Racetril 10

Rx

Indications

• Complementary symptomatic treatment of acute diarrhoea in infants (older than 3 months) and in children together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition, and when causal treatment is not possible.
• If causal treatment is possible, racecadotril can be administered as a complementary treatment.

Dosage

• Racetril 10 is intended for children < 13 kg.
• The recommended dose is determined according to body weight: 1.5 mg/kg per dose (corresponding to 1 to 2 sachets), three times daily at regular intervals.
  In infant less than 9 kg: One Racetril 10 sachet 3 times daily.
  In infant from 9 kg to 13 kg: Two Racetril 10 sachets 3 times daily.
• The duration of treatment in the clinical trials with children was 5 days. Treatment should be continued until two normal stools are recorded but should not exceed 7 days.
• There are no clinical trials in infants fewer than 3 months of age.
• Special populations
  There are no studies in infants or children with renal impairment or hepatic impairment.
  Caution is advised in patients with hepatic or renal impairment.

Usage

• Racetril is administered via the oral route, together with oral rehydration.
• The granules can be added to food, dispersed in a glass of water or in the feeding-bottle, mixing well and followed by immediate administration.

• Hypersensitivity to any of the ingredients.
• Racetril contains sucrose (saccharose). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
• Infants less than 3 months old.

Uncommon

• Tonsillitis.
• Rash, erythema.

• The administration of racecadotril does not modify the usual rehydration regimens. Rehydration is highly important in the management of acute diarrhoea in infants.
• The presence of bloody or purulent stools and fever may indicate the presence of invasive bacteria as a reason for diarrhoea, or the presence of other severe disease. Also, racecadotril has not been tested in antibiotic-associated diarrhoea. Therefore, racecadotril should not be administered under these conditions.
• Chronic diarrhoea has not been sufficiently studied with racecadotril.
• It should be taken into account that each Racetril 10 sachet contains 0.9635 g of sucrose. If the quantity of sucrose (source of glucose and fructose) present in the daily dose of racetril exceeds 5 g a day, the latter should be taken into account in the daily sugar ration.
• The product must not be administered to children with renal or liver impairment, whatever the degree of severity.
• The product must not be administered in cases of prolonged or uncontrolled vomiting.
• When experiencing severe skin reactions, the treatment has to be stopped immediately.
• Hypersensitivity/angioneurotic oedema may occur at any time during therapy. Angioedema of the face, extremities, lips, mucous membranes may occur. Where there is angioedema associated with upper airway obstruction, such as tongue, glottis and/or larynx, Racecadotril should be discontinued and the patient should be under emergency therapy should be administered promptly.
• Concomitant use of racecadotril and ACE inhibitors may increase the risk of angioedema.
• Pregnant and lactating women should not use racecadotril.
• Racecadotril has no or negligible influence on the ability to drive and use machines.