FML

1 Dosing Considerations • The dosing of FML may be reduced, but care should be taken not to discontinue therapy prematurely. If FML is used for longer than 10 days (see 7 WARNINGS AND PRECAUTIONS), withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

2 Recommended Dose and Dosage Adjustment • FML is for topical ophthalmic use only. Shake fluorometholone ophthalmic suspension well before use. • Instill 1 to 2 drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be safely increased to 2 drops every 4 hours.

Care should be taken not to discontinue therapy prematurely. FML (Fluorometholone) Page 5 of 18 • If signs and symptoms fail to improve after two days, the patient should be re-evaluated. Health Canada has not authorized an indication for pediatric use.

Health Canada has not authorized an indication for geriatric use. 4 Administration To prevent eye injury or contamination, care should be taken to avoid touching the bottle to the eye, the eyelids or to any other surface. The use of the bottle by more than one person may spread infection.

5 Missed Dose If the patient forgets to apply eye drops at their normal time, instruct the patient to apply them as soon as they remember. Instruct the patient to then return to their original schedule. Instruct the patient not to catch up on missed drops by applying more than one dose at a time.

1 Adverse Reaction Overview Ocular adverse reactions associated with ophthalmic steroids may include elevated IOP, which may be associated with optic nerve damage, loss of visual acuity and field of vison defects, posterior subcapsular cataract formation, secondary ocular infection, delayed wound healing (including perforation of the globe where there is thinning of the cornea or sclera).

Eye disorders: posterior subcapsular cataract formation, secondary ocular infection from pathogens liberated from ocular tissues, and perforations of the globe. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.

Therefore, the adverse reaction rates observed in the clinical trials, 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.

5 Post-Market Adverse Reactions The following adverse reactions have been identified during post marketing use of FML in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

Eye disorders: eye irritation, conjunctival/ocular hyperemia, visual disturbance, foreign body sensation, eyelid edema, blurred vision, eye discharge, eye pruritis, lacrimation increased, eye edema/eye swelling, mydriasis, ulcerative keratitis, ocular infection (including bacterial, fungal, and viral infections), visual field defect, punctate keratitis, eyelid ptosis.

Cases of corneal calcification have been reported very rarely in association with the phosphate component of FML in some patients with significantly damaged corneas. Immune system disorders: hypersensitivity and allergic reactions Gastrointestinal Disorders: dysgeusia Skin and subcutaneous tissue disorders: rash

, Class Effects 07/2024 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 ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................

4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 5 OVERDOSAGE..............................................................................................................

5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 5 7 WARNINGS AND PRECAUTIONS .................................................................................. 8 8 ADVERSE REACTIONS ..................................................................................................

8 FML (Fluorometholone) Page 3 of 18 9 DRUG INTERACTIONS .................................................................................................. 9 10 CLINICAL PHARMACOLOGY .........................................................................................

9 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 10 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 10 PART II: SCIENTIFIC INFORMATION .......................................................................................

FML is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

FML is contraindicated in: • Superficial (or epithelial) herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and other viral diseases of the cornea and conjunctiva. , Tuberculosis of the eye) • Acute untreated infections of the eye • Patients who are hypersensitive to other corticosteroids.