Expert committee gives green light: Active ingredient racecadotril available over the counter for children 12 years and older

14.01.2015 16:36

The German Expert Committee on Prescription Only of the Federal Institute for Drugs and Medical Devices (BfArM) today approved the removal of the active ingredient racecadotril from prescription-only medicines for children and adolescents.

The drug is expected to be available for the new target group in German pharmacies under the umbrella brand Vaprino® before the end of this year, provided the Federal Ministry of Health endorses the decision and the German Federal Council approves the amendments to the German Drug Prescription Ordinance. "This positive decision is an important step so that children and adolescents can also benefit from the effective effects and good tolerability of racecadotril in self-medication in the future," explains Patricia Alison Hartley, Head of Self-Medication at Boehringer Ingelheim in Germany.

Racecadotril, the active ingredient in Vaprino®, reduces excessive fluid inflow into the intestines, allowing bowel function to return to normal within a short period of time without inhibiting intestinal motility. This allows pathogens to continue to be excreted. Diarrhea medications containing the active ingredient racecadotril have been available in Germany since 2004. In 2013, at the request of Boehringer Ingelheim, the active ingredient was no longer subject to prescription; in June 2013, the company launched Vaprino® for acute diarrhea on the German market. To date, almost 45 million children worldwide have been treated with prescription racecadotril granules.

The new Vaprino® product will be available over the counter for children aged 12 and over. The maximum duration of use for self-medication will be three days.

Boehringer Ingelheim is a global leader in self-medication, particularly for diseases of the gastrointestinal tract and for the treatment of cold symptoms.