Hidrasec Special Precautions

The concomitant used of racecadotril and angiotensin-converting enzyme (ACE) inhibitors may increase the risk of angioedema (see Interactions). Consequently, rigorous evaluation of the benefit/risk balance is required before introducing racecadotril treatment in patients receiving angiotensin-converting enzyme inhibitors.
Capsule: Hidrasec is not substitute for rehydration, if required.
Racecadotril must not be used if signs of acute dysenteric syndrome are present, such as bloody stools or fever.
Racecadotril has not been evaluated and must not be used in antibiotic-related diarrhoea.
There is insufficient data regarding chronic diarrhoea and this medicinal product.
Data are limited in patients with renal or hepatic insufficiency. Caution should therefore be exercised when treating these patients (see Pharmacology: Pharmacokinetics under Actions).
Bioavailability may be reduced in patients with prolonged vomiting.
This medicinal product contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases).
Skin reaction have been reported with the use of this medicinal product. In most cases, these reactions are mild and do not require any treatment. However, in certain situations, these reactions may be severe and life-threatening; the link with taking racecadotril cannot be ruled out entirely. If severe skin reaction appear, treatment with racecadotril must be discontinued immediately.
Cases of hypersensitivity and Quincke's oedema have been reported in patients treated with racecadotril. These events may occur at any time during treatment. Angioedema of the face, extremities, lips and mucosa may develop.
Emergency treatment must be administered immediately if angioedema is associated with obstruction of the upper airways involving the tongue, glottis and/or larynx, for instance.
Racecadotril must be discontinued and the patient subjected to strict medical monitoring with the introduction of appropriate follow-up until these symptoms have completely regressed in the long term.
Patients with a history of angioedema not associated with racecadotril treatment may be at increased risk of developing angioedema.
Granules for oral suspension: Treatment with Hidrasec is merely an adjuvant therapy in addition to oral rehydration and does not in any way substitute it. Rehydration must be systematic in infants/children with acute diarrhoea to prevent or treat dehydration and must be adapted in such a way as to compensate for fluid and electrolyte losses.
Treatment of acute diarrhea in children is primarily based on correcting fluid and electrolyte losses, by using oral rehydration solutions and re-establishing feeding patterns as soon as possible, depending on the child's age and dietary habits prior to diarrhoea.
In cases of severe or prolonged diarrhoea, significant vomiting or refusal of food, intravenous rehydration must be envisaged.
The presence of blood or pus in the stools with fever can be a sign of diarrhoea due to invasive germs or indicate the presence of other ongoing diseases. In the case of infectious diarrhoea with clinical signs suggestion an invasive phenomenon, use antibacterial agents with good systemic diffusion. Racecadotril has not been evaluated in antibiotic-related diarrhoea. Hence, racecadotril must not be used in these cases.
Due to potentially reduced bioavailability, racecadotril must not be administered in cases of prolonged or uncontrollable vomiting.
In cases of renal or hepatic insufficiency, Hidrasec must not be administered due to lack of data.
This medicinal product contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency.
Each sachet contains: Hidrasec Infants: 0.9665 g of sucrose; Hidrasec Children: 2.8995 g of sucrose.
If the quantity of sucrose (source of glucose or fructose) in the daily dose of this medicine exceeds 5 g per day, this must be taken into account in the daily allowance of patients on slow-sugar diet or with diabetes.
Skin reaction have been reported with the use of this medicinal product. In most cases, these reactions are mild and do not require any treatment. However, in certain situations, these reactions may be severe and life-threatening; the link with taking racecadotril cannot be ruled out entirely. If severe skin reaction appear, treatment with racecadotril must be discontinued immediately.
Cases of hypersensitivity and Quincke's oedema have been reported in patients treated with racecadotril. These events may occur at any time during treatment. Angioedema of the face, extremities, lips and mucosa may develop.
Emergency treatment must be administered immediately if angioedema is associated with obstruction of the upper airways involving the tongue, glottis and/or larynx, for instance.
Racecadotril must be discontinued and the patient subjected to strict medical monitoring with the introduction of appropriate follow-up until these symptoms have completely regressed in the long term.
Patients with a history of angioedema not associated with racecadotril treatment may be at increased risk of developing angioedema.
Effects on ability to drive and use machines: Racecadotril has no or negligible influence on the ability to drive and use machines.