Europe — EMA
Hidrasec
Learn about Hidrasec racecadotril – an OTC oral antidiarrheal from the EU, its uses, mechanism, side effects, precautions, and drug interactions.
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What is Racecadotril?
Hidrasec is an over‑the‑counter oral medication that contains the active ingredient racecadotril; the specific strength and dosage form are not disclosed in the product listing. It belongs to the enkephalinase inhibitor class and is marketed in the European Union for the symptomatic relief of acute diarrhea. As a non‑prescription drug, Hidrasec is intended for short‑term use in adults and children when appropriate under medical guidance.
What is Racecadotril used for?
Hidrasec is indicated for the short‑term management of acute diarrhea in patients who need rapid symptom control, and it can be used alongside oral rehydration solutions to support fluid balance.
- Adults experiencing acute watery or loose stools. - Children (including infants) with sudden onset diarrhea. - Travelers who develop diarrhea during short trips. - Diarrhea secondary to viral or bacterial gastroenteritis. - Use as an adjunct to oral rehydration therapy for fluid replacement. - Patients with diarrhea due to food intolerance. - Individuals needing temporary reduction of intestinal secretions.
What are the side effects of Racecadotril?
Adverse reactions are generally mild and self‑limiting, but patients should be aware of both common and rare serious events that may require medical attention, especially if symptoms persist or worsen.
Common: - Nausea or mild stomach discomfort. - Headache. - Dizziness. - Transient abdominal cramps. - Dry mouth. - Mild fatigue. - Transient taste alteration. - Mild constipation.
Serious: - Allergic skin rash or urticaria. - Severe abdominal pain. - Signs of anaphylaxis (rare). - Marked liver enzyme elevation. - Severe electrolyte imbalance. - Renal function impairment.
What precautions apply to Racecadotril?
When using Hidrasec, certain precautions should be considered to ensure safe and effective use, particularly in specific populations or clinical situations.
- Do not use if you have a known hypersensitivity to racecadotril or any excipients. - Assess hydration status and replace fluids appropriately before starting treatment. - Use with caution in patients with severe renal or hepatic impairment. - Consult a healthcare professional before use in infants younger than 3 months. - Avoid prolonged use beyond the recommended duration for acute diarrhea. - Monitor for worsening diarrhea or signs of infection. - Pregnant or breastfeeding women should seek medical advice prior to use.
What does Racecadotril interact with?
Racecadotril may interact with other medicines, affecting its efficacy or safety profile; reviewing concomitant drugs is advisable.
Avoid: - Concurrent use of potent enkephalinase inhibitors that could amplify opioid‑like effects. - Co‑administration with drugs that significantly alter intestinal motility, such as strong anticholinergics. - Combination with other opioid‑like agents may increase risk of central side effects.
Use with caution: - Diuretics, because changes in fluid balance may affect hydration status. - Antihypertensive agents, as dehydration from diarrhea could potentiate blood pressure lowering. - Other antidiarrheal agents, to avoid excessive reduction of gut motility. - Medications that affect liver enzymes (e.g., CYP inhibitors) may modify racecadotril metabolism. - Antacids or agents that alter gastric pH could affect absorption. - Herbal supplements with laxative properties should be used cautiously.
Frequently asked questions
What is Hidrasec and what does it contain?+
How does racecadotril work to treat diarrhea?+
Is Hidrasec available without a prescription in the EU?+
For which types of diarrhea is Hidrasec recommended?+
Can children use Hidrasec, and what age groups are appropriate?+
What are the most common side effects of Hidrasec?+
Are there any serious adverse reactions associated with racecadotril?+
What precautions should be taken before starting Hidrasec?+
How should Hidrasec be stored?+
Can Hidrasec be taken with other antidiarrheal medications?+
Does racecadotril interact with common medications like diuretics or antihypertensives?+
What should I do if I miss a dose of Hidrasec?+
Product details
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