Canasa Suppositories (Mesalamine)

BEFORE you use CANASA talk to your doctor or pharmacist if:

• You have a pre-existing liver disease. There have been reports of hepatic failure and increased liver enzymes in patients treated with 5-ASA or mesalazine (= mesalamine) products
• You have mild to moderate liver function impairment. Your doctor will decide if this product is right for you
• You ever had any unusual or allergic reaction to mesalamine (5-ASA), sulfasalazine (SAS), or salicylates (Aspirin)
• You have liver or kidney disease
• You have bleeding or clotting disorders
• Your doctor has said you have higher than normal blood urea nitrogen (BUN) levels (renal function test)
• You are pregnant or breastfeeding. Mesalamine is excreted in human breast milk. Discuss with your doctor.

WHILE using CANASA:

• Discontinue use at first sign of rash or fever.

You may have your blood or urine tested regularly to monitor your kidney function since prolonged use of CANASA may damage your kidneys.

Interaction between azathioprine, 6-mercaptopurine and aminosalicylates (such as CANASA) has been reported.

Drug interactions with coumarin, methotrexate, probenecid, sulfinpyrazone, spironolactone, furosemide, rifampicin and Varicella Virus Vaccine (chicken pox vaccine) may be possible.

Possible interference with measurements, by liquid chromatography, of urinary normetanephrine causing a false-positive test result have been observed in patients exposed to sulfasalazine or its metabolite, mesalamine/mesalazine.

Usual adult dose:

One 500 mg CANASA suppository is self-administered on a twice a day or three times a day basis. One 1000 mg CANASA suppository is self-administered on a once daily basis, at bedtime. The usual adult dose is 1.0-1.5 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.

The suppository should be retained in the rectum for one to three hours or longer, if possible, to achieve the maximum benefit.

How to use CANASA suppositories:

NOTE: CANASA suppositories will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel.

Patient Instructions:

• Detach one suppository from the strip of suppositories.
• Hold suppository upright and carefully remove the plastic wrapper.
• Avoid excessive handling of suppository, which is designed to melt at body temperature.
• Insert suppository completely into rectum with gentle pressure, pointed end first.
• A small amount of lubricating gel may be used on the tip of the suppository to assist insertion.

Overdose:

If you believe you have used too much, or in case of accidental oral ingestion, contact your doctor, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose of CANASA, use it as soon as possible, unless it is almost time for the next dose. Do not use two CANASA suppositories at the same time to make up for a missed dose.

Rash, fever, and dizziness are common in patients allergic to sulfasalazine. Stop therapy at the first sign of a rash and contact your doctor.

Worsening of ulcerative colitis may occur and may include the following symptoms: abdominal or stomach cramps or pain (severe) and diarrhoea.

Other reported side effects reported with CANASA suppositories include abdominal cramps, abdominal pain or discomfort, anal itching, anorectal discomfort, bloating, constipation, cough, diarrhoea, dizziness, flatulence, fever, frequent bowel movements, hair loss, headache, itching, lower back pain, mucus in stools, nausea, pain, painful bowel movements, rash, rectal discharge, rectal pain, stools discoloured and vomiting.

For any unexpected effects while taking CANASA, contact your doctor or pharmacist.