Racecadotril is indicated as an adjunct to rehydration therapy for the symptomatic treatment of acute secretory diarrhoea.

Racecadotril is a prodrug that is converted by hydrolysis into its active metabolite, thiorphan. Thiorphan acts as an inhibitor of enkephalinase.

Enkephalinase is a membrane-bound peptidase found in various tissues, especially in the small intestinal epithelium. It breaks down both exogenous peptides and endogenous peptides (enkephalins). By inhibiting enkephalinase, racecadotril prevents the degradation of enkephalins, thereby prolonging their action at enkephalinergic synapses in the small intestine. This leads to reduced hypersecretion of water and electrolytes. Racecadotril produces a rapid antidiarrhoeal effect without affecting intestinal transit time. It does not cause abdominal distension.

Adults: One capsule initially regardless of the time of the day; then one capsule 3 times daily (preferable before food) until diarrhea stops.

Children (3 months to 18 years): Racecadotril is suitable for children over 3 months of age.

• Recommended dose is 1.5 mg/kg body weight.
• If Body weight less than 9 kg: 10 mg 3 times daily.
• If Body weight 9-13 kg: 20 mg 3 times daily.
• If Body weight 13-27 kg: 30 mg 3 times daily.
• If Body weight over 30 kg: 60 mg 3 times daily.

Maximum duration of treatment is 7 days.

How to use sachet:

• Dissolve the powder in 20 ml pure water
• Stir well
• After dissolving the powder drink full suspension immediately

No clinically significant drug interactions have been reported in humans to date. Co-administration of racecadotril with loperamide or nifuroxazide does not alter the pharmacokinetics of racecadotril.

Racecadotril is contraindicated in patients with known hypersensitivity to any of its components.

Headache, skin rash, and erythema.

Due to insufficient clinical data, racecadotril is not recommended during pregnancy or breastfeeding.

Racecadotril does not replace standard rehydration therapy and should be used as an adjunct only. Limited data are available in patients with renal or hepatic impairment; therefore, it should be used with caution in such patients.

No cases of overdose have been reported. In adults, single doses above 2 g (approximately 20 times the therapeutic dose) have been administered without any reported harmful effects.

Anti-diarrhoeal

Store below 30°C, protect from light and moisture. Keep out of reach of children.