Smecta/SmectaGo/Smecta Strawberry Adverse Reactions

Smecta: The following adverse effects have been reported during clinical trials carried out with children and adults. These adverse effects have usually been minor and temporary and were mainly related to the digestive system.
The frequencies of adverse events have been classified as follows: frequent (≥1/100, <1/10), infrequent (≥1/1,000, ≤1/100).
Gastrointestinal problems: Frequent: Constipation usually resulting with the reduction of the dose, but which, in rare cases, may result in the treatment being stopped.
Infrequent: Flatulence, vomiting.
During post-marketing experience, cases of hypersensitive reactions (unknown frequency), comprising urticarial, rashes, pruritus and angioedema have been reported. Cases of aggravation of the constipation have also been reported.
SmectaGo/Smecta Strawberry: The most commonly reported adverse reaction during treatment is constipation, occurring in approximately 7% of adults and 1% of children. If constipation occurs, treatment with dioctahedral smectite should be discontinued, and then re-started at a lower dose if necessary.
The following table lists adverse drug reactions reported from clinical studies and post-marketing surveillance. Their frequencies are defined according to the following convention: 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). Frequency is estimated from rates of occurrence observed in the clinical studies. (See table.)

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Reporting/Declaration of suspected adverse events: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.