Country: Kanada
Tungumál: enska
Heimild: Health Canada
ACETAMINOPHEN; CODEINE PHOSPHATE
TEVA CANADA LIMITED
N02AJ06
CODEINE AND PARACETAMOL
300MG; 60MG
TABLET
ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 60MG
ORAL
100
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0211376001; AHFS:
APPROVED
2018-10-05
_TEVA-LENOLTEC No. 4 _ _–_ _ Product Monograph_ _Page 1 of 38_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N TEVA-LENOLTEC NO. 4 Acetaminophen and codeine phosphate tablets 300 mg acetaminophen and 60 mg codeine phosphate USP Analgesic-Antipyretic Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9, Canada www.tevacanada.com Submission Control No.:263585 Date of Revision: May 25, 2022 _TEVA-LENOLTEC No. 4 _ _–_ _ Product Monograph_ _Page 2 of 38_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .......................................................... 3 SUMMARY PRODUCT INFORMATION ...........................................................................3 INDICATIONS AND CLINICAL USE.................................................................................3 CONTRAINDICATIONS ....................................................................................................3 WARNINGS AND PRECAUTIONS ....................................................................................4 ADVERSE REACTIONS................................................................................................... 14 DRUG INTERACTIONS ................................................................................................... 16 DOSAGE AND ADMINISTRATION ................................................................................ 17 OVERDOSAGE ................................................................................................................ 20 ACTION AND CLINICAL PHARMACOLOGY ................................................................ 23 STORAGE AND STABILITY ........................................................................................... 25 SPECIAL HANDLING INSTRUCTIONS .......................................................................... 25 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................. 25 PART II: SCIENTIFIC INFORMATION ...................................................................... Lestu allt skjalið