Summary of the safety profile: Flatulence may occur during the first few days of treatment. As a rule, it disappears after a few days. When dosages higher than instructed are used, abdominal pain and diarrhea may occur. In such case the dosage should be decreased.
If high doses (normally only associated with, hepatic encephalopathy, HE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhea.
Tabulated list of adverse reactions: The following undesirable effects have been experienced with the following indicated frequencies in lactulose-treated patients in placebo-controlled clinical trials [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)]. (See Table 2.)
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Paediatric population: The safety profile in children is expected to be similar as in adults.