Radola Capsule

Radola is indicated for the symptomatic treatment of acute diarrhea.

Radola is a pure intestinal antisecretory active substance. It decreases the intestinal hypersecretion of water and electrolytes induced by cholera toxin or inflammation and does not have effects on basal secretory activity.

Following oral administration, Radola is rapidly absorbed and then hydrolysed to thiorphan, which is an inhibitor of enkephalinase, a cell membrane peptidase located in various tissues, notably the epithelium of the small intestine. This enzyme contributes both to the hydrolysis of exogenous peptides and to the breakdown of endogenous peptides such as enkephalins. Radola protects enkephalins from enzymatic degradation thereby prolonging their action at enkephalinergic synapses in the small intestine and reducing hypersecretion. Radola exerts rapid antidiarrhoeal action, without modifying the duration of intestinal transit.

Racecadotril increases the availability of endogenous opioids (enkephalins) by inhibiting the membrane-bound enkephalinase. The enkephalins in turn mediate their effect through δ receptor ( delta opioid receptor) activation that induces a selective increase in Cl absorption by inhibiting adenylate cyclase.

Onset: 30 min (plasma enkephalinase inhibition).

Adults: One capsule initially, regardless of the time of day. Then one capsule three times daily preferably before the main meals.

Children (from 3 months of age): Racecadotril granules should be administered together with oral rehydration. The recommended dose is determined according to body weight: 1.5 mg/kg per administration, three times daily.

• Infants less than 9 kg: one 10 mg sachet 3 times daily.
• Infants from 9 kg to 13 kg: two 10 mg sachets 3 times daily.
• Children from 13 kg to 27 kg: one 30mg sachet 3 times daily.
• Children of more than 27 kg: two 30mg sachets 3 times daily.

No drug interactions found. Joint treatment with Radola and Loperamide or Nifuroxazide does not modify the kinetics of Radola.

Hypersensitivity to Racecadotril, or to any of the excipients.

Headache, erythema multiforme, urticaria, angioedema may be seen.

Due to a lack of clinical data, Racecadotril should not be administered to pregnant or breastfeeding women.

The administration of Radola does not modify the usual rehydration regimens. The presence of bloody stools and fever may indicate the presence of invasive bacteria as a reason for diarrhea or the presence of other severe disease. Radola has not been tested in antibiotic-associated diarrhea and should therefore not be administered under these conditions. Caution should be taken in patients with renal or liver impairment.

No cases of overdose have been reported. In adults, single doses above 2 g which is equivalent to 20 times the therapeutic dose, have been administered, and no harmful effects have been described.

Anti-diarrhoeal