Europe — EMA
Hidrasec
Hidrasec contains racecadotril, an oral OTC antidiarrheal that reduces intestinal secretion in acute diarrhea. Learn uses, safety, and FAQs.
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What is Racecadotril?
Hidrasec is an oral over‑the‑counter medication whose active ingredient is racecadotril, an enkephalinase inhibitor marketed in the European Union. The product is supplied as a tablet (strength not specified) and is classified as an antidiarrheal agent. Racecadotril works by modulating intestinal secretions, providing symptomatic relief for acute diarrhea without affecting systemic absorption. Hidrasec is intended for short‑term use in adults, children, and adolescents under medical guidance.
What is Racecadotril used for?
Hidrasec is indicated for the symptomatic treatment of acute diarrhea in patients who require rapid reduction of stool frequency and volume, and who are able to maintain oral intake.
- Mild to moderate acute infectious diarrhea in adults, especially when caused by bacterial pathogens such as E. coli or Shigella. - Acute diarrheal episodes in children older than six months, used as part of a rehydration plan to limit fluid loss. - Traveler’s diarrhea of short duration when dehydration risk is low, providing a non‑antibiotic option for symptom control. - Diarrhea associated with viral gastroenteritis where antimicrobial therapy is not indicated, helping to reduce stool output while the infection resolves. - Adjunctive therapy alongside oral rehydration solutions to maintain hydration status during the acute phase.
What are the side effects of Racecadotril?
Adverse reactions to Hidrasec are generally mild and transient, but rare serious events have been reported in clinical use.
Common: - Mild abdominal discomfort or cramping, usually transient. - Nausea or brief episodes of vomiting. - Headache, often mild and short‑lasting. - Flatulence or bloating, generally mild. - Dizziness, typically resolving without intervention. - Mild fatigue, not interfering with daily activities.
Serious: - Allergic skin reactions such as rash, urticaria, or pruritus. - Severe hypersensitivity reactions, including angioedema or anaphylaxis. - Persistent diarrhea despite therapy, which may indicate a paradoxical response. - Severe abdominal pain that is sudden or worsening. - Signs of intestinal obstruction, such as persistent vomiting, inability to pass gas, and abdominal distension.
What precautions apply to Racecadotril?
When using Hidrasec, certain precautions should be observed to ensure safe and effective therapy.
- Assess hydration status before initiating treatment; severe dehydration requires medical supervision. - Do not use in patients with known hypersensitivity to racecadotril or any excipients. - Limit use to short‑term episodes; prolonged therapy has not been established. - Caution in children under six months of age, as safety data are limited. - Pregnancy and lactation: consult a healthcare professional because safety has not been fully determined. - Monitor for worsening diarrhea or signs of infection; seek medical advice if symptoms persist.
What does Racecadotril interact with?
Hidrasec may interact with other medicines; consider the following guidance when co‑administering.
Avoid: - Concurrent use with potent enkephalinase inhibitors, as additive effects on intestinal secretion are not established. - Combination with agents that significantly slow gastrointestinal motility, which could increase the risk of constipation.
Use with caution: - Anticholinergic drugs, because combined effects may alter gut motility. - Diuretic therapy, as excessive fluid loss from diarrhea could affect electrolyte balance. - Other over‑the‑counter antidiarrheal products, to avoid overlapping mechanisms. - Proton pump inhibitors, because altered gastric pH may affect drug absorption. - Antibiotics for gastrointestinal infections, to ensure that the underlying cause is treated.
Frequently asked questions
What is the active ingredient in Hidrasec?+
How does Hidrasec differ from loperamide?+
Can Hidrasec be used in children?+
Is a prescription required for Hidrasec in the EU?+
What should I do if diarrhea persists after taking Hidrasec?+
Are there any dietary restrictions while taking Hidrasec?+
Can Hidrasec be taken with oral rehydration solutions?+
Is Hidrasec safe during pregnancy?+
What are common side effects of Hidrasec?+
Should I avoid other antidiarrheal medications while using Hidrasec?+
How quickly does Hidrasec start to work?+
What is the mechanism by which racecadotril reduces diarrhea?+
Product details
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