SALOFALK

2 Recommended Dose and Dosage Adjustment • One 500 mg SALOFALK rectal suppository is self-administered on a twice a day or three times a day basis. One 1000 mg SALOFALK rectal suppository is self-administered on a once daily basis, at bedtime.

5 g/day and dosing is continued until a significant response is achieved or until the patient achieves remission. Dose tapering is recommended. Abrupt discontinuation is not recommended. Best results are expected with prolonged retention.

Health Canada has not authorized an indication for pediatric use. 1 Pediatrics. 4 Administration For rectal use only. SALOFALK suppositories are self-administered, one 500 mg suppository 2 or 3 times/day, and one 1000 mg suppository 1 time daily at bedtime.

The suppository should be retained SALOFALK (mesalamine suppositories) Page 5 of 25 for 1 to 3 hours or longer to achieve the maximum benefit. While the effect of the suppositories may be seen within 3 to 21 days, the usual course of therapy would be from 3 to 6 weeks depending on symptoms and sigmoidoscopic findings.

Patient Instructions:

I. Detach one suppository from the strip of suppositories. II. Hold suppository upright and carefully remove the plastic wrapper. III. Avoid excessive handling of suppository, which is designed to melt at body temperature. IV. Insert suppository completely into rectum with gentle pressure, pointed end first.

V. A small amount of lubricating gel may be used on the tip of the suppository to assist insertion. In children, information on the safety and efficacy of mesalamine suppositories is limited. Therefore, use should be limited to situations where a clear benefit is expected.

5 Missed Dose If a dose of SALOFALK is missed, it should be used as soon as possible, unless it is almost time for the next dose. A patient should not use two doses at the same time to make up for a missed dose.

1 Adverse Reaction Overview Hypersensitivity reactions have been reported in a sub-group of patients known to be allergic to sulfasalazine including rash, pyrexia, and dizziness with reactions occurring at the onset of therapy and resolving promptly following discontinuation.

Other manifestations of hypersensitivity reported with mesalamine include acute pancreatitis, hepatitis, pericarditis, interstitial nephritis, interstitial pneumonia and pleural effusion. Interstitial pneumonia, pancreatitis and pericarditis have also been reported as manifestations of inflammatory bowel disease.

As with all 5-ASA products, exacerbations of ulcerative colitis characterized by cramping acute abdominal pain and diarrhoea have been reported with mesalamine. Other reported side effects include headache, flatulence, nausea, and hair loss, but do not appear to be common.

Retreatment is not always associated with repeated hair loss. Aplastic anaemia has been reported in the literature with unspecified formulations of mesalamine. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.

The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to SALOFALK (mesalamine suppositories) Page 9 of 25 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 the post-approval use of SALOFALK.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

2 Breast Feeding 11/2021 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................................................................................ 2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration .........................................................................................................

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

5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 5 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations ..................................................................................................

SALOFALK 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.

73m2) and/or severe hepatic impairment. See 7 WARNINGS AND PRECAUTIONS. • cases of existing gastric or duodenal ulcer. • patients with urinary tract obstructions. g. Aspirin®), may also be hypersensitive to this medication.