Europe — EMA
Hidrasec
Learn about Hidrasec racecadotril, an OTC oral antidiarrheal in the EU, its uses, mechanism, safety profile, and precautions.
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What is Racecadotril?
Hidrasec is an oral antidiarrheal medication whose active ingredient is racecadotril. It is marketed in the European Union as an over‑the‑counter (OTC) product. Racecadotril belongs to the enkephalinase inhibitor class and is supplied in tablet form, providing a non‑opioid option for managing acute diarrhoea. The formulation is designed for convenient self‑administration and does not require a prescription, making it accessible for adults and children experiencing sudden gastrointestinal fluid loss.
What is Racecadotril used for?
Hidrasec is indicated for the symptomatic relief of acute diarrhoea in patients where rapid control of stool output is desired.
- Short‑term treatment of acute infectious or non‑infectious diarrhoea in adults. - Adjunct therapy for children with acute watery diarrhoea, when oral rehydration is possible. - Management of diarrhoea associated with travel or dietary changes. - Use in patients who require a non‑opioid antidiarrheal to avoid constipation. - Supportive care in outpatient settings to reduce fluid loss and electrolyte imbalance.
What are the side effects of Racecadotril?
Like all medicines, Hidrasec may cause adverse reactions, although most are mild and transient.
Common: - Nausea or mild stomach discomfort. - Headache. - Dizziness. - Transient abdominal cramps. - Dry mouth.
Serious: - Severe allergic reaction (rash, itching, swelling, difficulty breathing). - Persistent vomiting or diarrhoea despite treatment. - Marked hypotension or fainting. - Signs of hepatic dysfunction (jaundice, dark urine, elevated liver enzymes). - Unexplained rash or urticaria.
What precautions apply to Racecadotril?
Before using Hidrasec, certain health considerations should be reviewed to ensure safe use.
- Avoid use in patients with known hypersensitivity to racecadotril or any excipients. - Use caution in individuals with severe hepatic impairment, as metabolism may be affected. - Not recommended for infants younger than 6 months without medical supervision. - Consider renal function; dose adjustment may be needed in severe renal failure. - Pregnant or breastfeeding women should consult a healthcare professional before use. - Monitor for worsening diarrhoea or signs of dehydration; seek medical attention if symptoms persist.
What does Racecadotril interact with?
Hidrasec can interact with other medicines; awareness of potential interactions helps prevent reduced efficacy or increased risk.
Avoid: - Concomitant use with potent opioid analgesics, which may mask gastrointestinal symptoms. - Combination with other antidiarrheal agents (e.g., loperamide) that could cause excessive reduction of gut motility. - Combination with bismuth subsalicylate, which may reduce antidiarrheal effect.
Use with caution: - Anticholinergic drugs, as they may enhance constipation risk. - Diuretics, because altered fluid balance could affect diarrhoea management. - Medications metabolized by hepatic enzymes (e.g., CYP3A4 substrates), as racecadotril may influence their clearance. - Oral rehydration solutions, ensuring they are administered appropriately alongside the drug.
Frequently asked questions
What is the active ingredient in Hidrasec?+
Is Hidrasec available without a prescription in the EU?+
How does Hidrasec differ from opioid antidiarrheals like loperamide?+
Can children use Hidrasec for acute diarrhoea?+
What should I do if I experience a rash after taking Hidrasec?+
Is it safe to take Hidrasec while pregnant?+
How quickly does Hidrasec start to reduce stool frequency?+
Should I continue oral rehydration therapy while using Hidrasec?+
Can Hidrasec be taken with other medications for stomach upset?+
What are the storage conditions for Hidrasec?+
Does Hidrasec affect the absorption of other oral drugs?+
How long can I use Hidrasec for acute diarrhoea?+
Product details
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