Hidrasec Adverse Reactions

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).
Capsule: Clinical studies conducted on acute diarrhoea have provided data in 2193 adult patients treated with racecadotril and 282 treated with placebo.
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: Clinical studies conducted on acute diarrhoea have provided safety-in-use data in 860 infants and children treated with racecadotril and 441 treated with placebo.
Skin and subcutaneous tissue disorders: Uncommon: rash, erythema.
Not known: urticaria, angioedema, oedema of the tongue, face, lip or eyelids, erythema multiforme, erythema nodosum, papular rash, pruritus, prurigo.
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. Website: http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/adr_reporting.