Europe — EMA
Hidrasec Children (Racecadotril)
Hidrasec Children is an OTC oral antidiarrheal containing racecadotril, used for acute diarrhea in children in the EU.
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What is Racecadotril?
Hidrasec Children is an oral antidiarrheal medication that contains the active ingredient racecadotril. It is marketed in the European Union as an over‑the‑counter (OTC) product for pediatric use. The specific strength and dosage form are not disclosed, but the preparation is intended to manage acute diarrhea in children by targeting intestinal secretions without systemic opioid effects.
What is Racecadotril used for?
Hidrasec Children is indicated for the symptomatic relief of acute diarrhea in pediatric patients. It is used to reduce stool frequency and fluid loss, helping to maintain hydration and comfort during short‑term gastrointestinal upset.
- Treatment of acute, non‑bloody diarrhea in children - Adjunct to oral rehydration therapy to limit fluid loss - Management of watery stools caused by viral gastroenteritis - Supportive care for mild to moderate diarrheal episodes in infants and toddlers - Use in conjunction with dietary measures to restore normal bowel function
What are the side effects of Racecadotril?
Adverse reactions to Hidrasec Children are generally uncommon, but they can occur. Patients and caregivers should be aware of both frequent and rare events.
Common: - Mild abdominal discomfort or cramps - Nausea or transient vomiting - Headache - Dizziness - Mild rash or skin irritation
Serious: - Allergic reactions such as urticaria, angioedema, or anaphylaxis - Severe skin reactions (e.g., Stevens‑Johnson syndrome) - Persistent vomiting leading to dehydration - Signs of hypersensitivity (e.g., swelling of face, lips, tongue)
What precautions apply to Racecadotril?
Before using Hidrasec Children, consider the following safety points. The product is intended for short‑term use and should not replace medical evaluation for severe or persistent diarrhea.
- Verify the child’s age and weight to ensure appropriate use - Avoid use in children with known hypersensitivity to racecadotril or any excipients - Do not use if diarrhea is accompanied by high fever, blood in stool, or signs of dehydration - Consult a healthcare professional if diarrhea persists longer than 48‑72 hours - Use alongside oral rehydration solutions to maintain fluid balance - Keep out of reach of children to prevent accidental ingestion of excessive amounts
What does Racecadotril interact with?
While Hidrasec Children has a limited interaction profile, certain substances may affect its safety or efficacy.
Avoid: - Concurrent use of other antidiarrheal agents (e.g., loperamide) without medical advice - Administration with opioid analgesics that could potentiate central opioid effects
Use with caution: - Antacids that may alter gastrointestinal pH and affect drug absorption - Medications that prolong QT interval, though evidence is limited - Herbal supplements affecting gut motility (e.g., senna, cascara) - Broad‑spectrum antibiotics that may change gut flora and diarrhea etiology



