COMPOUND MACROGOL

Posology Chronic constipation A course of treatment for constipation with Compound Macrogol 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 –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.

Paediatric population Children (below 12 years old):

Not recommended. 86 g product is available for children. Faecal impaction A course of treatment for faecal impaction with Macrogol 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.

Paediatric population Children (below 12 years old):

Not recommended. 86 g product is 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 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) Compound Macrogol should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately. g. the elderly, patients with impaired hepatic or renal function or patients taking diuretics) and electrolyte control should be considered.

5). 230) of potassium per sachet. This should be taken into consideration if the patient takes more than one sachet daily and has reduced kidney function or is on a controlled potassium diet. 72 g, powder for oral solution in children, therefore it should not be used in children below 12 years of age.

87 mg sodium (main component of cooking/table salt) per sachet. 3% of the recommended maximum daily dietary intake of sodium for an adult. 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. Compound Macrogol may result in a potential interactive effect when used with starch-based food thickeners. The polyethylene glycol (PEG) 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 Compound Macrogol in pregnant women. 3). Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible.

Compound Macrogol 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. Compound Macrogol can be used during breast-feeding.

The fluid content of Compound Macrogol when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. Avoid mixing PEG laxatives and starch-based thickeners in patients with dysphagia, considered at risk of aspiration.

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) Compound Macrogol should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately.

g. the elderly, patients with impaired hepatic or renal function or patients taking diuretics) and electrolyte control should be considered. 5). 230) of potassium per sachet. This should be taken into consideration if the patient takes more than one sachet daily and has reduced kidney function or is on a controlled potassium diet.

72 g, powder for oral solution in children, therefore it should not be used in children below 12 years of age. 87 mg sodium (main component of cooking/table salt) per sachet. 3% of the recommended maximum daily dietary intake of sodium for an adult.

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.