Europe — EMA
Hidrasec Pre Deti
Hidrasec Pre Deti contains racecadotril, an OTC enkephalinase inhibitor for pediatric acute diarrhea and gastroenteritis. Learn uses, safety and FAQs.
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What is Racecadotril?
Hidrasec Pre Deti is an over‑the‑counter oral product that contains the active ingredient racecadotril, an enkephalinase inhibitor used as an antidiarrheal. Marketed in the European Union, the preparation is intended for pediatric use and is supplied without a specified strength, reflecting its formulation as an oral suspension or tablet. It belongs to the therapeutic class of antidiarrheal agents and is available without a prescription in many EU pharmacies.
What is Racecadotril used for?
Hidrasec Pre Deti is used to manage sudden onset watery stools in pediatric patients, helping to control fluid loss and improve comfort.
- Acute infectious diarrhea caused by viruses or bacteria in children. - Acute gastroenteritis with accompanying loose stools and mild abdominal cramping. - Situations where oral rehydration therapy is being administered alongside antidiarrheal support. - Cases where reduction of stool frequency is desired to prevent dehydration. - Short‑term symptomatic relief during travel‑related diarrhoea in children. - Use as part of a comprehensive management plan for mild to moderate diarrhoeal episodes.
What are the side effects of Racecadotril?
Like most antidiarrheal agents, racecadotril may cause adverse reactions, most of which are mild and transient.
Common: - Nausea or mild stomach discomfort that usually resolves without treatment. - Transient abdominal cramps or mild pain occurring shortly after the first dose. - Headache or dizziness, often mild and self‑limiting. - Increased flatulence or mild constipation, especially when fluid intake is low. - Dry mouth or mild taste alteration, generally temporary.
Serious: - Allergic reactions such as rash, itching, urticaria, or facial swelling that require medical attention. - Severe skin reactions including Stevens‑Johnson syndrome or toxic epidermal necrolysis, though extremely rare. - Marked hepatic enzyme elevation or jaundice indicating possible liver involvement. - Severe constipation leading to intestinal obstruction, requiring prompt medical evaluation.
What precautions apply to Racecadotril?
When using Hidrasec Pre Deti, certain precautions should be observed to ensure safe and effective use in children.
- Ensure proper diagnosis, not used for chronic diarrhea. - Use only under guidance if dehydration present. - Not recommended for children with known hypersensitivity to racecadotril. - Caution in patients with severe hepatic or renal impairment. - Keep out of reach of children; accidental ingestion may cause adverse effects. - Monitor for signs of worsening condition; seek medical care if symptoms persist >48h. - Avoid use in infants under 3 months unless advised.
What does Racecadotril interact with?
Racecadotril may interact with other medicines, affecting its efficacy or safety profile.
Avoid: - Combination with other opioid‑type antidiarrheal agents (e.g., loperamide) that may increase risk of reduced gut motility. - Co‑administration with drugs that markedly inhibit neutral endopeptidase, which could theoretically raise enkephalin levels excessively.
Use with caution: - Concomitant use of medications that cause constipation (e.g., anticholinergics) as additive effects may lead to severe constipation. - Patients receiving nephrotoxic drugs (e.g., high‑dose NSAIDs) should be monitored because fluid balance changes could affect renal function. - Use together with hepatically metabolized drugs should be supervised, especially in children with liver impairment.
Frequently asked questions
What is the active ingredient in Hidrasec Pre Deti?+
How does racecadotril differ from loperamide?+
Is Hidrasec Pre Deti available without a prescription in the EU?+
For which age groups is Hidrasec Pre Deti intended?+
Can Hidrasec Pre Deti be used together with oral rehydration solutions?+
What are common side effects of racecadotril?+
What serious reactions should prompt medical attention?+
Should Hidrasec Pre Deti be used in children with chronic diarrhea?+
Are there any known drug interactions with racecadotril?+
What should be done if a dose of Hidrasec Pre Deti is missed?+
Product details
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