Hidrasec Special Precautions

The administration of Hidrasec/Hidrasec Paediatric does not modify the usual rehydration regimens.
Hidrasec Paediatric: Rehydration is highly important in the management of acute diarrhoea in infants. The requirement for rehydration and route should be adapted to the age and weight of the patient and the stage and severity of the condition, specifically in case of serious or prolonged diarrhoea with significant vomiting or a lack of appetite. Additionally, it is important that regular feeding (incl. breastfeeding) is not interrupted and that adequate fluid intake is monitored.
Hidrasec/Hidrasec Paediatric: 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, warranting casual (e.g. antibiotic) treatment or further investigation. Therefore, racecadotril should not be administered under these conditions. Racecadotril may be given concomitantly with antibiotics in case of acute diarrhoea with a bacterial cause as a complementary treatment.
Use of racecadotril in antibiotic-associated diarrhoea and chronic diarrhoea is not recommended due to insufficient data.
Hidrasec: There are limited data in patients with renal or hepatic impairment. These patients should be treated with caution (see Pharmacology: Pharmacokinetics under Actions).
These is a possible reduced availability in patients with prolonged vomiting.
Hidrasec Paediatric: In patients with diabetes, it should be taken into account that each sachet contains: HIDRASEC Paediatric 10 mg: 0.966 g of sucrose; HIDRASEC Paediatric 30 mg: 2.899 g of sucrose.
If the quantity of sucrose (source of glucose and fructose) present in the daily dose of HIDRASEC Paediatric exceeds 5 g a day, the latter should be taken into account in the daily sugar ration.
The product must not be administered to infants less than 3 months old, as there are no clinical trials in this population.
The product must not be administered to children with renal or liver impairment, whatever the degree of severity, due to lack of information on these patient populations.
Because of possible reduced bioavailability, the product must not be administered in cases of prolonged or uncontrolled vomiting.
Effects on ability to drive and use machines: Racecadotril has no or negligible influence on the ability to drive and use machines.