Europe — EMA
Hidrasec Για Βρεφη
Learn about Hidrasec Για Βρεφη, a racecadotril oral antidiarrheal for infants, its uses, mechanism, side effects, precautions and FAQs.
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What is 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.
What is Racecadotril used for?
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.
What are the side effects of Racecadotril?
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.
What precautions apply to Racecadotril?
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.
What does Racecadotril interact with?
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
What is the active ingredient in Hidrasec Για Βρεφη?+
How does racecadotril reduce diarrhea in infants?+
Can Hidrasec Για Βρεφη be used together with oral rehydration solutions?+
Is Hidrasec Για Βρεφη available over the counter in the EU?+
What age group is Hidrasec Για Βρεφη intended for?+
What are the most common side effects of racecadotril in children?+
When should a caregiver stop using Hidrasec Για Βρεφη and seek medical help?+
Are there any known drug interactions with racecadotril?+
Can Hidrasec Για Βρεφη be used for chronic diarrhea?+
How should Hidrasec Για Βρεφη be stored?+
Product details
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