The administration of Hidrasec do not modify the usual rehydration regimens. It is essential for the child to drink abundant liquids.
In the event of serious or prolonged diarrhoea with important vomiting or a lack of appetite, IV rehydration should be considered.
The presence of bloody or purulent stools and fever may indicate the presence of invasive bacteria as a reason for diarrhoea, or the presence of other severe disease. Also, racecadotril has not been tested in antibiotic-associated diarrhoea. Therefore, racecadotril should not be administered under these conditions.
Chronic diarrhoea has not been sufficiently studied with Hidrasec.
Hidrasec must not be administered in patients with renal or liver impairment (see Pharmacology: Pharmacokinetics under Actions), whatever the degree of severity, due to a lack of information on these patient populations.
Hepatic or Renal Impairment: There are no studies in infants or children with renal or hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Because of possible reduced bioavailability, the product must not be administered in cases of prolonged or uncontrolled vomiting.
In patients with diabetes, it should be taken into account that each sachet contains sucrose 0.966 g (Hidrasec Infants) and 2.899 g (Hidrasec Children). If the quantity of sucrose (source of glucose and fructose) present in the daily dose of Hidrasec Infants and Hidrasec Children exceeds 5 g daily, the latter should be taken into account in the daily sugar ration.
Hidrasec must not be administered to infants <3 months, as there are no clinical trials in this population.
Effects on the Ability to Drive or Operate Machinery: Racecadotril has no or negligible influence on the ability to drive and use machines.
Fertility: Fertility studies conducted with racecadotril on rats demonstrate no impact on fertility.
Use in pregnancy & lactation: There are no adequate data from the use of racecadotril in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, fertility, embryo-foetal development, parturition or postnatal development. However, since no specific clinical studies are available, racecadotril should not be administered to pregnant women.
There is insufficient information on the excretion of racecadotril in human milk; Hidrasec should not be administered to breastfeeding women.