Product image of Hidrasec Za Otroke (Racecadotril) supplied by GNH India

Hidrasec Za Otroke

Active Ingredient:
Racecadotril
Origin:
EU

Hidrasec Za Otroke (Racecadotril)

Hidrasec Za Otroke is an oral, over‑the‑counter medication that contains the active ingredient racecadotril. It is marketed in the European Union for pediatric use, with the specific strength and dosage form not publicly disclosed. As an enkephalinase inhibitor, the product is intended to manage acute diarrhea in children by targeting intestinal secretions. It is supplied without a prescription and follows standard OTC labeling according to regulatory guidance.

Manufacturer / TM Owner

Bioprojet Europe Ltd

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Indications & Clinical Uses

Hidrasec Za Otroke is used to provide symptomatic relief of acute, non‑bloody diarrhea in children, helping to reduce stool frequency and volume.

  • Management of watery stools associated with viral gastroenteritis in infants and young children.
  • Adjunct therapy for bacterial gastroenteritis‑related diarrhea when rehydration is the primary treatment.
  • Short‑term control of diarrhea caused by dietary indiscretion or mild infections.
  • Supportive care during travel‑related diarrheal episodes in pediatric travelers.
  • Use in conjunction with oral rehydration solutions to maintain fluid balance.
  • Temporary relief for diarrhea episodes lasting less than 48 hours in children under twelve years.

How It Works

  • Racecadotril acts peripherally by inhibiting the enzyme enkephalinase, which normally degrades endogenous enkephalins in the intestinal mucosa. By preventing this breakdown, higher concentrations of enkephalins remain active at opioid receptors on enteric neurons, leading to reduced secretion of electrolytes and water into the lumen and a modest decrease in intestinal motility. This antiperistaltic effect helps to normalize stool consistency without affecting systemic opioid pathways.

Side Effects

Like many antidiarrheal agents, racecadotril may cause adverse reactions, most of which are mild and transient.

Common

  • Mild abdominal discomfort or cramping.
  • Nausea or occasional vomiting.
  • Transient headache.
  • Flatulence or increased gas.
  • Loose stools may persist for a short period after treatment.
  • Mild dizziness or light‑headedness, especially in dehydrated children.
  • Temporary increase in thirst or dry mouth.

Serious

  • Allergic skin reactions such as rash, itching, or urticaria.
  • Severe abdominal pain with signs of intestinal obstruction.
  • Hypersensitivity reactions including swelling of the face, lips, or tongue.
  • Rare cases of pancreatitis reported in pediatric patients.
  • Signs of severe dehydration despite therapy, requiring medical attention.

Precautions & Warnings

When using Hidrasec Za Otroke, caregivers should observe several precautions to ensure safe and effective treatment in children.

  • Confirm that diarrhea is acute, non‑bloody, and not associated with high fever or severe abdominal pain before use.
  • Do not exceed the recommended duration of therapy, typically not longer than 48–72 hours without medical advice.
  • Ensure adequate fluid replacement with oral rehydration solutions alongside the medication.
  • Avoid use in children with known hypersensitivity to racecadotril or any excipients in the formulation.
  • Consult a healthcare professional if diarrhea persists, worsens, or is accompanied by blood or mucus.
  • Use cautiously in children with underlying renal or hepatic impairment, as dose adjustment may be required.

Avoid Interactions

Racecadotril may interact with certain medicines, affecting its efficacy or safety profile.

Avoid

  • Concurrent use with potent opioid agonists, as they may diminish the peripheral anti‑secretory effect of racecadotril.
  • Co‑administration with drugs that significantly alter intestinal motility, such as high‑dose loperamide, which could increase the risk of constipation.

Use with caution

  • Antibiotics that cause diarrhea as a side effect (e.g., clindamycin) – monitor clinical response.
  • Medications metabolized by hepatic enzymes that could be inhibited or induced, potentially affecting racecadotril clearance.
  • Electrolyte‑altering agents (e.g., oral rehydration solutions with high sodium) – adjust fluid therapy as needed.

Frequently Asked Questions

The active ingredient is racecadotril, an enkephalinase inhibitor used to treat acute diarrhea in children.

Yes, it is classified as an over‑the‑counter (OTC) medication in the European Union.

No, it is intended for non‑bloody, acute diarrhea. Bloody stools should be evaluated by a healthcare professional.

Racecadotril works peripherally by inhibiting enkephalinase, reducing intestinal secretion without affecting central opioid receptors, whereas loperamide primarily slows gut motility through opioid receptors.

It is formulated for pediatric patients, typically children under 12 years of age, but exact age limits are provided on the product label.

Yes, maintaining hydration with oral rehydration solutions is recommended alongside the medication to prevent dehydration.

Treatment is usually limited to a short course, often not exceeding 48–72 hours, unless directed otherwise by a healthcare professional.

Racecadotril may interact with potent opioid agonists and medications that significantly alter intestinal motility; other drugs should be used with caution.

Common side effects include mild abdominal discomfort, nausea, transient headache, flatulence, mild dizziness, and temporary increase in thirst.

Stop use if diarrhea persists beyond the recommended duration, worsens, or is accompanied by blood, mucus, severe pain, or signs of dehydration.

Caution is advised; dosage adjustments may be necessary, and a healthcare professional should be consulted before use.

It can be used with antibiotics, but monitoring is recommended because some antibiotics can cause diarrhea as a side effect.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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