COMPOUND MACROGOL VALE

Posology 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.

Children (below 12 years old):

Not recommended. Alternative macrogol products are available for children. Method of administration Compound Macrogol is for oral use. Each sachet should be dissolved in 125 ml 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. 5). The lemon lime flavour in Compound Macrogol contains sorbitol.

Patients with rare hereditary problems of fructose intolerance should not take this medicine. 5 Interaction with other medicinal products and other forms of interaction Macrogol 3350 raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water.

4). g. antiepileptics. 6 Fertility, pregnancy and lactation Pregnancy There are limited amount of data from the use of macrogol 3350 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. Breast-feeding No effects on the breast-fed 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.

Fertility There are no data on the effects of macrogol 3350 on fertility in humans. 3). 7 Effects on ability to drive and use machines Macrogol 3350 has no influence on the ability to drive and use machines. 8 Undesirable effects Reactions related to the gastrointestinal tract occur most commonly.

These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of macrogol 3350. Mild diarrhoea usually responds to dose reduction.

The frequency of the adverse effects is not known as it cannot be estimated from the available data. System Order Class Adverse Event Immune system disorder Allergic reactions, including anaphylaxis, angioedema, dyspnoea, rash, urticaria, and pruritus.

Skin and subcutaneous tissue disorders Erythema Metabolism and nutrition disorders Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia. Nervous system disorders Headache Gastrointestinal disorders Abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence and anorectal discomfort.

General disorders and administration site conditions Peripheral oedema. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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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. 5). The lemon lime flavour in Compound Macrogol contains sorbitol.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

1. 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.