Hidrasec Special Precautions

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.
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.
Effects on ability to drive and use machines: Racecadotril has no or negligible influence on the ability to drive and use machines.
Granules for oral suspension: The administration of Hidrasec Infants or Hidrasec Children does not modify the usual rehydration regimens. 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.
In the event of serious or prolonged diarrhoea with important vomiting or a lack of appetite, intravenous rehydration should be considered.
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 tested in antibiotic-associated diarrhoea. Therefore, racecadotril should not be administered under these conditions.
Chronic diarrhoea has not been sufficiently studied with Hidrasec Children.
Effects on ability to drive and use machines: Not relevant.
Racecadotril has no or negligible influence on the ability to drive and use machines.