Duphalac Adverse Reactions

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 a 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.
Hypersensitivity reactions mainly limited to the skin have been observed and identified as potential adverse reactions during post approval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.*
Tabulated list of adverse reactions: The following undesirable effects have been experienced with the frequencies indicated as follows 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)] or have been reported spontaneously during post approval use [frequency not known (a precise frequency cannot be estimated from the available data)]. (See Table 2.)

Click on icon to see table/diagram/image

Pediatric population: The safety profile in children is expected to be similar as in adults.
For bowel cleansing in preparation for colonoscopy (adults): Diarrhea is an expected outcome of bowel preparation. Due to the nature of the intervention, undesirable effects occur during the process of bowel preparation. Nausea, vomiting, abdominal distension, abdominal pain has been observed in patients undergoing bowel preparation, and these undesirable effects were also observed in the clinical studies with lactulose for bowel preparation. Undesirable effect data were actively elicited in clinical studies regarding lactulose for bowel preparation. The mainly observed undesirable effects are gastrointestinal in nature.