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

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

Sucrose
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

05/09/2011

Drugs

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

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.