HIDRASEC

This brand name is authorized in Nigeria. It is also authorized in Austria, Croatia, Ecuador, Estonia, Finland, Hong Kong SAR China, Ireland, Lithuania, Mexico, Poland, Romania, Singapore, Spain.

Active ingredients

The drug HIDRASEC contains one active pharmaceutical ingredient (API):

1	Racecadotril UNII 76K53XP4TO - 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.
	Read more about Racecadotril

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
B4-7102	Granules for suspension	HIDRASEC GRANULES FOR ORAL SUSPENSION (CHILDREN) GRAN_F_SUSP 30 mg 1x30,8X2	HIDRASEC GRANULES FOR ORAL SUSPENSION (CHILDREN) RACECADOTRIL RACECADOTRIL 30MG.EXCIPIENTS;Surcrose ,collodial anhydrous silica ,dispersion of polyacrylate B4-7102 Drugs Imported Products 1x30,8X2 Prescription Only Medicine (POM) 13/04/2022 PHILLIPS PHARMACEUTICALS (NIGERIA) LTD, APAPA-OSHODI EXPRESSWAY, IYANA-ISOLO LAGOS LAGOS 8035493198 samson.omattah@phillipsnigeria.com LABORATORIES SOPHARTEX , LABORATORIES SOPHARTEX 21 RUE DU PRESSOIR 28500 VERNOUILLET ,FRANCE, France	26/04/2023
B4-7103	Granules for suspension	HIDRASEC GRANULES FOR ORAL SUSPENSION (INFANT) 10MG GRAN_F_SUSP 10 mg 1X16	HIDRASEC GRANULES FOR ORAL SUSPENSION (INFANT) 10MG RACECADOTRIL 10mg RACECADOTRIL 10mg, Excipient:Sucrose,anhydrous collodical silica,polyacrylate dispersion apricot flavour. B4-7103 Drugs Imported Products 1X16 Prescription Only Medicine (POM) 20/04/2022 PHILLIPS PHARMACEUTICALS (NIGERIA) LTD, APAPA-OSHODI EXPRESSWAY, IYANA-ISOLO LAGOS LAGOS 8035493198 samson.omattah@phillipsnigeria.com LABORATORIES SOPHARTEX , LABORATORIES SOPHARTEX 21 RUE DU PRESSOIR 28500 VERNOUILLET ,FRANCE, France	26/04/2023
B4-7104	Capsule	HIDRASEC CAPSULE 100MG CAP 100 mg 1X20	HIDRASEC CAPSULE 100MG RACECADOTRIL Racecadotril 100mg,,lacyulose maize magnesuim sterate collodial silica B4-7104 Drugs Imported Products 1X20 Prescription Only Medicine (POM) 13/04/2022 PHILLIPS PHARMACEUTICALS (NIGERIA) LTD, APAPA-OSHODI EXPRESSWAY, IYANA-ISOLO LAGOS LAGOS 8035493198 samson.omattah@phillipsnigeria.com LABORATORIES SOPHARTEX , LABORATORIES SOPHARTEX 21 RUE DU PRESSOIR 28500 VERNOUILLET ,FRANCE, France	26/04/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
HIDRASEC Granules for oral suspension	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
A07XA04	Racecadotril	A Alimentary tract and metabolism → A07 Antidiarrheals, intestinal antiinflammatory/antiinfective agents → A07X Other antidiarrheals → A07XA Other antidiarrheals
Discover more medicines within A07XA04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	25.861-08-04, 5452-MAE-04-09, 5453-MAE-04-09
EE	Ravimiamet	1520536, 1520547, 1520558, 1520581, 1520592, 1520604, 1520659, 1520660, 1520671, 1520682, 1520693, 1520705, 1520749, 1520772, 1520839, 1520840, 1558492
ES	Centro de información online de medicamentos de la AEMPS	77809
FI	Lääkealan turvallisuus- ja kehittämiskeskus	091446, 097504, 418942, 513253
HK	Department of Health Drug Office	59223, 59227, 59228
HR	Agencija za lijekove i medicinske proizvode	HR-H-006305834, HR-H-113623607, HR-H-944929327
LT	Valstybinė vaistų kontrolės tarnyba	1059232, 1059236, 1059237, 1065086, 1065087, 1065088, 1065089, 1065090, 1065091, 1065092, 1065093, 1065094, 1065095, 1065218, 1065219, 1065220, 1065423, 1088981
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	125M2000, 594M98
NG	Registered Drug Product Database	B4-7102, B4-7103, B4-7104
PL	Rejestru Produktów Leczniczych	100263647, 100263653, 100345575, 100359838, 100425713, 100464591
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W63748001, W63748002, W63748003, W63748004, W63748005, W63748006, W63749001, W63749002, W63749003, W63749004, W63749005, W63749006, W63750001, W63750002
SG	Health Sciences Authority	14412P, 14413P