Land: Armenien
Språk: engelska
Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pantoprazole (pantoprazole sodium sesquihydrate)
Apotex Inc.
A02BC02
pantoprazole (pantoprazole sodium sesquihydrate)
40mg
tablets enteric-coated
(100) plastic container
Prescription
Registered
2015-03-25
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 Läs hela dokumentet
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 ................................................................................. Läs hela dokumentet