TRANEXAMIC ACID

4 Administration 05/2022 7 WARNINGS AND PRECAUTIONS 05/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..............................................................................................

2 TABLE OF CONTENTS................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................

4 1 INDICATIONS ................................................................................................................... 1 Pediatrics...............................................................................................................

2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ......................................................................................................

4 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations ...........................................................................................

2 Recommended Dose and Dosage Adjustment ........................................................ 3 Reconstitution ....................................................................................................... 4 Administration.......................................................................................................

6 5 OVERDOSAGE .................................................................................................................. 7

1 Adverse Reactions Overview Gastrointestinal Disorders: Gastrointestinal symptoms (nausea, vomiting, diarrhea) occur but disappear when the dose is reduced. Immune System Disorders: allergic dermatitis has been reported less commonly.

Nervous System Disorders:

Isolated cases of dizziness or reduced blood pressure have been reported. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

Eye Disorders:

No retinal changes have been reported or observed at ophthalmic check-ups of patients treated with tranexamic acid for several weeks or months. This is despite experimental findings in animals (dog and cat) where retina changes have been observed after long-term administration of large doses of tranexamic acid.

1). 1. 1). 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data No data is available regarding abnormal laboratory findings and tranexamic acid therapy. 5 Post-Market Adverse Reactions Rare cases of adverse events have been reported with the use of tranexamic acid.

Eye Disorders: impaired vision, blurred vision or colour vision impairment (chromatopsia) Immune System Disorders: Cases of allergic reaction with use of intravenous tranexamic acid, including anaphylaxis or anaphylactoid reaction have been reported that are suggestive of a causal relationship.

05/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..............................................................................................

2 TABLE OF CONTENTS................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................

4 1 INDICATIONS ................................................................................................................... 1 Pediatrics...............................................................................................................

2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ......................................................................................................

4 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations ...........................................................................................

2 Recommended Dose and Dosage Adjustment ........................................................ 3 Reconstitution ....................................................................................................... 4 Administration.......................................................................................................

6 5 OVERDOSAGE .................................................................................................................. 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................................... 7 7 WARNINGS AND PRECAUTIONS .......................................................................................