Summary of the safety profile: The most frequently occurring adverse reactions were all in the gastrointestinal disorders system organ class. Most of these adverse reactions were mild to moderate in intensity.
Tabulated list of adverse reactions: Adverse reactions that occurred are listed by frequency in the table as follows. The reporting rate is classified as very common, common, uncommon, rare, very rare, not known. (See Table 3.)
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Paediatric population: In general, the safety profile for children and adolescents (6 to 18 years of age) is similar to the safety profile for adults.