Apo-Pantoprazole 20mg tablets enteric-coated

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

pantoprazole (pantoprazole sodium sesquihydrate)

Beschikbaar vanaf:

Apotex Inc.

ATC-code:

A02BC02

INN (Algemene Internationale Benaming):

pantoprazole (pantoprazole sodium sesquihydrate)

Dosering:

20mg

farmaceutische vorm:

tablets enteric-coated

Eenheden in pakket:

(100) plastic container

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2015-03-25

Bijsluiter

IMPORTANT: PLEASE READ
Page 36 of 38
PART III: CONSUMER INFORMATION
APO-PANTOPRAZOLE
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS USP
20 MG AND 40 MG PANTOPRAZOLE (AS PANTOPRAZOLE SODIUM)
THIS LEAFLET IS PART III OF A THREE-PART “PRODUCT
MONOGRAPH” PUBLISHED WHEN APO-PANTOPRAZOLE
WAS APPROVED FOR SALE IN CANADA AND IS DESIGNED
SPECIFICALLY FOR CONSUMERS. THIS LEAFLET IS A SUMMARY AND
WILL NOT TELL YOU EVERYTHING ABOUT APO-
PANTOPRAZOLE, CONTACT YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT THE DRUG.
ABOUT THIS MEDICATION
WHAT THE MEDICATION IS USED FOR:
APO-PANTOPRAZOLE is used to treat acid-related stomach
problems such as stomach ulcers (also known as gastric
ulcers), duodenal ulcers, reflux esophagitis (a severe form of
heartburn), symptoms of gastro-esophageal reflux disease
(heartburn and acid regurgitation), and the prevention of
gastrointestinal damage (such as erosions and/or ulcers in the
stomach/duodenum) and symptoms caused by non-steroidal
anti-inflammatory drugs [(NSAIDs) medicines commonly
used to treat arthritis and certain muscle conditions] when
individuals must continue to take NSAIDs and where these
individuals are considered to have an increased risk of
developing gastrointestinal damage.
WHAT IT DOES:
APO-PANTOPRAZOLE works by reducing the amount of
acid made in your stomach.
WHEN IT SHOULD NOT BE USED:
You should not take APO-PANTOPRAZOLE if you think you
might be allergic to any of the ingredients (see "What the non-
medicinal ingredients are").
WHAT THE MEDICINAL INGREDIENT IS:
pantoprazole sodium
WHAT THE NON-MEDICINAL INGREDIENTS ARE:
APO-PANTOPRAZOLE 20 mg and 40 mg tablets contains
the following non-medicinal ingredients: anhydrous lactose,
crospovidone, hydroxypropyl methylcellulose, magnesium
stearate, methacrylic acid copolymer, microcrystalline
cellulose, polyethylene glycol, purified water, sodium
carbonate anhydrous, talc, titanium dioxide, triethyl citrate and
yellow ferric oxide.
WHAT DOSAGE FORMS IT COMES IN:
enteric-coated tablet, 20 mg and 40 mg pantoprazole
A

Productkenmerken

Page 1 of 38
PRODUCT MONOGRAPH
APO-PANTOPRAZOLE
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS USP
20 MG AND 40 MG PANTOPRAZOLE (AS PANTOPRAZOLE SODIUM)
H
+
, K
+
-ATPASE INHIBITOR
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
TORONTO, ONTARIO
SEPTEMBER 2, 2015
M9L 1T9
Page 2 of 38
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......................................................................................................6
DRUG
INTERACTIONS....................................................................................................10
DOSAGE AND
ADMINISTRATION.................................................................................11
OVERDOSAGE
..................................................................................................................12
ACTION AND CLINICAL
PHARMACOLOGY................................................................12
STORAGE AND
STABILITY............................................................................................14
SPECIAL HANDLING INSTRUCTIONS
..........................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................14
PART II: SCIENTIFIC
INFORMATION............................................................................16
PHARMACEUTICAL INFORMATION
............................................................................16
CLINICAL TRIALS
.................................................................................