Therapeutic indications
For the treatment of chronic constipation.  MOVICOL is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon.

Posology and method of administration
Chronic constipation

A course of treatment for constipation with MOVICOL does not normally exceed 2 weeks, although this can be repeated if required.

As for all laxatives, prolonged use is not usually recommended.  Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson's Disease, or induced by regular constipating medication in particular opioids and antimuscarinics.

Adults, adolescents and the elderly: 1 to 3 sachets daily in divided doses, according to individual response.

For extended use, the dose can be adjusted down to 1 or 2 sachets daily.

Children below 12 years old: Not recommended.  Alternative MOVICOL products are available for children.


Faecal impaction

A course of treatment for faecal impaction with MOVICOL does not normally exceed 3 days.

Adults, adolescents and the elderly: 8 sachets daily, all of which should be consumed within a 6 hour period.

Children below 12 years old: Not recommended.  Alternative MOVICOL products are available for children.

Patients with impaired cardiovascular function: For the treatment of faecal impaction the dose should be divided so that no more than 2 sachets are taken in any one hour.

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


Administration

Each sachet should be dissolved in 125 ml water.  For use in faecal impaction 8 sachets may be dissolved in 1 litre of water.


Contraindications
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 ingredients or to any of the excipients.


Special warnings and precautions for use
Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.

Mild adverse drug reactions are possible as indicated in Section 4.8.  If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g.  oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) MOVICOL should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately.


Interaction with other medicinal products and other forms of interaction
No clinical interactions with other medicinal products have been reported.  Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water.  There is therefore a theoretical possibility that the absorption of such medicinal products could be transiently reduced.