MESALAMINE

1 Dosing Considerations Patients with ulcerative colitis should be made aware that ulcerative colitis rarely remits completely. Abrupt discontinuation of MESALAMINE (800 mg tablet) is not recommended, and may result in relapse. It is important for patients to comply with the dosage prescribed by their doctors; by doing so, the risk of relapse can be substantially reduced.

8 g), taken orally once daily or in divided doses with or without food. Geriatrics (≥65 years) The normal adult dose can be taken unless hepatic or renal function is severely impaired (see 2 CONTRAINDICATIONS, and 7 WARNINGS AND PRECAUTIONS).

No clinical studies have been carried out in geriatric population. Health Canada has not authorized an indication for pediatric use. 4 Administration  Swallow tablets whole, taking care not to break the outer coating. The outer coating is designed to remain intact, to protect the active ingredient until it reaches the terminal ileum, where the tablet coating dissolves and the contents of the tablet are released into the terminal ileum and colon.

 Take MESALAMINE (800 mg tablet) tablets only as prescribed. Do not change the number or frequency of tablets ingested without first consulting your physician.  What appears to be intact or partially intact tablets may infrequently appear in the stool.

If this occurs repeatedly, consult your physician. 5 Missed Dose If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.

Do not take double the dose.

1 Adverse Reaction Overview MESALAMINE is generally well tolerated. Organ specific adverse drug reactions affecting the heart, lungs, liver, kidneys, pancreas, skin and subcutaneous tissue have been reported. Treatment must be MESALAMINE (Delayed-Release Tablets) Page 10 of 26 stopped immediately if acute symptoms of intolerance occur such as abdominal cramps, acute abdominal pain, fever, severe headache and rash.

The most commonly reported adverse reactions were ulcerative colitis followed by haematuria and ketonuria. 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 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. MESALAMINE 800 mg delayed-release tablets have been evaluated in 140 patients with mild to moderate active ulcerative colitis in one controlled study lasting for 10 weeks comparing safety and efficacy versus placebo.

1%). Table 2 enumerates treatment related adverse reactions that occurred at a frequency of ≥1% in the MESALAMINE and placebo treated groups. All adverse reactions associated with the use of MESALAMINE 800 mg delayed-release tablets were of mild to moderate severity.

3% of patients in the placebo group. Most of the drug related adverse reactions that led to study drug discontinuation were related to worsening of ulcerative colitis. 5 Post-Market Adverse Reactions In addition to the adverse events reported above in the clinical trial involving MESALAMINE, the following adverse events have been reported in literature reports, or foreign and domestic marketing experience with MESALAMINE or other products that contain or are metabolized to mesalamine.

73 m2); see 7 WARNINGS AND PRECAUTIONS  Patients with existing gastric or duodenal ulcer  Have urinary tract obstruction  Are unable to swallow the intact tablet MESALAMINE (Delayed-Release Tablets) Page 5 of 26 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions  History of adverse drug reactions to sulfasalazine: Patients with a history of adverse drug reactions to sulfasalazine therapy should be kept under close medical supervision.

Treatment must be stopped immediately if acute symptoms of intolerance occur such as abdominal cramps, acute abdominal pain, fever, severe headache and rash.  Blood system: Serious blood dyscrasia has very rarely been reported. MESALAMINE therapy should be stopped immediately if there is a suspicion or evidence of blood dyscrasia (signs of unexplained bleeding, bruising, purpura, anemia, persistent fever or sore throat), and patients should seek immediate medical advice.

It is recommended that hematological investigations (differential blood count) are performed prior to initiation of MESALAMINE and whilst on therapy, at the discretion of the treating physician. As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks.

If the findings are normal, follow-up tests should be carried out every 3 months. If additional symptoms occur, these tests should be performed immediately.  Renal: Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and renal failure has been reported in patients taking mesalamine products.

Urinary status (dip sticks) should be determined prior to and during treatment, at the discretion of the treating physician. Caution should be exercised in patients with raised serum creatinine or proteinuria. The possibility of mesalamine-induced nephrotoxicity should be suspected in patients developing impairment of renal function during treatment.

MESALAMINE (800 mg tablet) 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.

73 m2); see 7 WARNINGS AND PRECAUTIONS  Patients with existing gastric or duodenal ulcer  Have urinary tract obstruction  Are unable to swallow the intact tablet MESALAMINE (Delayed-Release Tablets) Page 5 of 26