Product image of Hidrasec Για Βρεφη (Racecadotril) supplied by GNH India

Hidrasec Για Βρεφη

Active Ingredient:
Racecadotril
Origin:
EU

Hidrasec Για Βρεφη (Racecadotril)

Hidrasec Για Βρεφη is a pediatric oral 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 infants and young children. The product does not contain a defined strength in the public data, and it is supplied as a liquid or suspension intended for oral administration and caregivers as needed.

Manufacturer / TM Owner

Ferrer Internacional, S.A.

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Indications & Clinical Uses

Hidrasec Για Βρεφη is indicated for the management of acute, non‑bloody diarrhea in infants and children when rehydration therapy is required.

  • Provides symptomatic relief of watery stools in infants.
  • Reduces stool frequency and volume.
  • Used as an adjunct to oral rehydration solution (ORS) therapy.
  • Appropriate when bacterial infection has been excluded.
  • May be considered in community‑acquired diarrheal episodes.

How It Works

  • Racecadotril acts as an enkephalinase inhibitor in the intestinal mucosa, preventing the breakdown of endogenous enkephalins. The increased enkephalin levels activate opioid receptors on enteric neurons, which leads to reduced secretion of water and electrolytes into the intestinal lumen, thereby decreasing stool output without affecting intestinal motility.

Side Effects

Side effects of Hidrasec Για Βρεφη are generally mild, but serious reactions can occur in rare cases.

Common

  • Mild abdominal pain or discomfort.
  • Nausea or transient vomiting.
  • Flatulence or bloating.
  • Headache.
  • Constipation.
  • Transient skin rash.

Serious

  • Allergic reactions such as urticaria or anaphylaxis.
  • Severe skin reactions (e.g., Stevens‑Johnson syndrome).
  • Significant hepatic enzyme elevation.
  • Persistent severe dehydration despite treatment.

Precautions & Warnings

When using Hidrasec Για Βρεφη, caregivers should be aware of several safety considerations.

  • Ensure adequate oral rehydration is maintained alongside the medication.
  • Do not use for chronic or persistent diarrhea without medical evaluation.
  • Avoid use in infants with bloody stools or suspected dysentery.
  • Discontinue if signs of allergic reaction appear.
  • Use under medical supervision in patients with known hepatic or renal impairment.
  • Verify that the child has no known hypersensitivity to racecadotril or formulation excipients.

Avoid Interactions

Potential drug interactions with racecadotril should be considered.

Avoid

  • Concomitant use of other antidiarrheal agents such as loperamide.
  • Co‑administration with opioid analgesics that may alter gut motility.
  • Use with medications that strongly inhibit enkephalinase activity.

Use with caution

  • Oral rehydration solutions containing high electrolyte concentrations.
  • Antibiotics prescribed for bacterial gastroenteritis.
  • Anticholinergic drugs that may increase the risk of constipation.
  • Any medication that may affect hepatic metabolism.

Frequently Asked Questions

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

Racecadotril inhibits intestinal enkephalinase, increasing endogenous enkephalins which reduce secretion of water and electrolytes into the gut, thereby decreasing stool output.

Yes, it is commonly used as an adjunct to oral rehydration solutions to maintain hydration while reducing diarrhea symptoms.

Availability varies by country; in some EU markets it may be prescription‑only, while in others it could be sold over the counter. Local regulations should be consulted.

The product is formulated for infants and young children, typically from a few months up to 12 years, depending on local labeling.

Common side effects include mild abdominal pain, nausea, flatulence, headache, constipation, and transient skin rash.

If diarrhea persists for more than 48 hours, blood appears in the stool, signs of severe dehydration develop, or an allergic reaction occurs, medical attention should be sought.

Racecadotril should not be combined with other antidiarrheal agents like loperamide, and caution is advised when used with opioid analgesics or certain antibiotics.

No, it is intended for acute episodes of diarrhea; chronic diarrhea requires evaluation and a different therapeutic approach.

Store the product at room temperature, protected from light and moisture, and keep it out of reach of children.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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