MINT-CELECOXIB

1 Dosing Considerations Use of MINT-CELECOXIB should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).

g. hypertension, hyperlipidemia, diabetes mellitus and smoking) (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX). 2 Recommended Dose and Dosage Adjustment Osteoarthritis: The recommended daily dose of MINT-CELECOXIB is 200 mg administered as a single dose or as two divided doses (100 mg twice per day).

Maximum dose = 200 mg a day.

Rheumatoid Arthritis:

The recommended starting dose of MINT-CELECOXIB is 100 mg twice per day, which may be increased to 200 mg twice per day if necessary. Maximum dose = 200 mg twice a day.

Ankylosing Spondylitis:

The recommended daily dose of MINT-CELECOXIB is 200 mg administered as a single dose or as two divided doses (100 mg twice a day). Maximum dose = 200 mg a day.

Management of Acute Pain:

The recommended dose of MINT-CELECOXIB is 400 mg as a single dose on the first day followed by 200 mg once daily on subsequent days up to a maximum of 7 days. Patients may be instructed to take an additional dose of 200 mg on any given day, if needed.

Maximum dose = 400 mg a day for up to 7 days.

Pediatrics (< 18 years of age):

Health Canada has not authorized an indication for pediatric use.

See 2 CONTRAINDICATIONS Hepatic Impairment:

MINT-CELECOXIB capsules should be introduced at the lowest dose in patients with mild hepatic impairment (Child-Pugh 5-6). 3 Pharmacokinetics, Special Populations and Conditions). MINT-CELECOXIB is contraindicated in patients with severe hepatic impairment (Child- Pugh > 9) (see 2 CONTRAINDICATIONS).

3 Pharmacokinetics, Special Populations and Conditions). MINT-CELECOXIB is contra- indicated in patients with severe renal impairment (estimated creatinine clearance < 30 mL/min) (see 2 CONTRAINDICATIONS). 4 Geriatrics).

). 1 Adverse Reaction Overview).

CYP2C9 Poor Metabolizers:

Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution. MINT-CELECOXIB should be introduced at half the lowest recommended dose in CYP2C9 poor metabolizers, with a maximum recommended dose of 100 mg daily (see

, Skin, Serious skin reactions 07/2025 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..............................................................................................................

5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ....................................................................... 6 4 DOSAGE AND ADMINISTRATION .............................................................................................

1 Dosing Considerations .................................................................................................... 2 Recommended Dose and Dosage Adjustment ................................................................ 4 Administration ...............................................................................................................

5 Missed Dose................................................................................................................... 8 5 OVERDOSAGE ..........................................................................................................................

and 7 WARNINGS AND PRECAUTIONS). For patients with an increased risk of developing gastrointestinal adverse events, other management strategies that do NOT include the use of NSAIDs, including MINT-CELECOXIB, should be considered first (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).

Use of MINT-CELECOXIB should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).

MINT-CELECOXIB, as a NSAID, does NOT treat clinical disease or prevent its progression. MINT-CELECOXIB, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it. 1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of celecoxib capsules in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.

(see 2 CONTRAINDICATIONS). 4 Geriatrics). MINT-CELECOXIB (celecoxib) Page 5 of 58 Protected B / Protégé B 2 CONTRAINDICATIONS MINT-CELECOXIB is contraindicated in: • The peri-operative setting of Coronary Artery Bypass Graft Surgery (CABG).

Although celecoxib capsules has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections and sternal wound complications (see 14 CLINICAL TRIALS, Cardiovascular Safety- Meta- analysis from Chronic Usage Studies).

• The third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus and prolonged parturition. • Women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants. • Severe uncontrolled heart failure.