Hidrasec

Cap: Symptomatic treatment of acute diarrhoea in adults. Granules for oral susp: Supplement to oral rehydration for the symptomatic treatment of acute diarrhoea in childn (30 mth to 14 yr) & infants (1-30 mth).

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 Determine daily dose according to body wt on the basis of 1.5 mg/kg/dose. 1st day: 1 initial dose & then 3 doses spread throughout the day. Subsequent days: 3 doses spread throughout the day. Recommended daily dose: 6 mg/kg. Childn >9 yr weighing >27 kg Two 30-mg sachets/dose, 30 mth to 9 yr weighing 13-27 kg One 30-mg sachet/dose. Infant 9-30 mth weighing 9-13 kg Two 10-mg sachets/dose, 1-9 mth weighing <9 kg One 10-mg sachet/dose.

Cap: May be taken with or without food. Granules for oral susp: May be taken with or without food: Swallow as is. Alternatively, add to food or mix w/ water, then stir well & swallow whole mixt immediately.

Hypersensitivity.

Not a substitute for rehydration, if required. Immediately discontinue treatment if severe skin reactions appear. Risk of hypersensitivity, Quincke's oedema, & angioedema of the face, extremities, lips & mucosa. Patients w/ history of angioedema not associated w/ racecadotril treatment may be at increased risk of developing angioedema. Must not be used in antibiotic-related diarrhoea. Potentially reduced bioavailability in cases of prolonged or uncontrollable vomiting. Avoid use during pregnancy. Do not administer during breast-feeding. Cap: Must not be used if signs of acute dysenteric syndrome are present eg, bloody stools or fever. Insufficient data regarding chronic diarrhoea. Not recommended in patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome. Caution in patients w/ hepatic or renal impairment. Must not be administered to infants & childn. Granules for oral susp: Not recommended in patients w/ fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency. Consider daily allowance of patients on slow-sugar diet or w/ diabetes if >5 g/day sucrose in the daily dose. No studies in childn <3 mth & childn w/ hepatic or renal impairment.

Rash & erythema (uncommon). Cap: Headache (common).

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.

P₁S₁S₃