The administration of Hidrasec 175mg does not modify the usual rehydration regimens and dietary measures. 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 assessed in antibiotic-associated diarrhoea, therefore racecadotril should not be administered under these conditions Chronic diarrhoea has not been sufficiently studied with this medicinal product. There is a possible reduced bioavailability in patients with prolonged vomiting.
Renal and hepatic impairment:
There are limited data in patients with renal or hepatic impairment. 2). 4 mmol) of lactose anhydrous. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Hypersensitivity:
Occurrence of skin reactions has been reported with the use of the product. In most cases, these are mild and do not require treatment. However, 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.
Racecadotril should not be reintroduced.
Bradykinin angioedema:
Racecadotril or some therapeutic classes are likely to cause a vascular reaction such as angioedema of the face and neck, resulting from the inhibition of the degradation of bradykinin. The outcomes of angioedema can sometimes be fatal, due to airway obstruction.
Angioedema can occur independently of a simultaneous association between these medicines if the patient has been previously exposed to one of the two protagonists. It will be necessary to search for the history of the occurrence of this effect and to determine the need for this type of association.
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Severe cutaneous adverse reactions (SCARs):
Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in association with racecadotril treatment. Patients should be advised of the signs and symptoms and monitored closely for skin reactions.