Hidrasec Warnings

Granules for oral suspension: Chronic diarrhoea has not been sufficiently studied with Hidrasec Infants.
In patients with diabetes, it should be taken into account that each sachet contains: 0.9665 g of sucrose (Hidrasec Infants) or 2.8995 g of sucrose (Hidrasec Children).
If the quantity of sucrose (source of glucose and fructose) present in the daily dose of Hidrasec Infants 10 mg or 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 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.
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/Angioneurotic Oedema have been reported in patients with racecadotril. This may occur at any time during therapy.
Angioedema of the face, extremities, lips, mucous membranes may occur.
Where there is angioedema associated with upper airway obstruction, such as tongue, glottis and/or larynx, emergency therapy should be administered promptly.
Racecadotril should be discontinued and the patient should be under close medical supervision with appropriate monitoring initiated and continued until complete and sustained resolution of symptoms has occurred.
Patients with a history of angioedema unrelated to racecadotril therapy may be at increased risk of angioedema.
Concomitant use of racecadotril and ACE inhibitors may increase the risk of angioedema (see Interactions). Hence, a careful benefit-risk assessment is needed before initiating treatment with racecadotril in patients on ACE inhibitors.