Saloflak - Consumer Medicine Information
|Condition:||Crohn's Disease, Maintenance, Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis, Ulcerative Colitis, Active, Ulcerative Colitis, Maintenance, Ulcerative Proctitis|
|Ingredients:||mesalamine, carnauba wax, colloidal silicon dioxide, glycine, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polydimethyl siloxane, polysorbate, povidone, sodium carbonate, sodium hydroxide, talc, titanium dioxide, triethyl citrate|
Mesalamine Delayed Release Tablets USP, 500 mg
About this Medication
What the medication is used for
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.
What it does
SALOFALK is believed to work by interfering in the activity of certain mediators of inflammation (e.g., prostaglandins) which helps reduce the inflammation (swelling and pain) in the rectum and lower part of the large bowel.
When it should not be used
SALOFALK should not be used if:
- patients with severe kidney (renal) impairment (GFR<30ml/min/1.73m2) and/or severe liver (hepatic) impairment (see WARNINGS AND PRECAUTIONS).
- You are allergic to mesalamine or to any ingredient in the formulation (see What the non-medicinal ingredients are)
- You have stomach or small intestinal ulcers
- You have urinary tract obstructions
- You have a sensitivity to salicylates, for example acetylsalicylic acid (Aspirin)
- You are unable to swallow the intact tablet
- The patient is an infant under two years of age
What the medicinal ingredient is
SALOFALK tablets contain 500 mg mesalamine (me-SALa-meen), also known as 5-aminosalicylic acid, 5-ASA or mesalazine.
What the non-medicinal ingredients are
SALOFALK tablets contains carnauba wax, colloidal silicon dioxide, glycine, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polydimethyl siloxane, polysorbate, povidone, sodium carbonate, sodium hydroxide, talc, titanium dioxide, triethyl citrate. SALOFALK® tablets are gluten-free and phthalate-free.
What dosage form it comes in
SALOFALK 500 mg tablet is available for oral administration as an ochre-coloured (pale yellow), oblong, enteric-coated tablet.
SALOFALK 500 mg tablet is supplied in bottles of 150 and 500.
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 liver (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), 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.
WHILE using SALOFALK:
- 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.
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 bepossible.
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.
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 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.|
If you miss a dose of SALOFALK, use it as soon as possible, unless it is almost time for the next dose. Do not use two SALOFALK suppositories at the same time to make up for a missed dose.
Side Effects, how often they Happen and what to do about them
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.
|Symptom / Effect||Talk with your|
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This is not a complete list of side effects. For any unexpected effects while taking SALOFALK, contact your doctor or pharmacist.
How to Store it
SALOFALK tablets should be stored at controlled room temperature (15°-30°C). Protect from exposure to light.
Keep out of reach of children.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found by contacting the importer, Actavis Specialty Pharmaceuticals Co., at 1-855-892-8766