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Adverse Drug Reactions are listed under headings of frequency using the following categories: 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), unknown (cannot be estimated from the available data). (See Table 1.)
Click on icon to see table/diagram/imageIn adults, the following additional undesirable effects have been observed in clinical trials and post-marketing use: Gastro-intestinal disorders: Uncommon: Urgency to defecate, fecal incontinence.
Metabolism and nutrition disorders: Unknown: electrolytes disorders (hyponatremia, hypokalaemia) and or dehydration, especially in elderly patients.
Immune system disorders: Unknown: Erythema.
10 g: Adverse Drug Reactions are listed under headings of frequency using the following categories : 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); not known (cannot be estimated from the available data).
Adult population: The undesirable effects listed in the table as follows have been reported during clinical trials (including 600 adult patients) and post-marketing use. Generally, adverse reactions have been minor and transitory and have mainly concerned the gastrointestinal system: (See Table 2.)
Click on icon to see table/diagram/imagePaediatric population: The undesirable effects listed in the table as follows have been reported during clinical trials including 147 children aged from 6 months to 15 years and post-marketing use. As in adult population, adverse reactions have generally been minor and transitory and have mainly concerned the gastrointestinal system: (See Table 3.)
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