DIARRHEA RELIEF TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

LOPERAMIDE HYDROCHLORIDE

Commercializzato da:

PHARMASCIENCE INC

Codice ATC:

A07DA03

INN (Nome Internazionale):

LOPERAMIDE

Dosaggio:

2MG

Forma farmaceutica:

TABLET

Composizione:

LOPERAMIDE HYDROCHLORIDE 2MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

OTC

Area terapeutica:

ANTIDIARRHEA AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0111332001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2004-01-29

Scheda tecnica

PRODUCT MONOGRAPH
DIARRHEA RELIEF
Loperamide Hydrochloride Tablets, USP
Caplets: 2 mg
ORAL ANTIDIARRHEAL AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
October 4, 2019
PMS VERSION 1:
December 17, 2018
PMS VERSION 2:
June 17, 2019
SUBMISSION CONTROL NO: 231514
_DIARRHEA RELIEF Product Monograph _
_Page 2 of 31_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................14
SPECIAL HANDLING INSTRUCTIONS
.......................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
................................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL