Lactulose

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible.

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to lactulose is negligible.

Lactulose has no or negligible influence on the ability to drive and use machines.

A normal dosage of lactulose may cause mild abdominal pain and flatulence which will disappear spontaneously after a few days. High doses may provoke nausea in some patients and this can be minimised by administration with water, fruit juice or meals. Administration of higher doses than those instructed can result in abdominal pain and diarrhoea, in this instance the dose should be decreased.

If high doses (such as those associated with the treatment of portosystemic encephalopathy) are used for extended periods of time, the patient may experience an electrolyte imbalance due to diarrhoea. The dose should be adjusted to obtain two to three formed stools per day.

List of adverse events

The following undesirable effects have been experienced with the below indicated frequencies in lactulose-treated patients: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).

Gastrointestinal disorders

Very common: Diarrhoea

Common: Flatulence, abdominal pain, nausea, vomiting

Investigations

Uncommon: Electrolyte imbalance due to diarrhoea

Paediatric population

The safety profile in children is expected to be similar as in adults.