Europe — EMA
Hidrasec Pro Děti (Racecadotril)
Learn about Hidrasec Pro Děti, a racecadotril oral antidiarrheal for children, its uses, mechanism, side effects, precautions, and interactions.
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What is Racecadotril?
Hidrasec Pro Děti is an oral pediatric formulation containing the active ingredient racecadotril. It is marketed in the European Union as an enkephalinase inhibitor used for the symptomatic treatment of acute diarrhea in children. The product is supplied without a specified strength in the available information, and it is intended for oral administration. It is classified under ATC code A07DA03 and belongs to the therapeutic class of antidiarrheal agents.
What is Racecadotril used for?
Hidrasec Pro Děti is indicated for the management of acute, non‑bloody diarrhea in children, helping to reduce stool frequency and volume while maintaining hydration.
- Symptomatic relief of watery stools in infants and toddlers. - Support of oral rehydration therapy by decreasing intestinal fluid loss. - Use in cases of viral gastroenteritis where bacterial infection is not confirmed. - Adjunct treatment for travel‑related diarrhea in pediatric travelers. - Suitable for short‑term use during the acute phase of diarrheal illness.
What are the side effects of Racecadotril?
Like many antidiarrheal agents, racecadotril may be associated with adverse reactions, most of which are mild and transient.
Common: - Mild abdominal discomfort or cramping. - Nausea or occasional vomiting. - Transient headache. - Slight increase in serum creatinine in rare cases. - Skin rash or mild pruritus.
Serious: - Allergic reactions such as urticaria, angioedema, or anaphylaxis. - Severe abdominal pain indicative of intestinal obstruction. - Persistent vomiting leading to dehydration. - Hepatic dysfunction manifested by elevated transaminases. - Nephrotoxicity in patients with pre‑existing kidney disease.
What precautions apply to Racecadotril?
When prescribing Hidrasec Pro Děti, clinicians should consider several precautionary measures to ensure safe use in pediatric patients.
- Verify that diarrhea is not caused by invasive bacterial infection before initiating therapy. - Assess hydration status and continue oral rehydration solutions alongside the medication. - Use with caution in children with known hypersensitivity to racecadotril or its excipients. - Monitor renal and hepatic function in patients with pre‑existing organ impairment. - Avoid prolonged use beyond the acute episode of diarrhea. - Do not substitute the drug for necessary antibiotic therapy when bacterial infection is confirmed. - Keep the product out of reach of children to prevent accidental ingestion.
What does Racecadotril interact with?
Racecadotril may interact with other medicines, affecting its efficacy or safety profile.
Avoid: - Concomitant use with potent opioid agonists that act centrally, as they may mask symptoms and increase risk of respiratory depression. - Co‑administration with drugs that strongly inhibit renal excretion, potentially raising thiorphan levels.
Use with caution: - Anticholinergic agents that can exacerbate constipation when combined. - Non‑steroidal anti‑inflammatory drugs (NSAIDs) in children with compromised renal function. - Other antidiarrheal agents such as loperamide, due to additive effects on intestinal motility. - Vaccines containing live attenuated viruses, although no direct interaction is documented, monitor clinical response.



