JAMP KETOTIFEN

1 Special Populations 03/2025 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 ........................................................... 4 Administration ............................................................................................................ 5 Missed Dose ................................................................................................................

4 5 OVERDOSAGE................................................................................................................ 5

0%. 5%. The occurrence of these side effects were generally mild and did not result in discontinuation or interruption of trial medication. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most frequently reported ocular adverse reaction was conjunctival hyperemia and the most common non-ocular adverse reaction was headache (Table 2). 3 Less Common Clinical Trial Adverse Reactions The less common adverse reactions (<1%) are presented below.

5 Post-Market Adverse Reactions The following post marketing events have also been observed (frequency not known): Eye disorders: punctate keratitis, punctate corneal epithelial erosion, vision blurred (during installation) and conjunctival haemorrhage Gastrointestinal disorders: dry mouth Immune system disorders: hypersensitivity Hypersensitivity reactions including local allergic reaction (mostly contact dermatitis, eye swelling, eyelid pruritis and oedema), systemic allergic reactions including facial swelling/oedema (in some cases associated with contact dermatitis) and exacerbation of pre- existing allergic conditions such as asthma and eczema.

Nervous system disorders: dizziness Skin and subcutaneous tissue disorders: eczema, urticaria JAMP Ketotifen (Ketotifen Fumarate Ophthalmic Solution) Page 8 of 17

1 Special Populations 03/2025 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 ........................................................... 4 Administration ............................................................................................................ 5 Missed Dose ................................................................................................................

4 5 OVERDOSAGE................................................................................................................ 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 5 7 WARNINGS AND PRECAUTIONS .....................................................................................

• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph.