Duphalac Adverse Reactions

Like all medicines, Duphalac oral solution may cause side effects, although not everyone experiences them.
If the patient notices any side effects not mentioned in the monograph, or if any of the side effects gets serious, inform the doctor or pharmacist.
Summary of the safety profile: Flatulence may occur during the first few days of treatment. As a rule, it disappears after a few days.
Diarrhoea and abdominal pain may be experienced if the patient takes a higher dose than instructed. If this occurs, the dosage should be decreased to reflect the recommended dosage (see Overdosage).
If the patient is taking a high dose (normally only with hepatic encephalopathy HE) for an extended period of time, the patient may experience an electrolyte imbalance (not enough electrolytes in the blood) due to diarrhea.
Hypersensitivity reactions mainly limited to the skin have been observed and identified as potential adverse reactions during postapproval 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 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) or have been reported spontaneously during postapproval use [frequency not known (a precise frequency cannot be estimated from the available data)]. (See Table 2.)

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