MERSYNDOL WITH CODEINE

1 of the PM Guidance) or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. Recent Major Label Changes...................................................................................................

2 Table of Contents ................................................................................................................... 2 Part 1: Healthcare Professional Information ...........................................................................

4 1 Indications .................................................................................................................. 4 2 Contraindications ........................................................................................................

4 4 Dosage and Administration ......................................................................................... 4 5 Overdose.....................................................................................................................

5 6 Dosage Forms, Strengths, Composition, and Packaging ............................................... 6 7 Warnings and Precautions........................................................................................... 11 8 Adverse Reactions .....................................................................................................

11 9 Drug Interactions ...................................................................................................... 13 10 Clinical Pharmacology ...............................................................................................

15 11 Storage, Stability, and Disposal ................................................................................. 16 Patient Medication Information ...........................................................................................

17 Prescribing Information MERSYNDOL® with codeine Acetaminophen, codeine phosphate and doxylamine succinate tablets Page 4 of 22 Part 1: Healthcare Professional Information 1 Indications MERSYNDOL with codeine is indicated in patients older than 18 years of age for relief of headaches, cold symptoms, muscular aches and pains.

2 Contraindications • Hypersensitivity to acetaminophen, doxylamine, codeine or other opioids, or to any of the non- medicinal ingredients (see 6 Dosage Forms, Strengths, Composition, and Packaging). • Concomitant treatment with Monoamine inhibitors (MAOIs) or treatment within 14 days of stopping MAOIs (see 9 Drug Interactions) • Pre-existing respiratory depression or insufficiency, acute asthma attacks or other chronic lung diseases.

• During last trimester of pregnancy, in the event of impending childbirth, in case of premature birth or breastfeeding (see Error! Reference source not found. Error! , Special Populations, Pregnant Women and Breast-feeding) • Risk of blocked intestines • Head injury • Seizures • Glucose-6-phosphate-dehydrogenase deficiency • Patients for whom it is known they are CYP2D6 ultra-rapid metabolisers • Children (aged below 18 years) who undergo tonsillectomy and/or adenoidectomy to treat obstructive sleep apnea due to an increased risk of developing serious and life-threatening adverse reactions.