Europe — EMA
Hidrasec Infants
Learn about Hidrasec Infants racecadotril – an OTC oral antidiarrheal for infants, its uses, mechanism, safety, and FAQs.
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What is Racecadotril?
Hidrasec Infants is an oral, over‑the‑counter preparation containing the enkephalinase inhibitor racecadotril. It is marketed in the European Union for the symptomatic relief of acute watery diarrhea in infants and young children. The product is supplied as a liquid formulation (strength not specified) and is intended for short‑term use under parental supervision. It does not require a prescription and is classified as an over‑the‑counter antidiarrheal agent.
What is Racecadotril used for?
Hidrasec Infants is indicated for the temporary relief of acute watery diarrhea in infants and young children.
- Management of dehydration risk associated with diarrheal episodes. - Adjunct to oral rehydration therapy (ORT) to reduce stool output. - Symptomatic control of loose stools caused by viral gastroenteritis. - Short‑term use in children up to a specified age as directed by healthcare professionals.
What are the side effects of Racecadotril?
Like all medicines, Hidrasec Infants may cause unwanted effects, although many users experience none.
Common: - Mild abdominal discomfort or cramping. - Nausea or transient vomiting. - Flatulence or mild bloating. - Constipation or reduced stool frequency. - Headache. - Skin rash or mild itching.
Serious: - Allergic reactions such as urticaria, angioedema, or anaphylaxis. - Severe skin reactions, including Stevens‑Johnson syndrome. - Persistent vomiting or severe abdominal pain. - Signs of hypersensitivity such as swelling of the face or throat.
What precautions apply to Racecadotril?
Before giving Hidrasec Infants, consider the following precautions to ensure safe use in children.
- Verify the child’s age and weight against product labeling. - Do not use in cases of bacterial dysentery or inflammatory bowel disease without medical advice. - Ensure adequate oral rehydration; the product is not a substitute for fluid replacement. - Keep out of reach of children; accidental ingestion of large amounts may cause toxicity. - Consult a pediatrician if diarrhea persists longer than 48‑72 hours or is accompanied by fever, blood, or mucus. - Avoid use in children with known hypersensitivity to racecadotril or its excipients.
What does Racecadotril interact with?
Hidrasec Infants can interact with other medicines; consider the following guidance.
Avoid: - Concomitant use with potent opioid agonists that may enhance central opioid effects. - Co‑administration with drugs that strongly inhibit neutral endopeptidase (NEP), as additive effects are not established.
Use with caution: - Anticholinergic agents that may affect gastrointestinal motility. - Other antidiarrheal agents (e.g., loperamide) due to overlapping mechanisms. - Medications that may cause electrolyte imbalance, such as diuretics, when combined with fluid loss from diarrhea.
Frequently asked questions
What is the active ingredient in Hidrasec Infants?+
Can Hidrasec Infants be used without a prescription?+
How does racecadotril differ from loperamide?+
Is Hidrasec Infants safe for newborns?+
Should Hidrasec Infants be given together with oral rehydration solution?+
What should I do if my child experiences a rash after taking Hidrasec Infants?+
Can racecadotril cause constipation?+
Are there any foods or drinks that should be avoided while using Hidrasec Infants?+
How long can Hidrasec Infants be used safely?+
What signs indicate that I should stop giving Hidrasec Infants and see a doctor?+
Is Hidrasec Infants suitable for children with chronic kidney disease?+
Can I store Hidrasec Infants at room temperature?+
Product details
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