MACROLYTE

Posology Chronic constipation A course of treatment for constipation with Macrolyte 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 older people: 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. Faecal impaction A course of treatment for faecal impaction with Macrolyte does not normally exceed 3 days. Adults, adolescents and older people: 8 sachets daily, all of which should be consumed within a 6 hour period.

Children below 12 years old:

Not recommended.

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. 4 for warning about excipients). Method of 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.

8. g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Macrolyte 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.

The maximum daily dose of this product when used long term for constipation is equivalent to 28% of the WHO recommended maximum daily intake for sodium. Macrolyte 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 Macrolyte.

Macrolyte 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 Macrolyte in pregnant women. 3). Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible.

Macrolyte 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. Macrolyte can be used during breast-feeding.

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

The fluid content of Macrolyte 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) Macrolyte 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.

The maximum daily dose of this product when used long term for constipation is equivalent to 28% of the WHO recommended maximum daily intake for sodium. Macrolyte 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. 1.