Hidrasec

Cap: Symptomatic treatment of acute diarrhoea in adults. Granules for oral susp: Complementary symptomatic treatment of acute diarrhoea in infants >3 mth & childn together w/ oral rehydration & usual support measures, when these measures alone are insufficient to control the clinical condition & when causal treatment is not possible. Can be administered as a complementary treatment if causal treatment is possible.

Max treatment duration: 7 days. Cap Adult Initially 1 cap regardless of time, then 1 cap at the beginning of the 3 main meals. Granules for oral susp 1.5 mg/kg/dose (corresponding to 1-2 sachets), tds at regular intervals. Childn weighing >27 kg Two 30-mg sachets tds, 13-27 kg One 30-mg sachet tds. Infant weighing 9-13 kg Two 10-mg sachets tds, <9 kg One 10-mg sachet tds.

Cap: May be taken with or without food. Granules for oral susp: May be taken with or without food: Can be added to food or dispersed in a glass of water or in the feeding bottle, then mix well & immediately consume.

Hypersensitivity. Granules for oral susp: Patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or saccharase-isomaltase deficiency.

Must not be used in antibiotic-related diarrhoea. Insufficient data regarding chronic diarrhoea & this medicinal product. Immediately discontinue treatment if severe skin reactions appear. Risk of hypersensitivity, Quincke's/angioneurotic oedema, & angioedema of the face, extremities, lips & mucosa. Patients w/ history of angioedema not associated w/ racecadotril treatment may be at increased risk of angioedema. Cap: Not a substitute for rehydration, if required. Must not be used if signs of acute dysenteric syndrome are present eg, bloody stools or fever. Bioavailability may be reduced in patients w/ prolonged vomiting. Not recommended in patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome. Caution in patients w/ renal or hepatic impairment. Preferable to avoid use during pregnancy. Should not be administered during breastfeeding. Must not be administered to infants & childn. Granules for oral susp: Does not modify usual rehydration regimens. Consider IV rehydration in case of serious or prolonged diarrhoea w/ significant vomiting or lack of appetite. Must not be administered in cases of prolonged or uncontrolled vomiting. Each 10-mg sachet contains 0.9665 g of sucrose & each 30-mg sachet contains 2.8995 g of sucrose; caution in patients w/ diabetes. Must not be administered to childn w/ renal or hepatic impairment. No clinical trials in infants <3 mth of age.

Rash, erythema (uncommon). Cap: Headache (common). Granules for oral susp: Tonsillitis (uncommon).

Concomitant use w/ ACE inhibitors (eg, captopril, enalapril, lisinopril, perindopril, ramipril) may increase risk of angioedema.

Antidiarrheals

A07XA04 - racecadotril ; Belongs to the class of other antidiarrheals.

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