GD-TRANEXAMIC ACID

1 Dosing Considerations  Tranexamic acid blood levels are increased in patients with renal insufficiency. 2 Recommended dose and Dosage Adjustment).  Hypotension may occur after fast injection.  The risk for thromboembolic events may be increased in patients using hormonal contraceptives.

If GD-Tranexamic Acid has to be used in these patients, advise them to use an effective alternative (nonhormonal) contraceptive method. (see 9 DRUG INTERACTIONS). 2 Recommended Dose and Dosage Adjustment  Conization of the cervix: 2-3 tablets (1000-1500 mg) every 8-12 hours, 12 days post operatively  Epistaxis: 2-3 tablets (1000-1500 mg) every 8-12 hours for 10 days  Hyphaema: 2-3 tablets (1000-1500 mg) every 8-12 hours for 7 days  Dental Surgery in Patients with Coagulopathies: 2 hours before the operation, Factor VIII and Factor IX should be given as well as GD-Tranexamic Acid, 25 mg/kg orally.

After the operation, 25 mg/kg GD-Tranexamic Acid is given orally 3-4 times a day for 6-8 days. After the operation the patient does not generally require further substitution therapy.  Menorrhagia (hypermenorrhea): 2-3 tablets (1000-1500 mg), 3-4 times a day for several days.

GD- Tranexamic Acid treatment should only be started when copious bleeding has begun.  Hereditary angioneurotic oedema: Some patients can sense the onset of attacks and are best treated intermittently with 2-3 tablets (1000-1500 mg), 2-3 times a day for several days.

Others should be treated continuously with this dose.  Pediatrics: Dosage should be calculated according to body weight at 25 mg/kg orally, 2-3 times a day. Clinical experience with tranexamic acid in menorrhagic (hypermenorrhea) children under 18 years of age is not available.

 Patients with Impaired Renal Function: In patients with serum creatine concentrations of 120 to 250 μmol/L, the recommended dose is 15 mg/kg orally twice daily. At serum creatine levels of 250 to 500 μmol/L the dosage should be 15 mg/kg orally at 24-hourly intervals, and at serum creatine levels of 500 μmol/L or more, the same dose should be given at intervals of 48 hours between doses.

5 Missed Dose If you forget to take your tablets you should take your next dose as usual. Do not take extra tablets to make up for the missed dose.

1 Adverse Reaction 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.

11/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pregnant Women .......................................................................................... 2 Breast-feeding...............................................................................................

3 Pediatrics ...................................................................................................... 4 Geriatrics ...................................................................................................... 3 Less Common Clinical Trial Adverse Reactions ....................................................

4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ........................................................................................................ 5 Post-Market Adverse Reactions..........................................................................

10 9 DRUG INTERACTIONS.................................................................................................. 2 Drug Interactions Overview................................................................................ 4 Drug-Drug Interactions ......................................................................................

5 Drug-Food Interactions ...................................................................................... 6 Drug-Herb Interactions ...................................................................................... 7 Drug-Laboratory Test Interactions ......................................................................

11 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action.................................................................................... 2 Pharmacodynamics ......................................................................................

11/2022 7 WARNINGS AND PRECAUTIONS 11/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pregnant Women ..........................................................................................

2 Breast-feeding............................................................................................... 3 Pediatrics ...................................................................................................... 4 Geriatrics ......................................................................................................

3 Less Common Clinical Trial Adverse Reactions .................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ........................................................................................................

5 Post-Market Adverse Reactions.......................................................................... 10 9 DRUG INTERACTIONS.................................................................................................. 2 Drug Interactions Overview................................................................................

4 Drug-Drug Interactions ...................................................................................... 5 Drug-Food Interactions ...................................................................................... 6 Drug-Herb Interactions ......................................................................................

7 Drug-Laboratory Test Interactions ...................................................................... 11 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action....................................................................................