Prior and Concomitant Therapy. During the study, participants are not allowed to be treated with the following treatments in addition to the study drug: • Antiperistaltic drugs, e.g. loperamide, • Antibiotics • Antipyretics • Intestinal antiseptics, e.g. 8-hydroxyquinoline • Respiratory decongestants, e.g phenylephrine • Antitussive medication, e.g noscapin • Absorbents, e. g. diosmectite, charcoal, pectin, psyllium • Zinc-containing medication • Homemade ORS • ACE Inhibitors • Antispasmodics • Drugs for symptomatic treatment of diarrhea, e.g. pancreatic enzymes, anticholinergic drugs, opiates, diphenoxylate. Subjects on continuous probiotic treatment (e.g. Lactobacillus, Bifidobacterium, yeast) or probiotic- containing supplements/formula of the same product/brand for at least 4 weeks prior to study start can be included. The presence of bloody or purulent stool and fever may indicate either the presence of invasive bacteria as a reason for diarrhea or the presence of another severe disease, warranting causal (e.g. antibiotic) treatment or further investigation. In addition, Racecadotril has not been investigated in patients with antibiotic-associated diarrhea. Therefore, Racecadotril should not be administered under these conditions. Subjects who need treatment with the above listed medication should be withdrawn from the study. Dietary modifications for thickening of the stools are allowed. Any intake of other medication is allowed as judged appropriate by the Investigator except those on the list of prohibited medications above. All medication taken by the subject during the study (from signing the informed consent form through post-study follow-up) is to be recorded on the Concomitant Medication form, except for study drug.
Prior and Concomitant Therapy. During the study, subjects are not allowed to be treated with the following treatments: • Anti-peristaltic drugs, e.g. loperamide • Antibiotics • Antipyretics (suppositories) Oral antipyretics (acetaminophen or ibuprofen) are allowed to be used concomitantly as needed when ear temperature is above 38.3 degrees Celsius, but not longer than two consecutive days during the study. If the fever increases above 39 degrees Celsius with two repeated measurements within one hours, the subject will be withdrawn. • Intestinal antiseptics, e.g. 8-hydroxyquinoline • Respiratory decongestants, e.g. phenylephrine • Antitussive medication, e.g. noscapine Any antitussive drugs, if indicated for pediatric patients, may be given for temporary relief of symptoms as PRN (administration on as needed basis) except those containing opium alkaloids and derivatives (e.g noscapine). • Pre- or Probiotics, e.g. fructooligosaccharides, lactobacilli Subjects on continuous probiotic treatment at study start (e.g. Lactobacillus, Bifidobacterium, yeast) or probiotic-containing supplements/formula of the same product/brand prior to study start can be included. The initiation of pre- or probiotic treatment during the study is forbidden as well as the adaptation of the brand/product or dose. • Absorbents, e. g. diosmectite, charcoal, pectin, psyllium • Zinc-containing medication (other than diaper rash ointments). Diaper rash ointments of any kind are allowed. • Homemade ORS ORS will be provided during the study as judged appropriate by the Investigator. Additional intake of self-purchase or self-made ORS is not allowed during the study duration • ACE Inhibitors • Antispasmodics Antispasmodics, indicated for pediatric patients, may be given for temporary relief of symptoms as PRN (administration on an as needed basis) in exceptional cases. If antispasmodics are needed as daily treatment during the study treatment, the subjects should be discontinued. • Drugs for symptomatic treatment of diarrhea, e.g. pancreatic enzymes, anticholinergic drugs, opiates, diphenoxylate • Intravenous fluid or electrolyte replacement. The presence of bloody or purulent stool and fever above 39 degrees Celsius may indicate either the presence of invasive bacteria as a reason for diarrhea or the presence of another severe disease. In addition, Racecadotril has not been investigated in patients with antibiotic-associated diarrhea. Therefore, Racecadotril should not be administered under these conditions. Subjects who...
