GNH USA

Europe — EMA

Hidrasec Infants And Children

Information on Hidrasec Infants and Children, an OTC oral racecadotril antidiarrheal for infants and children, including uses, safety and FAQs.

Racecadotril

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What is Racecadotril?

Hidrasec Infants and Children is an over‑the‑counter oral formulation that contains the active ingredient racecadotril. It is marketed in the European Union for use in pediatric patients with acute diarrhea. The product is supplied as a liquid preparation suitable for infants and young children, allowing dose adjustment by weight. Racecadotril belongs to the enkephalinase‑inhibitor class and works locally in the gut to reduce fluid loss.

What is Racecadotril used for?

Hidrasec Infants and Children is indicated for the symptomatic management of acute, non‑bloody diarrhea in pediatric patients, helping to limit excessive stool output and dehydration risk.

- Provides antidiarrheal effect by reducing intestinal secretions. - Can be used in infants from a few months of age up to school‑age children. - Intended for short‑term treatment of acute diarrheal episodes. - May be combined with oral rehydration solutions as part of standard care. - Suitable for use when a non‑opioid antidiarrheal is preferred.

What are the side effects of Racecadotril?

Like most medications, racecadotril may cause adverse reactions, most of which are mild and transient.

Common: - Mild abdominal discomfort or cramping. - Nausea, occasional vomiting, or loss of appetite. - Transient headache or dizziness. - Slight increase in flatulence or gas. - Temporary worsening of diarrhea in the first 24 hours.

Serious: - Allergic skin reactions such as rash, itching or urticaria. - Severe hypersensitivity with swelling of the face, lips, tongue or throat. - Persistent vomiting leading to dehydration or electrolyte imbalance. - Unexplained fever, severe abdominal pain, or bloody stools.

What precautions apply to Racecadotril?

When using Hidrasec Infants and Children, certain precautions should be considered to ensure safe and effective therapy.

- Verify that the diarrhea is acute, non‑bloody and not caused by a known infection requiring antibiotics. - Use only in children for whom the product is intended; do not give to infants younger than the label age. - Do not exceed the recommended short‑term course without medical advice. - Monitor hydration status and continue oral rehydration therapy alongside the medication. - Stop the product if an allergic reaction or severe side effect occurs and seek care. - Ask a clinician before use in children with chronic GI disorders or severe malnutrition.

What does Racecadotril interact with?

Racecadotril may interact with other medicines; awareness of potential interactions helps maintain safety.

Avoid: - Concomitant use with other opioid‑type antidiarrheal agents such as loperamide, which may increase the risk of constipation. - Co‑administration with drugs that significantly alter gastrointestinal motility, as the combined effect on fluid balance is unpredictable.

Use with caution: - Antacids or medications that affect gastric pH, which could modify the absorption of oral racecadotril. - Broad‑spectrum antibiotics, because underlying infection may be masked while diarrhea is suppressed. - Any drug that may cause hypersensitivity reactions, to monitor for additive allergic risk.

Frequently asked questions

What is the active ingredient in Hidrasec Infants and Children?+
The active ingredient is racecadotril, an enkephalinase inhibitor used as an antidiarrheal.
For which age group is Hidrasec Infants and Children intended?+
It is formulated for infants and children, typically from a few months up to around 12 years, as indicated on the product label.
How does racecadotril differ from opioid antidiarrheals like loperamide?+
Racecadotril works peripherally by inhibiting enkephalinase, increasing endogenous enkephalins without affecting intestinal motility, whereas loperamide reduces gut movement by acting on opioid receptors.
Can Hidrasec Infants and Children be used together with oral rehydration solutions?+
Yes, it is generally recommended to continue oral rehydration therapy alongside the medication to maintain hydration.
What should I do if my child experiences a rash while taking Hidrasec Infants and Children?+
Discontinue the product immediately and seek medical advice, as a rash may indicate an allergic reaction.
Is a prescription required to purchase Hidrasec Infants and Children in the EU?+
No, the product is available over the counter in most EU countries.
How long should a typical course of Hidrasec Infants and Children last?+
Treatment is usually limited to a short course of a few days; prolonged use should be discussed with a healthcare professional.
Are there any known drug interactions with racecadotril?+
Racecadotril may interact with other antidiarrheals, drugs affecting gut motility, antacids, and certain antibiotics; consult a pharmacist for guidance.
What are the most common side effects reported with racecadotril in children?+
Common adverse effects include mild abdominal discomfort, nausea, headache, increased gas, and temporary worsening of diarrhea.
Should Hidrasec Infants and Children be given to a child with chronic gastrointestinal disease?+
Use only under medical supervision, as chronic conditions may require specific management.
Is racecadotril safe during pregnancy or breastfeeding?+
Safety data are limited; consult a healthcare provider before use in pregnant or nursing mothers.
How should the medication be stored?+
Keep the product in its original container, protect from light, and store at room temperature away from moisture.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Racecadotril
Route
Oral Use
Manufacturer
Bioprojet Pharma
Origin
EU

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