Hidrasec Special Precautions

Precautions for use: Administration of racecadotril does not modify the usual rehydration regimens.
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 causal (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.
Granules for oral suspension: 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.
In patients with diabetes, it should be taken into account that each sachet contains: HIDRASEC INFANTS 10mg: 0.966g of sucrose.
HIDRASEC CHILDREN 30mg: 2.899g of sucrose.
If the quantity of sucrose (source of glucose and fructose) present in the daily dose of HIDRASEC INFANT 10mg and HIDRASEC CHILDREN 30 mg 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 a 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.
Capsule: There are limited data in patients with renal or hepatic impairment. These patients should be treated with caution (see Pharmacology: Pharmacokinetics under Actions).
There is a possible reduced availability in patients with prolonged vomiting.
Warnings: Occurrence of skin reactions has been reported with the use of the product. These are in most cases mild and do not require treatment but in some cases they can be severe, even life-threatening.
Association with racecadotril cannot be fully excluded. When experiencing severe skin reactions, the treatment has to be stopped immediately.
Hypersensitivity/Angioedema have been reported in patients with racecadotril. This may occur at any time during therapy. Patients with a history of angioedema unrelated to racecadotril therapy may be at increased risk of angioedema.
Capsule:This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on ability to drive and use machines: Racecadotril has no or negligible influence on the ability to drive and use machines.