CANESORAL COMBI

2 Recommended Dose and Dosage Adjustment • The recommended dosage of CANESORAL® (fluconazole) for vaginal candidiasis is 150 mg as a single oral dose. • No dosage adjustment required in hepatic or renal impairment. • Use Canesten Extra Strength External Antifungal Cream (clotrimazole) only in conjunction with CANESORAL® Capsules.

The cream should be spread onto the CanesOral® (Fluconazole) CanesOral  Combi 1 Day (Fluconazole and Clotrimazole) Page 5 of 48 irritated area once or twice daily as needed, for up to seven consecutive days. • Vaginal Candidiasis may be accompanied by irritation in the vaginal area.

Therefore, concomitant local treatment with CANESTEN® EXTRA STRENGTH EXTERNAL ANTIFUNGAL CREAM applied to the irritated vaginal area and as far as the anal region twice a day is advisable. CANESTEN® EXTRA STRENGTH EXTERNAL ANTIFUNGAL CREAM applied on the glans penis may prevent re-infection by the partner.

5 Missed Dose Not applicable.

). Brand Name Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients CANESTEN® EXTRA STRENGTH EXTERNAL ANTIFUNGAL CREAM (clotrimazole) topical cream / 2% / clotrimazole benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate and water.

CanesOral® (Fluconazole) CanesOral  Combi 1 Day (Fluconazole and Clotrimazole) Page 7 of 48 Fluconazole administered in combination with ethinyl estradiol- and levonorgestrel-containing oral contraceptives produced an overall mean increase in ethinyl estradiol and levonorgestrel levels; however, in some patients there were decreases up to 47% and 33% of ethinyl estradiol and levonorgestrel levels, respectively (See

1 Pregnant Women 01/2026 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 .................................................................................. 9 8 ADVERSE REACTIONS ................................................................................................

11 9 DRUG INTERACTIONS ................................................................................................ 18 10 CLINICAL PHARMACOLOGY .......................................................................................

20 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 21 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 21 PART II: SCIENTIFIC INFORMATION .......................................................................................

• CANESORAL® (fluconazole) and CANESTEN® EXTRA STRENGTH EXTERNAL ANTIFUNGAL CREAM (clotrimazole) are contraindicated in patients who have shown hypersensitivity to fluconazole, clotrimazole or to any of the excipients used. See the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph for a complete listing of excipients.

There is no information regarding cross hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used by individuals having hypersensitivity to other azoles when using fluconazole. • Co-administration of terfenadine* is contraindicated in patients receiving fluconazole at multiple doses of 400 mg/day or higher based upon results of a multiple-dose interaction study (see 9 DRUG INTERACTIONS).

• Co-administration of cisapride* is contraindicated in patients receiving fluconazole (see 9 DRUG INTERACTIONS). • Co-administration of drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as amiodarone, erythromycin, pimozide and quinidine are contraindicated in patients receiving fluconazole (see 9 DRUG INTERACTIONS).

*not marketed in Canada