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.
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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?+
For which age group is Hidrasec Infants and Children intended?+
How does racecadotril differ from opioid antidiarrheals like loperamide?+
Can Hidrasec Infants and Children be used together with oral rehydration solutions?+
What should I do if my child experiences a rash while taking Hidrasec Infants and Children?+
Is a prescription required to purchase Hidrasec Infants and Children in the EU?+
How long should a typical course of Hidrasec Infants and Children last?+
Are there any known drug interactions with racecadotril?+
What are the most common side effects reported with racecadotril in children?+
Should Hidrasec Infants and Children be given to a child with chronic gastrointestinal disease?+
Is racecadotril safe during pregnancy or breastfeeding?+
How should the medication be stored?+
Product details
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