LOCACORTEN VIOFORM EARDROPS

1 Dosing Considerations • Thorough cleansing of the external ear is essential for successful treatment. If a large amount of discharge is present, the meatus may initially require gentle syringing. Thereafter, the passage may be kept clean by wiping as necessary.

LOCACORTEN VIOFORM EARDROPS (flumethasone pivalate and clioquinol drops) Page 5 of 15 • Free drainage of the ear encourages healing. However, in severe cases, it may be desirable to pack the ear lightly with a gauze strip moistened with the solution, replacing this dressing as necessary, at least once every 24 hours.

• Prior to beginning therapy, the eardrum should be checked by a healthcare professional. LOCACORTEN VIOFORM EARDROPS should not be used if there is a risk that perforation of the eardrum may occur or has occurred. 2 Recommended Dose and Dosage Adjustment Two to three drops of LOCACORTEN VIOFORM EARDROPS should be instilled twice daily.

Treatment should normally not exceed 10 days. If no improvement occurs within 1 week, therapy should be discontinued. The pathogens should then be identified and treated. 4 Administration • The solution may be warmed to body temperature prior to application by holding the bottle in the hands.

Heating above body temperature should be avoided • To ensure correct administration of the drug, the patient or another person should be instructed both on how to clean the outer ear and apply the eardrops. The patient should be either sitting or lying down with the treated ear turned upwards during application.

This position should be maintained for 1-2 minutes following the application. • To avoid contamination of the eardrops, contact of the dropper with any surface (including the ear) should be avoided. • LOCACORTEN VIOFORM EARDROPS may turn yellow when exposed to air and may cause staining of the skin, nails, hair or fabrics.

5 OVERDOSE Poisoning due to accidental ingestion is not expected since a bottle of LOCACORTEN VIOFORM EARDROPS contains far less active ingredients than the upper safe limit of a single oral dose for either component. 7 Drug-Laboratory Test Interaction.

If signs and symptoms resembling those if thyrotoxicosis occur, the preparation should be withdrawn at once. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1- 844-764-7669).

1 Adverse Reaction Overview Occasionally: Signs of irritation such as burning sensation, itching or skin rash at the site of application; hypersensitivity reactions. If an exacerbation or allergic type reaction occurs, treatment with LOCACORTEN VIOFORM EARDROPS should be discontinued.

2 Clinical Trial Adverse Reactions In human toxicity and absorption studies no systemic or pituitary-adrenal effects were noted. The only significant abnormalities found were elevated 17-ketosteroid levels and elevated serum protein-bound iodine (PBI) levels following topical administration.

No systemic toxic effects due to absorption of LOCACORTEN VIOFORM EARDROPS from the auditory canal were reported in clinical trials. , 90 g per day for 7 days over the entire body with about half the skin occluded at all times. LOCACORTEN VIOFORM EARDROPS (flumethasone pivalate and clioquinol drops) Page 8 of 15

, Sensitivity/Resistance 2025-04 TABLE OF CONTENTS Certain sections 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 I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................

4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 5 OVERDOSE ..................................................................................................................

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

7 9 DRUG INTERACTIONS .................................................................................................. 8 10 CLINICAL PHARMACOLOGY .........................................................................................

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

, chicken pox) or syphilitic skin infections, tuberculosis of the skin or skin eruptions following vaccination • patients with known hypersensitivity to flumethasone pivalate or to corticosteroids in general, to hydroxyquinolines, clioquinol, or other quinoline derivatives, iodine, as well as to any other components of LOCACORTEN VIOFORM EARDROPS including any non- medicinal ingredient or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • application to the eye • use in children under 2 years of age