Hidrasec Adverse Reactions

Capsule: Clinical studies conducted on acute diarrhoea have provided data in 2193 adult patients treated with racecadotril and 282 treated with placebo.
The adverse reactions listed as follows have been observed more frequently with racecadotril than with placebo during clinical trials, or have been reported during marketing phase.
The frequency of adverse reactions has been 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), not known (cannot be estimated from the available data).
Central nervous system disorders: Common: Headache.
Skin and subcutaneous tissue disorders: Uncommon: Rash, erythema.
Not known: Erythema multiforme, oedema of the tongue, face, lips or eyelids, angioedema (Quincke's oedema), urticaria, erythema nodosum, papular rash, pruritus, prurigo, toxidermia.
Granules for oral suspension: Data from clinical acute diarrhoea studies are available for 860 paediatric patients treated with racecadotril, and 441 treated with placebo.
The following adverse drug reactions listed as follows have occurred with racecadotril more often than with placebo or have been reported during post-marketing surveillance.
The frequency of adverse reactions is defined using 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), not known (cannot be estimated from the available data).
Infections and infestations: Uncommon: Tonsillitis.
Skin and subcutaneous tissue disorders (see Warnings): Uncommon: Rash, erythema.
Unknown: Erythema multiforme, tongue oedema, face oedema, lip oedema, eyelid oedema, angioedema, urticaria, erythema nodosum, rash papular, prurigo, pruritus.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report all suspected adverse reactions to Drug Office, Department of Health.