MOVICOL PLAIN

Chronic Constipation A course of treatment for constipation with Movicol Plain does not normally exceed two 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: 1-3 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 Plain 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 two sachets are taken in any one hour.

Patients with renal insufficiency:

No dosage change is necessary for treatment of either constipation or faecal impaction. Method of administration Each sachet should be dissolved in 125ml water. For use in faecal impaction 8 sachets may be dissolved in 1 litre water.

8. g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Movicol Plain should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately. 5). 3% of the WHO recommended maximum daily intake for sodium.

When used long term for constipation, the maximum daily dose of this product is equivalent to 28% of the WHO recommended maximum daily intake for sodium. Movicol Plain is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

5. 5 Interaction with other medicinal products and other forms of interaction Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water. 4). g. anti-epileptics. Therefore, other medicines should not be taken orally for one hour before, during and for one hour after taking Movicol Plain.

Movicol Plain may result in a potential interactive effect if used with starch-based food thickeners. The Macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.

6 Fertility, Pregnancy and lactation Pregnancy There are limited amount of data from the use of Movicol in pregnant women. 3). Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible.

Movicol can be used during pregnancy. Breastfeeding No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Macrogol 3350 is negligible. Movicol can be used during breast-feeding.

Fertility There are no data on the effects of Movicol on fertility in humans. 3). 7 Effects on ability to drive and use machines Movicol Plain has no influence on the ability to drive and use machines. 8 Undesirable effects Reactions related to the gastrointestinal tract occur most commonly.

The fluid content of Movicol Plain when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.

8. g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Movicol Plain should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately. 5). 3% of the WHO recommended maximum daily intake for sodium.

When used long term for constipation, the maximum daily dose of this product is equivalent to 28% of the WHO recommended maximum daily intake for sodium. Movicol Plain is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

5.

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.