Salofalk (Mesalamine) – Generic


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Salofalk (Mesalamine) Dosage and Side Effects

SALOFALK tablets are used for the treatment of acute ulcerative colitis (inflammation of the lining of the large bowel and rectum) and in the prevention of relapse of Crohn’s disease in patients following bowel resection.

Warnings and Precautions

BEFORE you use SALOFALK 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 have pyloric stenosis (a narrowing of the outlet from the stomach that causes contents of the stomach to remain there for a longer period of time). Pyloric stenosis may keep the SALOFALK tablet from reaching the colon as quickly as it normally would.
    • You are pregnant or breastfeeding. Mesalamine is excreted in human breast milk. Discuss with your doctor.


  • 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 SALOFALK may damage your kidneys.

Side Effects

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 SALOFALK tablets include abdominal pain or discomfort, abnormal coloration of the urine, back and neck pain, cough, diarrhoea, dizziness, flatulence, fever, burning or tingling sensation in the mouth, hair loss, headache, itching, inflammation of heart muscle, nausea, kidney stones, rash, stools discoloured, tiredness, tongue discoloration and tongue swelling.

Proper Use of this medication

Usual adult dose:

For the treatment of acute ulcerative colitis: Two 500 mg SALOFALK tablets, three or four times daily.

For the prevention of recurrence of Crohn’s disease in patients following bowel resection: 3 g/day in divided doses.

Tablets should be taken consistently for treatment success.

Tablets should be swallowed whole before meals with liquid. Do not crush the tablets. Abrupt discontinuation is not recommended.


If you believe you have taken too many tablets, 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 SALOFALK, take your dose as soon as possible, unless it is almost time for the next dose. Do not take two SALOFALK doses at the same time to make up for a missed dose.

Interactions with this medication

Interaction between azathioprine, 6-mercaptopurine and aminosalicylates (such as SALOFALK) 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.