses of 25 ml daily (each 25 ml dose added to 100 ml of water). A course of treatment for fecal impaction does not normally exceed 3 days.

Direction of use : 25 ml of oral solution added to 100 ml of water (to make a total volume of 125 ml). Any unused diluted solution should be discarded within 24 hours.

There is a possibility that the absorption of other medicinal products could be transiently reduced during use with Movilax. There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis and toxic megacolon. Hypersensitivity to the active substances.

Generally well tolerated. However side effects like allergic reactions, electrolyte disturbances particularly hyperkalaemia and hypokalaemia, abdominal pain, diarrhea, headache, peripheral edema may appear.

Clinically, no effects during pregnancy are anticipated, since systemic exposure to Macrogol (3350) is negligible. This oral solution can be used during pregnancy. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Macrogol (3350) is negligible. This oral solution can be used during breastfeeding.

Patients with impaired cardiovascular function : For the treatment of fecal impaction the dose should be divided so that no more than two sachets are taken in any one hour. If patients develop any symptoms indicating shifts of fluid/electrolytes (e.g. edema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Movilax should be stopped immediately and any abnormality should be treated appropriately. Prolonged use with all laxatives is undesirable and may lead to dependence.

Severe pain or distention can be treated by nasogastric aspiration. Extensive fluid loss by diarrhea or vomiting may require correction of electrolyte disturbances.

Store below 30° C and in a place protected from light. Do not refrigerate.