HIDRASEC Granules for oral suspension Ref.[8287] Active ingredients: Racecadotril

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Bioprojet Europe Ltd., 29 Earlsfort Terrace, EI-Dublin 2, IRELAND

Product name and form

Hidrasec 10 mg, Granules for oral suspension.

Pharmaceutical Form

Granules for oral suspension.

White powder with characteristic apricot smell.

Qualitative and quantitative composition

Each sachet contains 10 mg of racecadotril.

Each sachet contains 966.5 mg of sucrose.

For a full list of excipients, see section 6.1.

Active Ingredient Description

Racecadotril is a pure intestinal antisecretory active substance. It decreases the intestinal hypersecretion of water and electrolytes induced by the cholera toxin or inflammation, and does not have effects on basal secretory activity. Racecadotril exerts rapid antidiarrhoeal action, without modifying the duration of intestinal transit.

List of Excipients

Anhydrous colloidal silica
Polyacrylate dispersion 30 per cent
Apricot aroma

Pack sizes and marketing

Thermowelded paper/aluminium/polyethylene sachets.

Packs containing 10, 16, 20, 30, 50 and 100 sachets (100 sachets only for hospital use).

Not all pack sizes may be marketed.

Marketing authorization holder

Bioprojet Europe Ltd., 29 Earlsfort Terrace, EI-Dublin 2, IRELAND

Marketing authorization dates and numbers

PL 39418/0001



Drug Countries
HIDRASEC Austria, Ecuador, Estonia, Spain, Finland, Hong Kong, Ireland, Lithuania, Mexico, Poland, Romania, Singapore

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